[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Fondazione IRCCS Istituto Nazionale dei Tumori, Milano\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":713},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,39,0,25,[9,40,70,97,119,140,160,193,220,244,274,301,325,365,388,413,437,464,486,508,571,602,628,655,684],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":16,"eligibilityCriteria":17,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":39},"100632379","matching-primary-tumor-and-blood-gene-expression-analysis-of-hpv-negative-squamous-head-and-neck-cancers-100632379",false,"NCT07512921","Matching Primary Tumor and Blood Gene Expression Analysis of HPV-negative Squamous Head and Neck Cancers","Matching Primary Tumor and Blood Gene Expression Analysis of HPV-negative Squamous Head and Neck Cancers (BIOMATCH - Head and Neck)","BIOMATCH","Inclusion Criteria:\n\n* Pathologic diagnosis of HNSCC\n* Primary HNSCC arising from the following sites of head and neck: oral cavity, p16-negative oropharynx, hypopharynx, larynx\n* Stage III-IVa\u002Fb according to the eighth edition of AJCC\u002FUICC classification\n* Treatment with curative intent\n* Unequivocal clinical and\u002For radiological absence of metastatic disease\n* Patient ability and availability to comply with study protocol procedures.-\n\nExclusion Criteria:\n\n* Recurrent\u002Fmetastatic HNSCC\n* p16+ oropharyngeal squamous cell carcinoma\n* Evidence of high-risk HPV infection at tumor level\n* Cancer of unknown primary site\n* Non-squamous head and neck cancers (e.g., lymphoma, sarcoma, melanoma, salivary gland cancers)\n* Skin squamous cell carcinoma from the skin of the head and neck\n* Nasopharyngeal carcinoma\n* Sinonasal\u002Fparanasal cancers\n* Insufficient data about previous medical history.","ALL","18 Years",{"count":21,"type":22},300,"ESTIMATED","OBSERVATIONAL","The goal of this observational study is to learn whether a blood test can show the same biological features as the tumor in people with head and neck cancer that is not caused by HPV. These cancers often have different biological types, and these types may help predict how the cancer will behave. Today, these types can only be found by studying tumor tissue. This study wants to see if a simple blood sample can give the same information.\n\nThe main questions the study aims to answer are:\n\n* Can a blood test identify the same tumor type that researchers find by studying tumor tissue under a microscope and through genetic testing?\n* Can these blood test results help predict how people may do after finishing treatment?\n\nResearchers will not assign treatments. All participants will receive the treatments recommended by their own care team as part of routine care.\n\nParticipants will:\n\n* Give a blood sample before starting treatment.\n* Give another blood sample about 3 months after finishing treatment.\n* Allow researchers to use a sample of their tumor (already collected as part of standard care) for genetic testing.\n* Continue routine follow-up visits with their care team.\n\nAbout 300 adults with locally advanced, HPV-negative head and neck cancer (affecting the mouth, throat, voice box, or hypopharynx) will take part. Only people who are receiving treatment to cure their cancer can join. People with returning cancer or cancer that has already spread cannot join.\n\nResearchers will study:\n\n* Gene activity in tumor tissue\n* Gene activity in blood\n* Patterns in blood fragments and small molecules\n* Digital images of tumor samples using computer-based tools\n\nThe study will compare these different types of information to see whether a blood test can reliably show the tumor's biological type. If it can, this could make it easier to monitor the cancer after treatment and may help guide future care.\n\nThis study does not test any new drug or treatment. It collects information that may help improve care for people with HPV-negative head and neck cancer in the future.",[26],"Head and Neck (HNSCC)","RECRUITING","2026-04-02",{"date":30,"type":31},"2026-04-06","ACTUAL",{"date":33,"type":31},"2025-02-18",{"date":35,"type":22},"2027-12-31",{"name":37,"class":38},"Fondazione IRCCS Istituto Nazionale dei Tumori, Milano","OTHER",2,{"id":41,"slug":42,"hasResults":12,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":46,"eligibilityCriteria":47,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":48,"targetDuration":50,"studyType":23,"phases":4,"briefSummary":51,"conditions":52,"keywords":55,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":69},"100547474","the-epithelioid-hemangioendothelioma-registry-of-the-european-reference-network-on-rare-adult-solid-cancers-euracan-100547474","NCT06408441","The Epithelioid Hemangioendothelioma Registry of the European Reference Network on Rare Adult Solid Cancers (EURACAN)","The Observational EURACAN Prospective Clinical Registry Dedicated to Epithelioid Hemangioendothelioma: the Protocol of an International and Collaborative Effort on an Ultra-rare Entity","EHE","Inclusion Criteria:\n\n* New patients managed by the contributing centers with a pathological EHE diagnosis performed or verified by an expert sarcoma pathologist starting from 1 December 2023 onwards and to be performed within 6 months from the registration\n* Molecular confirmation of the diagnosis (WWTR1-CAMTA1 or YAP1-TFE3)\n* Adult patients (aged ≥ 18 years)",{"count":49,"type":22},100,"6 Months","Epithelioid hemangioendothelioma (EHE) is an ultra-rare sarcoma, marked by distinctive molecular and pathological features and with a variable clinical behavior. Its natural history is still partially understood, reliable prognostic and predictive factors are lacking and many questions are still open on the optimal management. In the context of EURACAN, a prospective registry specifically dedicated to EHE was developed and launched with the aim of providing, through high-quality prospective data collection, a better understanding of this disease.\n\nThe study design is a registry-based cohort study including only new cases of patients with a pathological and molecularly confirmed diagnosis of EHE.\n\nThe objectives are to improve the understanding of EHE natural history, validate and identify new prognostic and predictive factors, clarify the activity and efficacy of currently available treatment options, describe treatment pattern.\n\nIt is an hospital-based registry established in centres with expertise in EHE including adult patients with a new pathological and molecularly confirmed diagnosis of EHE starting from the 1st December 2023. The characteristics of each patient in the facility who meets the above-mentioned inclusion criteria will be collected prospectively and longitudinally with follow-up at cancer progression and \u002F or cancer relapse or patient death.\n\nThe data analyses will include descriptive statistics and analytical analyses. Multivariable Cox's proportional hazards model and Hazard ratios (HR) for all-cause or cause-specific mortality will be used to determine independent predictors of overall survival, recurrence and progression.\n\nThe registry has been joined by 21 sarcoma reference centers across EU and UK, covering 10 countries. Patients' recruitment started in December 2023. The estimated completion date is December 2033 upon agreement on the achievement of all the registry objectives. The already established collaboration and participation of EHE patient's associations involved in the project will help in promoting the registry and fostering accrual.\n\nThis registry has been developed with the support of EHE Rare Cancer Charity UK, STATER (Grant Agreement number: 947604, HP-PJ-2019) and EURACAN 2022 (Grant Agreement number: 101085486, EU4H-2022-ERN-IBA) European Health and Digital Executive Agency (HaDEA)",[53,54],"Epithelioid Hemangioendothelioma","Sarcoma,Soft Tissue",[56,57,58,59,60],"rare cancers","soft tissue rare cancer","registry","protocol","ultra rare sarcomas","2026-03-30",{"date":63,"type":31},"2026-04-03",{"date":65,"type":31},"2023-12-01",{"date":67,"type":22},"2033-12-01",{"name":37,"class":38},22,{"id":71,"slug":72,"hasResults":12,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":76,"eligibilityCriteria":77,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":78,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":80,"conditions":81,"keywords":87,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":90,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":96},"100476395","the-head-and-neck-registry-of-the-european-reference-network-on-rare-adult-solid-cancers-100476395","NCT05483374","The Head and Neck Registry of the European Reference Network on Rare Adult Solid Cancers","The Observational Clinical Registry of the European Reference Network on Rare Adult Solid Cancers: the Protocol for the Rare Head and Neck Cancers","EURACAN","Inclusion Criteria:\n\n* Patients with epithelial tumours of nasopharynx; nasal cavity and paranasal sinuses; salivary gland cancer in large and small salivary glands; and middle ear (i.e. squamous carcinoma; adenocarcinoma; neuroendocrine; adenosquamous carcinoma, teratocarcinosarcoma, NUT carcinoma, odontogenic tumors) + neuroendocrine and adenocarcinoma in hypopharynx; oropharynx; larynx; oral cavity and lip + odontogenic carcinoma in oral cavity.\n* Adult patients (aged ≥18 years).\n* Diagnosis performed or verified by the expert centre entering the patient information in the registry.\n* Patients entering the HCP at any clinical phase of the disease (diagnosis, treatment of primary cancer, treatment of recurrence, treatment of M+ etc.). The HCP can decide, based on its resources, the number of patients on whom it can collect data.\n* New patients managed by the HCP from 2021 onwards plus patients managed by the HCP, who are actively followed up at the hospital, with year of diagnosis dating back to maximum 2018.\n\nExclusion Criteria:\n\n• Patients (aged \\\u003C 18 years)",{"count":79,"type":22},13600,"Cancer care for head and neck cancers is multidisciplinary and complex and knowledge on the rare ones is limited. There is a wide consensus that to support clinical research on rare cancers, clinical registries should be developed within networks specializing in rare cancers. Our hypothesis is that our head and neck cancer registry established in the framework of the European reference network on rare adults solid cancers will help to: describe the natural history of rare head and neck cancers; evaluate factors that influence prognosis; assess treatment effectiveness; measure indicators of quality of care.\n\nThe registry is a prospective observational real-world registry. It collects data from already available registries\u002Fdatabase and\u002For directly from expert health care providers (HCP). Information are prospectively collected on patient characteristics; exposure, outcomes and potential confounders (https:\u002F\u002Feuracan.eu\u002Fresearch\u002Fstarter\u002Frare-head-and-neck-cancer-registry\u002F#codebook).\n\nThe registry if federated (i.e. data are stored by the data provider). Analyses will be performed using the federated learning approach which split computations into a local part and a central part. The data providers will share sub-computations only. Data quality checks are envisioned to assess whether data value are present, valid and believable. Validity and plausibility checks are embedded in the electronic case report form (CRF) in the form of alerts and errors during the data input. Additional checks are implemented in R and run using the federated learning to ensure a central data quality monitoring. The data analyses will include descriptive statistics showing frequency and patterns of patients' and cancers' variables; analytical analyses investigating the association of patients\u002Fdisease and\u002For treatment characteristics and health outcomes.\n\nFondazione IRCCS Istituto Nazionale dei Tumori (INT) is the coordinator of the EURACAN registry as well as a data provider. At the INT, and at each HCP involved, responsible investigators ensure that the EURACAN registry will be implemented in compliance with the protocol, following the instructions and procedures described herein. Each HCP is a controller and will identify a data processor. The processing of patients' personal data taking part in the registry is compliant with local privacy legislation and the General Data Protection Regulation 2016\u002F679 of the EU.",[82,83,84,85,86],"Head and Neck Cancer","Nasopharynx Cancer","Nasal Cavity and Paranasal Sinus Cancer","Salivary Gland Cancer","Middle Ear Carcinoma",[88,89,58,59],"Rare cancers","head and neck cancers",{"date":63,"type":31},{"date":92,"type":31},"2022-05-31",{"date":94,"type":22},"2030-12-31",{"name":37,"class":38},10,{"id":98,"slug":99,"hasResults":12,"nctId":100,"briefTitle":101,"officialTitle":102,"acronym":103,"eligibilityCriteria":104,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":105,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":107,"conditions":108,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":111,"lastUpdatePostDateStruct":112,"startDateStruct":113,"completionDateStruct":115,"leadSponsor":117,"locationsCount":118},"100631968","a-multi-omics-approach-to-disclose-progression-and-underlying-biology-of-head-and-neck-adenoid-cystic-carcinoma-100631968","NCT07507578","A Multi-omics Approach to Disclose Progression and Underlying Biology of Head and Neck Adenoid Cystic Carcinoma","A Multi-omics Approach to Disclose Progression and Underlying Biology of Head and Neck Adenoid Cystic Carcinoma (MAPPING-ACC)","MAPPING-ACC","Inclusion Criteria:\n\n* Pathologic diagnosis of ACC\n* Primary ACC arising from the head and neck\n* Unequivocal clinical and\u002For radiological evidence of metastatic disease\n* Patient ability and availability to comply with study protocol procedures.\n\nExclusion Criteria:\n\n* ACC patients with local and\u002For regional recurrence without distant metastases\n* Primary ACC arising from any non-head and neck region (e.g., breast, lung, skin etc)\n* Insufficient data about previous medical history.",{"count":106,"type":22},114,"The goal of this observational study is to better understand why some people with metastatic adenoid cystic carcinoma (ACC) of the head and neck have slow-growing disease while others have faster-growing or more aggressive disease. Researchers want to learn how the biology of the tumor relates to each person's clinical risk group, which is based on a published prediction tool (a nomogram).\n\nThe main question the study aims to answer is: Do people in the high-risk and low-risk groups have different biological tumor types (called ACC-I and ACC-II) when their primary tumor is tested?\n\nThe study will also look at other important questions, such as:\n\n* Do metastatic tumors show the same biological type as the original tumor?\n* Do biological types differ based on where metastases grow or how early or late they appear?\n* Are biological types linked to how well systemic treatments work?\n* Can blood tests (including DNA fragments or small RNA molecules in the blood) show the same tumor biology and help track how the cancer changes over time?\n\nParticipants will:\n\n* Allow researchers to study samples of tumor tissue taken in the past during standard care.\n* Give blood samples at study entry and then every 6 months for up to 2 years.\n* Continue all medical treatments and follow-up visits as decided by their own care team.\n* Receive no study treatment; this study only collects information and samples.\n\nAbout 114 adults with metastatic ACC of the head and neck will join the study. People with only local or regional recurrence (without metastases) or those whose primary tumor started outside the head and neck cannot take part.\n\nThe information gathered may help researchers understand why ACC behaves differently from person to person, identify new biological markers in blood, and support future personalized treatment strategies for people with metastatic ACC.",[109,110],"Adenoid Cystic Carcinoma of the Salivary Gland","Adenoid Cystic Carcinoma of the Head and Neck","2026-03-27",{"date":28,"type":31},{"date":114,"type":31},"2025-03-01",{"date":116,"type":22},"2028-12-31",{"name":37,"class":38},1,{"id":120,"slug":121,"hasResults":12,"nctId":122,"briefTitle":123,"officialTitle":124,"acronym":4,"eligibilityCriteria":125,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":126,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":128,"conditions":129,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":111,"lastUpdatePostDateStruct":133,"startDateStruct":135,"completionDateStruct":137,"leadSponsor":139,"locationsCount":118},"100568375","epithelioid-haemangioendothelioma-observational-study-100568375","NCT06680401","Epithelioid Haemangioendothelioma Observational Study","The Evaluation of Cytokines and Hormones as Biomarkers for Epithelioid Haemangioendothelioma and Generation of Patient-derived Preclinical Models to Assess the Activity of Anticancer Agents and Validate Novel Therapeutic Targets","Inclusion Criteria:\n\n* Histological diagnosis of EHE according to 2020 WHO classification, performed on biopsy or surgical specimen\n* Signed informed consent\n* Adequate patient compliance to treatment or follow up\n* No age limit\n\nExclusion Criteria:\n\n* Impossibility to ensure adequate compliance",{"count":127,"type":22},50,"The EHE observational study was developed to obtain a high number of datas such as clinical presentation, natural history, and treatment outcomes, cto identificate cytokines and hormones as biomarkers and generate patient-derived preclinical models as a tool to assess the activity of anticancer agents and validate novel therapeutic targets",[130,131,132],"Clinical Presentation","Natural History","Treatment Outcomes",{"date":134,"type":31},"2026-04-01",{"date":136,"type":31},"2021-02-25",{"date":138,"type":22},"2028-12",{"name":37,"class":38},{"id":141,"slug":142,"hasResults":12,"nctId":143,"briefTitle":144,"officialTitle":145,"acronym":4,"eligibilityCriteria":146,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":147,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":149,"conditions":150,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":152,"lastUpdatePostDateStruct":153,"startDateStruct":154,"completionDateStruct":156,"leadSponsor":158,"locationsCount":159},"100631097","immunological-phenotype-of-desmoid-fibromatosis-affected-patients-100631097","NCT07496242","Immunological Phenotype of Desmoid-fibromatosis-affected Patients.","Immunological Profile of Patients With Desmoid-type Fibromatosis Under Active Surveillance.","Inclusion Criteria:\n\n* Patients with primary sporadic desmoid-type fibromatosis with measurable disease under active surveillance\n* Patients with primary sporadic desmoid-type fibromatosis with measurable disease receiving systemic treatment.",{"count":148,"type":22},200,"This observational study aims to characterize the molecular, phenotypic, and functional inflammatory and immunological profile of patients with sporadic desmoid-type fibromatosis undergoing either active surveillance or systemic therapy. The study includes analysis of the tumor immune microenvironment (TIME), circulating immune and inflammatory molecules, immune cell subsets, and circulating tumor DNA (ctDNA). The goal is to identify biomarkers associated with spontaneous or treatment-induced tumor regression and to evaluate potential correlations with specific ß-catenin mutations.",[151],"Desmoid-Type Fibromatosis","2026-03-23",{"date":111,"type":31},{"date":155,"type":31},"2025-05-27",{"date":157,"type":22},"2026-12",{"name":37,"class":38},8,{"id":161,"slug":162,"hasResults":12,"nctId":163,"briefTitle":164,"officialTitle":165,"acronym":4,"eligibilityCriteria":166,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":167,"enrollmentInfo":168,"targetDuration":4,"studyType":170,"phases":171,"briefSummary":174,"conditions":175,"keywords":177,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":184,"lastUpdatePostDateStruct":185,"startDateStruct":187,"completionDateStruct":189,"leadSponsor":191,"locationsCount":192},"100415416","phase-1-5fulv-irinotecan-temozolomide-and-bevacizumab-for-mgmt-silenced-microsatellite-stable-metastatic-colorectal-cancer-100415416","NCT04689347","5FU\u002FLV, Irinotecan, Temozolomide and Bevacizumab for MGMT Silenced, Microsatellite Stable Metastatic Colorectal Cancer.","Phase 1b\u002F2 Trial of 5-fluorouracil, Leucovorin, Irinotecan in Combination With Temozolomide (FLIRT) and Bevacizumab for the First-line Treatment of Patients With MGMT Silenced, Microsatellite Stable Metastatic Colorectal Cancer.","(applies to phase 2 part)\n\nInclusion criteria\n\n1. Histologically confirmed metastatic adenocarcinoma of the colon and\u002For rectum.\n2. Confirmed MGMT promoter methylation by PSQ (\\> 5%) and absent MGMT expression by immunohistochemistry.\n3. Locally assessed pMMR or MSS status.\n4. Written informed consent obtained prior to any study procedures.\n5. Availability of archival tumor tissue (primary tumor and metastases or at least one of the two) for confirmation of MGMT, MMR\u002FMSI status and biomarker analyses.\n6. Availability of blood sample for biomarker analysis.\n7. Metastatic colorectal cancer not previously treated with chemotherapy for metastatic disease.\n8. At least one measurable lesion according to RECIST 1.1.\n9. Age ≥ 18 and less or equal than 75 years.\n10. ECOG PS ≤ 1 if patient \\\u003C 70 years old; ECOG PS 0 if patient 70-75 years old.\n11. Life expectancy of at least 12 weeks.\n12. Previous (neo)adjuvant fluoropyrimidine or fluoropyrimidine plus oxaliplatin chemotherapy allowed only if more than 6 months elapsed between the end of (neo)adjuvant therapy and first evidence of disease relapse.\n13. Neutrophils ≥1.5 x 109\u002FL, Platelets ≥100 x 109\u002FL, Hemoglobin ≥ 9 g\u002Fdl.\n14. Total bilirubin ≤1.5 fold the upper-normal limits (UNL), AST (SGOT) and\u002For ALT (SGPT) ≤ 2.5 x UNL (or \\\u003C5 x UNL in the case of liver metastases), alkaline phosphatase ≤ 2.5 x UNL (or \\\u003C5 x UNL in case of liver metastases).\n15. Creatinine clearance ≥ 50 mL\u002Fmin or serum creatinine ≤1.5 x UNL.\n16. Women of childbearing potential must have a negative blood pregnancy test at the baseline visit. For this trial, women of childbearing potential are defined as all women after puberty, unless they are postmenopausal for at least 12 months, are surgically sterile, or are sexually inactive. A postmenopausal state is defined as no menses for 12 months without an alternative medical cause. A high follicle stimulating hormone (FSH) level in the postmenopausal range may be used to confirm a post-menopausal state in women not using hormonal contraception or hormonal replacement therapy. However, in the absence of amenorrhea, a single FSH measurement is insufficient.\n17. Male subjects with female partners of childbearing potential and female subjects of childbearing potential must be willing to use adequate contraception as approved be the Investigator (barrier contraceptive measure or oral contraception) as outlined in Section 7.6, starting with the screening visit and through 6 months after the last treatment dose. Note: abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject.\n18. Will and ability to comply with the protocol.\n19. Is willing and able to provide an adequate archival tumor sample (FFPE) available for molecular screening and exploratory analyses. If the tumor block is not available, a minimum of 25 3-micron unstained sections on charged slides of tumor will be required.\n\nExclusion criteria\n\n1. Requirement for treatment with any medicinal product that contraindicates the use of any of the study medications, may interfere with the planned treatment, affects patient compliance or puts the patient at high risk for treatment-related complications.\n2. Metastatic disease deemed R0 resectable upfront or after induction therapy by means of multidisciplinary team assessment.\n3. Radiotherapy to any site within 4 weeks before the study.\n4. Presence of one of the following: DPYD2a (c.1905+1G\\>A); DPYD13 (c.1679 T\\>G); DPYD D949V (c.2846 A\\>T); DPYD IVS10 (c.1129-5923 C\\>G).\n5. Presence of one of the following UGT1A1 1(TA)6\u002FUGT1A1 36(TA)5; UGT1A1 28(TA)7\u002FUGT1A1 37(TA)8 (homozygous genotype).\n6. In the dose escalation phase, untreated brain metastases or spinal cord compression or primary brain tumors; in the dose expansion phase, known history of brain metastases.\n7. History or evidence upon physical examination of central nervous system disease unless adequately treated.8. Active uncontrolled infections or other clinically relevant concomitant illness contraindicating chemotherapy administration.\n\n9\\. Evidence of bleeding diathesis or coagulopathy. 10. Uncontrolled hypertension and prior history of hypertensive crisis or hypertensive encephalopathy.\n\n11\\. Clinically significant (i.e. active) cardiovascular disease for example cerebrovascular accidents (≤6 months), myocardial infarction (≤6 months), unstable angina, New York Heart Association (NYHA) grade II or greater congestive heart failure, serious cardiac arrhythmia requiring medication.\n\n12\\. Significant vascular disease (e.g. aortic aneurysm requiring surgical repair or recent arterial thrombosis) within 6 months of study enrolment.\n\n13\\. Any previous venous thromboembolism ≥ NCI CTCAE Grade 4. 14. History of abdominal fistula, gastrointestinal perforation, intra-abdominal abscess or active gastrointestinal bleeding within 6 months prior to the first study treatment.\n\n15\\. Treatment with any investigational drug within 30 days prior to enrollment or 2 investigational agent half-lives (whichever is longer).\n\n16\\. Other co-existing malignancies or malignancies diagnosed within the last 3 years with the exception of localized basal and squamous cell carcinoma or cervical cancer in situ.\n\n17\\. Lack of physical integrity of the upper gastrointestinal tract, malabsorption syndrome, or inability to take oral medication.\n\n18\\. Known hypersensitivity to trial drugs or hypersensitivity to any other component of the trial drugs.\n\n19\\. Any concomitant drugs contraindicated for use with the trial drugs according to the product information of the pharmaceutical companies.\n\n20\\. Pregnant or lactating women.","75 Years",{"count":169,"type":22},27,"INTERVENTIONAL",[172,173],"PHASE1","PHASE2","An upfront-intensified treatment combining all the three active cytotoxic agents in metastatic colorectal cancer (mCRC) including fluoropyrimidines, oxaliplatin, irinotecan (FOLFOXIRI) plus antiangiogenic blockade with bevacizumab significantly improved survival. No biomarkers are available for predicting sensitivity\u002Fresistance to single chemotherapeutic drugs, the simultaneous delivery of all active chemotherapeutic agents might overcome resistance to single drugs.\n\nTemozolomide has modest but non-negligible activity (about 10%) in chemo-refractory patients with MGMT methylated mCRC. The response rate to temozolomide-based therapy in pretreated patients is increased to up to 20% when restricting the focus on those with MGMT IHC-negative\u002FMGMT methylated and MSS cancers. Clinical and preclinical synergy has been reported for combination of temozolomide with irinotecan and fluoropyrimidines. Temozolomide could be regarded as a \"targeted\" chemotherapy for patients with MSS and MGMT silenced tumors. In this subgroup of patients, an intensified triplet upfront regimen including temozolomide, fluoropyrimidines, irinotecan, associated with bevacizumab, could be a novel combination in molecularly super-selected mCRC patients.\n\nMoving from this, the investigators designed this open-label, monocentric, phase 1b study evaluating the safety of the combination regimen 5-fluorouracil, leucovorin, irinotecan, temozolomide and bevacizumab in patients with MGMT silenced and MSS mCRC.\n\nThe study will consist in a dose-escalation assessment of the safety of the treatment in subjects with previously untreated MGMT silenced, MSS mCRC. A 3 + 3 design will be used to assess the maximum tolerated dose (MTD) or maximum tested dose of the combination FLIRT-bevacizumab. Upon completion of the phase 1b part, the phase 2 part of the study will start.",[176],"Metastatic Colorectal Cancer",[178,179,180,181,182,183],"Temozolomide","MGMT","microsatellite stable","First-line","Phase 1","Colorectal cancer","2026-01-08",{"date":186,"type":31},"2026-01-12",{"date":188,"type":31},"2021-01-01",{"date":190,"type":22},"2027-01-31",{"name":37,"class":38},3,{"id":194,"slug":195,"hasResults":12,"nctId":196,"briefTitle":197,"officialTitle":198,"acronym":199,"eligibilityCriteria":200,"healthyVolunteers":12,"sex":201,"minAge":19,"maxAge":202,"enrollmentInfo":203,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":204,"conditions":205,"keywords":207,"overallStatus":211,"whyStopped":4,"lastUpdateSubmitDate":212,"lastUpdatePostDateStruct":213,"startDateStruct":215,"completionDateStruct":217,"leadSponsor":219,"locationsCount":118},"100577540","prognostic-role-of-molecular-classification-in-fertility-sparing-treatment-of-endometrial-cancer-100577540","NCT06799624","Prognostic Role of molEcular classiFication in Fertility-sparing treAtment of Endometrial canCEr","Prognostic Role of molEcular classiFication in Fertility-sparing treAtment of Endometrial canCEr: PREFACE Study","PREFACE","Inclusion Criteria:\n\n1. Patients aged 18-45 years with a hysteroscopic confirmed diagnosis of endometrial cancer (FIGO stage IA without myometrial invasion, grade 1 or grade 2, endometrioid histology).\n2. Patients desiring fertility preservation\n3. Molecular classification of the tumor using next-generation sequencing (NGS) or Proactive Molecular Risk Classifier for Endometrial Cancer (ProMisE).\n4. Adequate pre-treatment imaging (MRI or transvaginal ultrasound) confirming no evidence of myometrial invasion or extrauterine spread.\n\nExclusion Criteria:\n\n1. Patients with atypical endometrial hyperplasia or intraepithelial neoplasia\n2. Individuals with tumor samples of insufficient quantity or inadequate quality were not included in the analysis\n3. Non-endometrioid histology.\n4. Patients with a history of prior uterine malignancy or current synchronous malignancies.\n5. Medical contraindications to hormonal therapy","FEMALE","50 Years",{"count":49,"type":22},"Endometrial cancer, the most common gynecologic malignancy in high-income countries, is increasing among reproductive-age women. While hysterectomy prevents pregnancy, hormonal therapies offer fertility-sparing options for select early-stage cases, with \\~80% achieving complete response (CR). Molecular classifications (POLEmut, p53abn, MMRd\u002FMSI-H, NSMP) reveal subtype-specific prognostic differences, with NSMP showing higher CR rates and lower recurrence, while p53abn and MMRd\u002FMSI-H fare worse. Recent studies emphasize molecular profiling's potential to guide personalized fertility-sparing treatments. This study explores the prognostic role of these classifications in treatment outcomes.",[206],"Uterine Cancer",[208,209,210],"uterine cancer","fertility-sparing","molecular classification","NOT_YET_RECRUITING","2025-12-16",{"date":214,"type":31},"2025-12-23",{"date":216,"type":22},"2026-01-01",{"date":218,"type":22},"2028-01-31",{"name":37,"class":38},{"id":221,"slug":222,"hasResults":12,"nctId":223,"briefTitle":224,"officialTitle":225,"acronym":226,"eligibilityCriteria":227,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":228,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":229,"conditions":230,"keywords":231,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":236,"lastUpdatePostDateStruct":237,"startDateStruct":239,"completionDateStruct":241,"leadSponsor":243,"locationsCount":118},"100612424","microbiota-guided-radiotherapy-for-head-and-neck-cancer-100612424","NCT07253402","Microbiota-guided Radiotherapy for Head and Neck Cancer","MIcrobiota-Guided RAdiotherapy for Head and Neck Cancer. (MIGRHAN)","MIGRAHN","Inclusion Criteria:\n\n* Age ≥ 18 years.\n* ECOG Performance Status ≤ 3.\n* Histological diagnosis of squamous cell carcinoma, undifferentiated carcinoma, epithelial glandular and non-glandular carcinoma (including adenoid cystic carcinoma, adenocarcinoma, mucoepidermoid carcinoma, neuroendocrine carcinoma, etc.) originating from the oral cavity, oropharynx, nasopharynx, hypopharynx, larynx, salivary glands, paranasal sinuses, or from an unknown primary site.\n* Stage III-IV non-metastatic disease for pharyngeal, laryngeal, or unknown-primary tumors, according to AJCC 7th edition. Patients with stage III-IV tumors of salivary gland or paranasal sinus origin, and patients with stage I-II pharyngeal or laryngeal tumors, will only be included if prophylactic irradiation of cervical lymph node stations is indicated and\u002For if the oral and oropharyngeal mucosa as well as swallowing-related structures are included within the irradiated volume.\n* Indication for treatment in either definitive or adjuvant settings, with or without systemic therapy (concurrent systemic therapy, with or without prior neoadjuvant chemotherapy, permitted. Adjuvant systemic therapy is allowed for selected advanced stages of pharyngeal carcinoma, according to institutional guidelines).\n* Formal acceptance of study participation requirements (written informed consent).\n\nExclusion Criteria:\n\n* Prior radiotherapy to the head-neck region.\n* Presence of connective tissue disorders (e.g., lupus erythematosus or scleroderma) or synchronous head and neck malignancies, except for superficial skin cancers or surgically treated carcinoma in situ not requiring radiotherapy or systemic therapy.\n* Absence of formal acceptance of study participation requirements (written informed consent).\n* Indication for treatment exclusively in the postoperative setting.",{"count":49,"type":22},"Head and neck cancer (HNC) is the sixth most common cancer worldwide. Therapeutic outcomes for HNC remain unsatisfactory and heterogeneous, with 5-year survival rates ranging from 28% to 67% overall. Moreover, HNC patients experience side effects during treatment, including inflammation and ulceration of the oral mucosa caused by radiation or cytotoxic agents (oral mucositis), which represents a limiting factor for both the escalation of radiotherapy dosage and the duration of treatment.\n\nSeveral observational studies have highlighted statistical associations between the oral microbiota and numerous factors related to HNC and its therapeutic course. The working hypothesis of this study is that it is possible to establish causal relationships between the functional traits of the human oral microbiota and the effectiveness of radiotherapy in HNC treatment, directly from the analysis of data collected in observational cohorts, by leveraging the statistical framework of causal inference.\n\nThe oral microbiota of HNC patients enrolled in the study will be characterised through metagenomic sequencing of saliva samples collected from each patient, at radiotherapy-baseline, at 2 weeks from radiotherapy start and at radiotherapy end.\n\nMain Objectives of the Study:\n\n* Creation of a dataset of the oral microbiota in HNC patients, including both bacterial and viral components, as well as data linked to treatment effectiveness and side effects.\n* Estimation of the causal effect of the functional traits of the oral microbiota on the modulation of radiotherapy in HNC.\n* Development of predictive models for local tumour control and for oral mucositis, based on the oral microbiota of HNC patients.\n\nClinical Relevance:\n\nThe causal relationships inferred between the functional\u002Fmetabolic traits of the microbiota and radiotherapy effectiveness will help build interpretable predictive models and reveal strategies to reprogram the microbiota functionality of patients with head and neck cancer. This will increase the likelihood of tumour eradication or control while reducing the risk of radiation-induced side effects.",[82],[232,233,234,235,82],"Oral microbiota","Radiotherapy","Tumour control","Oral mucositis","2025-11-19",{"date":238,"type":31},"2025-11-28",{"date":240,"type":31},"2025-10-15",{"date":242,"type":22},"2031-10-30",{"name":37,"class":38},{"id":245,"slug":246,"hasResults":12,"nctId":247,"briefTitle":248,"officialTitle":249,"acronym":250,"eligibilityCriteria":251,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":252,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":253,"conditions":254,"keywords":264,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":266,"lastUpdatePostDateStruct":267,"startDateStruct":269,"completionDateStruct":271,"leadSponsor":273,"locationsCount":39},"100608251","duodenal-polyposis-classification-in-fap-100608251","NCT07199127","Duodenal Polyposis Classification in FAP","Novel Endoscopic Classification for Duodenal Polyposis in Individuals With Familial Adenomatous Polyposis","DRACO","Inclusion Criteria:\n\n* Confirmed germline diagnosis of FAP, as defined by genetic testing\n* Two or more upper gastrointestinal endoscopies\n* Complete documentation of all Spigelman classification variables at each endoscopic evaluation\n\nExclusion Criteria:\n\n* Histological grading of duodenal polyps incomplete\n* Follow-up data were unavailable\n* Duodenal surgery before study baseline endoscopy",{"count":21,"type":22},"Duodenal cancer is the leading cause of cancer-related mortality in patients with familial adenomatous polyposis (FAP), yet the current Spigelman staging system provides limited predictive accuracy for advanced neoplasia. The DRACO study (Duodenal Risk Assessment in adenomatous polyposis Coli -Oncogene) is a multicenter, STROBE- and CONSORT-compliant cohort study that analyzes upper endoscopies from genetically confirmed FAP patients across independent cohorts to develop, validate, and externally test two multivariable risk models.",[255,256,257,258,259,260,261,262,263],"Duodenum Cancer","Familial Adenomatous Polyposis","Duodenal Polyposis","Ampulla of Vater Adenoma","FAP Gene Mutation","FAP","Duodenal Neoplasms","Duodenal Adenoma","Ampulla of Vater Cancer",[265,257],"Spigelman","2025-09-22",{"date":268,"type":31},"2025-09-30",{"date":270,"type":31},"2018-02-02",{"date":272,"type":22},"2030-01-15",{"name":37,"class":38},{"id":275,"slug":276,"hasResults":12,"nctId":277,"briefTitle":278,"officialTitle":279,"acronym":280,"eligibilityCriteria":281,"healthyVolunteers":12,"sex":201,"minAge":19,"maxAge":4,"enrollmentInfo":282,"targetDuration":4,"studyType":170,"phases":284,"briefSummary":285,"conditions":286,"keywords":288,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":293,"lastUpdatePostDateStruct":294,"startDateStruct":296,"completionDateStruct":298,"leadSponsor":300,"locationsCount":118},"100588232","phase-2-omission-of-local-therapies-in-women-patients-with-her2-positive-or-triple-negative-breast-cancer-100588232","NCT06938724","Omission of Local Therapies in Women Patients With HER2-positive or Triple-negative Breast Cancer","Omission of Local Therapies in Women Patients With HER2-positive or Triple-negative Breast Cancer: A Two Arm, Phase 2, Non-inferiority Trial for Surveillance in Maximum Responders to Neoadjuvant Systemic Therapy","OLT","Inclusion Criteria:\n\n* Women ≥ 18y.\n* Initial diagnosis of unifocal HER2-positive (regardless of HR status) or Triple-negative (HR positivity lower than 10% is allowed) T1-2, N0-1, M0 breast cancer.\n* Treated with neoadjuvant systemic treatment according to the center recommendations.\n* Maximum responders and\u002For complete pathological response proved by surgery.\n* Scheduled for breast conservation.\n* Giving specific informed consent.\n\nExclusion Criteria:\n\n* One of the inclusion criteria missed.\n* Residual ductal carcinoma in situ (DCIS) at VABB and\u002For surgery.\n* Bilateral synchronous breast cancer.\n* Previous malignancy within 5 years.\n* BRCA1-2, PALB2 or p53 proven mutation carrier (VUS are exclusion criteria as well).\n* Patients unable to perform regular follow up.",{"count":283,"type":22},152,[173],"HER2-positive and Triple-negative are subtypes of breast cancer more sensitive to systemic therapies, where the complete pathological response rate may be higher than 50%. This gave rise to doubts about the usefulness of traditional local treatments for such responders. Omission of surgery after vacuum assisted breast biopsy (VABB) as well omission of radiotherapy after conservative surgery would now seem to be reasonable alternatives to standard care for highly selected patients, in whom systemic treatments have provided the maximum response.",[287],"Breast Neoplasm Malignant Female",[289,290,291,292],"Surveillance for breast cancer relapses","Omission of local therapies","Omission of surgery","Omission of radiotherapy","2025-09-12",{"date":295,"type":31},"2025-09-15",{"date":297,"type":31},"2025-07-25",{"date":299,"type":22},"2035-07-25",{"name":37,"class":38},{"id":302,"slug":303,"hasResults":12,"nctId":304,"briefTitle":305,"officialTitle":306,"acronym":307,"eligibilityCriteria":308,"healthyVolunteers":12,"sex":309,"minAge":19,"maxAge":4,"enrollmentInfo":310,"targetDuration":4,"studyType":170,"phases":312,"briefSummary":314,"conditions":315,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":317,"lastUpdatePostDateStruct":318,"startDateStruct":320,"completionDateStruct":322,"leadSponsor":324,"locationsCount":192},"100489194","multimodal-approach-in-patients-with-mhspc-randomized-trial-of-apaadt-vs-apa-adt-and-local-treatment-100489194","NCT05649943","Multimodal Approach in Patients With mHSPC. Randomized Trial of APA+ADT vs APA-ADT and Local Treatment","APPROACH : Multimodal Approach in Patients With mHSPC. A Pragmatic Randomized Trial of Apalutamide Plus Androgen Deprivation Therapy (APA-ADT) Versus APA-ADT Plus Local Treatment. A Meet-URO 29 Study","APPROACH","Inclusion Criteria:\n\n* Age \\> 18\n* Histologically confirmed diagnosis of prostate adenocarcinoma\n* Metastatic disease documented by ≥1 bone lesion with Technetium 99m (99mTc) bone scan. Individuals with only one bone lesion should have confirmation of that lesion on CT or MRI.\n* Eastern Cooperative Oncology Group Performance Status (ECOG PS) Grade ≤ 2\n* No previous treatment with antiandrogens or GnRH analogues, or a treatment ≤ 3 months.\n* No previous systemic or local treatment for prostate adenocarcinoma, including pelvic radiotherapy.\n* Laboratory values at the time of screening:\n\n  a. Neutrophils ≥ 1500\u002FμL b. Hemoglobin ≥ 9.0 mg\u002FμL (no transfusions in the past 28 days) c. Platelets ≥ 100,000\u002FμL d. Creatinine ≤ 2 x upper limit of normal and serum albumin ≥ 3.0 g\u002FdL f. Total bilirubin ≤ 1.5 x upper limit of normal \\[NOTE: In subjects with Gilbert syndrome, if total bilirubin is \\>1.5 x ULN, measure direct and indirect bilirubin, and if direct bilirubin is ≤ 1.5 x ULN subjects may be eligible\\]; g. AST and ALT ≤ 2.5 x upper limit of normal\n* Able to swallow Apalutamide tablets whole.\n* All subjects must sign an Informed Consent Form indicating that they understand the purpose of the study and its procedures and intend to participate. The subject must be willing and must be able to comply with the restrictions specified in this protocol.\n\nInclusion criteria for cytoreductive surgery:\n\n* Age \\>18 years\n* Clinical stage cT3\n* Robot-assisted radical prostatectomy with iliac obturator lymphadenectomy\n* Surgical piece management criteria similar to Proteus criteria.\n\nExclusion Criteria:\n\n* Pathologic findings consistent with small cell, ductal, or neuroendocrine prostate cancer.\n* Known brain metastases.\n* Lymph node metastases only.\n* Visceral metastases.\n* Patients not eligible for surgery or radiotherapy.\n* Unacceptable increase in cardiovascular risk, defined as the occurrence of at least one of the following episodes in the 6 months prior to randomization: unstable angina, myocardial infarction, symptomatic congestive heart failure, clinically significant thromboembolic events (e.g., pulmonary embolism), or clinically significant ventricular arrhythmias .\n* Uncontrolled high blood pressure (systolic blood pressure \\> 160 mmHg or diastolic blood pressure \\> 100 mmHg).\n* Previous treatment with antiandrogens, GnRH analogues, or other systemic treatments for adenocarcinoma of the prostate.\n* Previous local treatment with surgery and\u002For radiotherapy.\n* Any prior malignancy (except adequately treated basal cell carcinoma or a squamous cell skin carcinoma, superficial bladder carcinoma, or any other in situ carcinoma currently in complete remission) within 5 years of randomization.\n* Known allergies, hypersensitivity or intolerance to the excipients of Apalutamide.\n* Patients who, within 28 days prior to randomisation, have received:\n\n  1. transfusions (red blood cells and\u002For platelets);\n  2. hematopoietic growth factors;\n  3. major surgery.\n* Symptomatic and\u002For chronic viral hepatitis; chronic liver disease; moderate or severe liver failure (class B and C according to the Child-Pugh scale); encephalopathy, ascites or thrombo-haemorrhagic disorders secondary to liver failure.\n* Gastrointestinal disorders affecting drug absorption\n* Active infections requiring systemic therapy such as human immunodeficiency virus (HIV);\n* Any condition or situation which, in the judgment of the investigator, precludes participation in this trial.\n\nExclusion criteria for cytoreductive surgery:\n\n* Contraindication for surgery","MALE",{"count":311,"type":22},566,[313],"NA","Italian multicenter study, will enroll \\~566 pts with oligometastatic hormone sensitive prostate cancer who are candidates to receive treatment with apalutamide.\n\nAfter 6 months from the start of treatment, patients will be randomized to receive local treatment based on the investigator's choice ( either one between primary radiotherapy or cytoreductive prostatectomy), in addition to apalutamide, or to continue just with medical therapy.",[316],"Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)","2025-09-02",{"date":319,"type":31},"2025-09-03",{"date":321,"type":31},"2023-03-01",{"date":323,"type":22},"2029-01-01",{"name":37,"class":38},{"id":326,"slug":327,"hasResults":12,"nctId":328,"briefTitle":329,"officialTitle":329,"acronym":330,"eligibilityCriteria":331,"healthyVolunteers":12,"sex":18,"minAge":4,"maxAge":4,"enrollmentInfo":332,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":334,"conditions":335,"keywords":352,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":357,"lastUpdatePostDateStruct":358,"startDateStruct":360,"completionDateStruct":362,"leadSponsor":364,"locationsCount":118},"100595293","radiomics-to-predict-her2-status-and-t-dxd-efficacy-in-metastatic-breast-cancer-the-radiospher2-study-100595293","NCT07030569","RADIomics to Predict HER2 Status And T-DXd Efficacy in Metastatic Breast Cancer: the RADIOSPHER2 Study","RADIOSPHER2","Inclusion Criteria:\n\n* Patients with metastatic breast cancer underwent a liver, lung, pleural or bone biopsy in the metastatic setting, performed from 01Jan2005 to 01Jan2024.\n\nExclusion Criteria:\n\n* Not available imaging (CT scan and\u002For PET-FdG scan) in the three months before the biopsy or before the last previous treatment interruption;\n* Unknown HER2 status;\n* Node, soft tissue or other visceral as biopsy site.",{"count":333,"type":22},500,"RADIOSPHER2 study is a monocentric, retrospective, observational study aiming at identifying a radiomics signature able to predict HER2 expression (0 vs low vs overexpression) and trastuzumab deruxtecan efficacy in metastatic breast cancer patients. The study also encompasses translational analyses and inter-modal correlations in order to provide novel insights about HER2 spatial and temporal heterogeneity, at the macroscopic and microscopic levels.",[336,337,338,339,340,341,342,343,344,345,346,347,348,349,350,351],"Radiomic","Radiomics","Breast Cancer Metastatic","Breast Cancer Stage IV","Breast Carcinoma","Breast Neoplasms","Breast Cancer","Breast Cancer With Bone Metastasis","Breast Cancer With Metastatic Bone Disease","Trastuzumab","HER2","HER2 + Breast Cancer","HER2 Positive Breast Carcinoma","HER2-positive Breast Cancer","Her2\u002FNeu Positive Advanced Solid Tumors","HER2\u002FNeu-positive Breast Cancer",[337,353,354,355,356],"HER2 expression","Trastuzumab Deruxtecan","Pathomics","HER2 heterogeneity","2025-06-12",{"date":359,"type":31},"2025-06-22",{"date":361,"type":31},"2024-02-01",{"date":363,"type":22},"2027-01-01",{"name":37,"class":38},{"id":366,"slug":367,"hasResults":12,"nctId":368,"briefTitle":369,"officialTitle":369,"acronym":370,"eligibilityCriteria":371,"healthyVolunteers":12,"sex":201,"minAge":19,"maxAge":4,"enrollmentInfo":372,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":374,"conditions":375,"keywords":377,"overallStatus":211,"whyStopped":4,"lastUpdateSubmitDate":380,"lastUpdatePostDateStruct":381,"startDateStruct":383,"completionDateStruct":385,"leadSponsor":387,"locationsCount":118},"100592929","revisiting-the-concept-of-nerve-sparing-radical-hysterectomy-100592929","NCT06999824","Revisiting the Concept of Nerve Sparing Radical Hysterectomy","Neuro-Nerve","Inclusion Criteria: (i) age ≥18 years; (ii) histologically confirmed cervical cancer; (iii) indication for type C1 (nerve-sparing) radical hysterectomy according to ESGO guidelines; and (iv) a minimum of 90 days of postoperative follow-up. Exclusion Criteria: (i) withdrawal of consent; (ii) prior abdominal and\u002For pelvic surgery; (iii) pre-existing urinary incontinence, detrusor overactivity, or detrusor underactivity; and (iv) pre-existing anorectal dysfunction Staging and architectural grade were defined according to the 2018 International Federation of Gynecology and Obstetrics (FIGO) recommendations, and histological subtypes were classified based on the World Health Organization (WHO) criteria",{"count":373,"type":22},15,"Nerve-sparing radical hysterectomy aims to preserve the autonomic innervation of pelvic organs. In most studies, the preservation of the parasympathetic component of pelvic innervation is achieved by sparing the lymphovascular-neural tissue located at the base of the lateral paracervical tissue. This study explores an alternative surgical technique based on a different anatomical pathway of parasympathetic fibers, running more cranially and deeply within the pararectal space.",[376],"Cervical Cancers",[378,379],"cervical cancer","radical hysterectomy","2025-05-22",{"date":382,"type":31},"2025-05-31",{"date":384,"type":22},"2025-06-01",{"date":386,"type":22},"2027-05-01",{"name":37,"class":38},{"id":389,"slug":390,"hasResults":12,"nctId":391,"briefTitle":392,"officialTitle":393,"acronym":394,"eligibilityCriteria":395,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":396,"enrollmentInfo":397,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":398,"conditions":399,"keywords":402,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":406,"lastUpdatePostDateStruct":407,"startDateStruct":409,"completionDateStruct":410,"leadSponsor":412,"locationsCount":118},"100591904","liver-transplantation-for-unresectable-perihilar-cholangiocarcinoma-100591904","NCT06986486","Liver Transplantation for Unresectable Perihilar Cholangiocarcinoma","Neoadjuvant Chemotherapy and Stereotactic Body Radiation Therapy Followed by Liver Transplantation for Unresectable Perihilar Cholangiocarcinoma: pCOLA","pCOLA","Inclusion Criteria:\n\n* Diagnosis of unresectable peripheral cholangiocarcinoma arising one centimeter or more above the superior pancreatic margin, with tumor diameter ≤ 3 cm, diagnosed by:\n* Transcatheter biopsy or brush cytology\n* CA-19.9 \\> 100 mg\u002Fml and\u002For a mass on cross-sectional imaging with a malignant appearing stricture on cholangiography\n* Biliary ploidy by FISH with a malignant appearing stricture on cholangiography\n* Age between 18 years and 70 years\n* Absence of intra- and extrahepatic metastases\n* Absence of lymph-nodal metastases at any site\n* Biliary stenting of all liver districts\n* No contraindications to liver transplantation\n* No concomitant malignancies or history of other malignancies in the previous 5 years\n* Written informed consent\n\nExclusion Criteria:\n\n* Intrahepatic cholangiocarcinoma\n* Uncontrolled infection\n* Concomitant malignancies or history of other malignancies in the previous 5 years","70 Years",{"count":159,"type":22},"This is multicentric, single-arm, observational, investigator-drive study investigating the efficacy of liver transplantation after successful downstaging\u002Fdisease control of unresectable perihilar cholangiocarcinoma using chemotherapy +\u002F- immunotherapy and stereotactic body radiation therapy (SBRT).",[400,401],"Perihilar Cholangiocarcinoma","Klatskin Tumor",[403,404,405],"liver transplantation","stereotactic body radiation therapy","downstaging","2025-05-15",{"date":408,"type":31},"2025-05-23",{"date":384,"type":22},{"date":411,"type":22},"2030-01-01",{"name":37,"class":38},{"id":414,"slug":415,"hasResults":12,"nctId":416,"briefTitle":417,"officialTitle":418,"acronym":4,"eligibilityCriteria":419,"healthyVolunteers":12,"sex":201,"minAge":19,"maxAge":4,"enrollmentInfo":420,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":421,"conditions":422,"keywords":427,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":429,"lastUpdatePostDateStruct":430,"startDateStruct":432,"completionDateStruct":434,"leadSponsor":436,"locationsCount":118},"100511342","multimodality-treatments-of-hpv-related-lesions-of-the-female-genital-tract-100511342","NCT05938192","Multimodality Treatments of HPV-related Lesions of the Female Genital Tract","Predictors of Recurrence After Treatment (Surgery Plus Vaccination) of HPV-related Disease of the Female Genital Tract","Inclusion Criteria:\n\n* Patients with HPV related disease\n\nExclusion Criteria:\n\n* consent withdrawal",{"count":148,"type":22},"Cervical cancer is one of the most preventable types of cancer, as it develops over an extended period, and its causative agent is well-known. Persistent infection with human papillomavirus (HPV) is the primary factor causing cervical cancer. Generally, persistent HPV infection leads to cervical dysplasia (also known as cervical intraepithelial neoplasia), which can potentially progress to cancer. Although the majority of women with HPV infection will never develop lesions, a relatively high number of women remain at risk of developing cervical dysplasia. Women with cervical dysplasia who receive appropriate follow-up and treatment are at low risk of developing cervical cancer. However, recurrent cervical dysplasia is a well-known risk factor for cervical cancer. Furthermore, recurrent cervical dysplasia can contribute to morbidity, as additional surgical treatments are associated with fertility and obstetric complications in women who wish to preserve their childbearing potential. Against this background, identifying the best treatment modality for patients with cervical dysplasia is of paramount importance.\n\nThe management of residual or recurrent dysplasia after primary treatment is often challenging. Moreover, it is important to classify patients based on their risk of having persistent or recurrent dysplasia following initial treatment. Assessing these risk categories is useful in tailoring appropriate surveillance and determining the need for adjunctive treatments. Our research group has estimated the risk of developing persistent or recurrent dysplasia in several investigations, identifying positive surgical margins, surgical techniques, high-risk HPV infection at the time of diagnosis, and HPV persistence as key prognostic factors. Our findings align with a substantial body of literature investigating this issue. However, accurately estimating the risk of persistent or recurrent dysplasia for each individual patient remains challenging.\n\nSimilarly, few studies have evaluated the outcomes of patients affected by vaginal intraepithelial neoplasia, and results have been inconsistent. In fact, there is no consensus on the optimal treatment modality for these patients. Treatments have included topical applications of imiquimod or 5-fluorouracil (5-FU), as well as ablative and excisional procedures performed via conventional surgery, electrosurgery, and carbon dioxide laser. The risk of developing invasive vaginal cancer in these patients remains uncertain, with estimates ranging between 2% and 12% in different series. Recently, a multi-institutional Italian study reported that more than 10% of women initially diagnosed with high-grade vaginal intraepithelial neoplasia were found to have occult invasive vaginal cancer at the time of excisional procedures, highlighting the need for histological diagnosis before proceeding with ablative or medical treatments. Additionally, the widespread implementation of HPV vaccination is expected to reduce the risk of recurrence after treatment.\n\nIn this context, the investigators aim to evaluate the significance of post-treatment HPV vaccination and other prognostic factors in influencing the risk of persistent or recurrent lesions of the uterine cervix and vagina.",[423,424,425,426],"HPV","Cervical Cancer","Cervix Lesion","Vagina Disease",[428],"hpv","2025-05-06",{"date":431,"type":31},"2025-05-09",{"date":433,"type":31},"2020-07-15",{"date":435,"type":22},"2028-12-30",{"name":37,"class":38},{"id":438,"slug":439,"hasResults":12,"nctId":440,"briefTitle":441,"officialTitle":441,"acronym":442,"eligibilityCriteria":443,"healthyVolunteers":444,"sex":18,"minAge":19,"maxAge":445,"enrollmentInfo":446,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":448,"conditions":449,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":456,"lastUpdatePostDateStruct":457,"startDateStruct":459,"completionDateStruct":461,"leadSponsor":463,"locationsCount":118},"100487035","quantifying-systemic-immunosuppression-to-personalize-cancer-therapy-100487035","NCT05621837","Quantifying Systemic Immunosuppression to Personalize Cancer Therapy","Serpentine","Inclusion Criteria\n\n* Histologically documented diagnosis of metastatic\u002Flocally advanced melanoma, hormone-refractory breast cancer, RCC and UC, SCCHN, SCC or NSCLC, stage III resectable NSCLC will also be included\n* Will and ability to comply with the protocol\n* Willingness and ability to provide an adequate archival Formalin-Fixed Paraffin-Embedded (FFPE) tumor sample available for exploratory biomarker analysis\n* Age from 18 to 90 years at the time of recruitment\n* ECOG Performance Status \\\u003C= 2\n* Understanding and signature of the informed consent\n* Consenting to participate to the socio-economical-psychological survey\n\nExclusion Criteria\n\n* Known history of HIV infection\n* Serious neurological or psychiatric disorders\n* Pregnancy or lactation\n* Inability or unwillingness of participant to give written informed consent\n* Inability or unwillingness to be regularly followed up at the same center",true,"90 Years",{"count":447,"type":22},1000,"The Serpentine (Stratify cancER PatiENTs by ImmuNosupprEssion) project, represents the most consistent effort so far attempted to translate MDSC into clinical practise by producing an off-the-shelf compliant assay for quantifying these cells in peripheral blood.",[450,342,451,452,453,454,455],"Melanoma","Renal Cell Carcinoma","Urinary Bladder Cancer","Squamous Cell Carcinoma of Head and Neck","Small Cell Carcinoma","NSCLC","2025-04-29",{"date":458,"type":31},"2025-05-02",{"date":460,"type":31},"2022-03-10",{"date":462,"type":22},"2026-12-31",{"name":37,"class":38},{"id":465,"slug":466,"hasResults":12,"nctId":467,"briefTitle":468,"officialTitle":469,"acronym":470,"eligibilityCriteria":471,"healthyVolunteers":12,"sex":201,"minAge":19,"maxAge":4,"enrollmentInfo":472,"targetDuration":4,"studyType":170,"phases":474,"briefSummary":475,"conditions":476,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":478,"lastUpdatePostDateStruct":479,"startDateStruct":481,"completionDateStruct":483,"leadSponsor":485,"locationsCount":118},"100561785","phase-1-a-study-of-niraparib-in-combination-with-abemaciclib-for-late-line-treatment-of-ovarian-cancer-nichol-trial-100561785","NCT06594679","A Study of Niraparib in Combination With Abemaciclib for Late Line Treatment of Ovarian Cancer (NICHOL TRIAL)","A Study of Niraparib in Combination With Abemaciclib for Late Line Treatment of Ovarian Cancer: a Single Center, Open Label, Single Arm, Phase Ib\u002FII Trial NICHOL TRIAL","NICHOL","Inclusion Criteria:\n\n* Has read and understands the informed consent form and has given written informed consent prior to any study procedures.\n* Age \\> 18 years\n* Life expectancy of at least 3 months\n* Histologically confirmed epithelial ovarian, primary peritoneal, or fallopian tube cancer\n* Confirmed recurrent epithelial ovarian, primary peritoneal, or fallopian tube cancer for which there is no known or established treatment available with curative intent.\n* Able to provide archived tumor tissue;(formalin fixed-paraffin embedded (FFPE) tumor sample or a minimum of 20 unstained slides is required for study eligibility.\n\nNOTE: if archived tissue is not available, patient must be willing to undergo a tumor biopsy at screening if medically feasible.\n\n* Patients must have completed at least 2 previous chemotherapy regimens for platinum sensitive disease (\\> 6 months). Patients must have completed their last therapy regimen \\> 4 weeks prior to treatment initiation and have radiological confirm of progression disease.\n* Patients could have received maintenance therapy with a PARPi, but they must remain sensitive to platinum-based chemotherapy, based on the radiological or CA-125 response to their most recent course of platinum-based chemotherapy (carboplatin, cisplatin or oxaliplatin) or have demonstrated progressive disease while taking a PARP inhibitor as a previous therapy. Response to prior PARP inhibitor is not required.\n* Prior PARP therapy could have been administered as either treatment for recurrent disease or as maintenance following prior treatment.\n* Patients must have or agree to undergo tumor HRD testing and somatic BRCAmut status testing at screening.\n* Patients must agree to undergo blood samples during screening and at the end of treatment for cytogenetic analysis.\n* Phase 2 patients only: presence of measurable disease according to RECIST v1.1 criteria as assessed locally by Investigators.\n* Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0-1.\n* Absolute neutrophil count (ANC) ≥ 1500\u002FL (within 14 days of study drugs initiation).\n* Hemoglobin (Hgb) \\> 9 g\u002FdL with no blood transfusion in the past 14 days (within 14 days of study drug\\[s\\] initiation).\n* Platelets \\> 100,000\u002FL (within 14 days of study drug\\[s\\] initiation) with no platelets transfusion in the past 14 days.\n* Alanine transaminase (ALT) and aspartate transaminase (AST) ≤ 2.5 x upper limit of normal (ULN) or ≤ 5 x ULN if known hepatic metastases (within 14 days of study drugs initiation).\n* Serum bilirubin within normal limits (WNL) or ≤ 1.5 x ULN in patients with liver metastases; or total bilirubin ≤ 2.0 x ULN with direct bilirubin WNL in patients with well documented Gilbert's syndrome (within 14 days of study drugs initiation).\n* Patients should have calculated or measured creatinine clearance of ≥ 50 mL\u002Fmin according to Cockroft-Gault.\n* Willingness and ability to comply with study and follow-up procedures.\n* Women of child-bearing potential must have a negative pregnancy test (serum) within 3 days prior to starting the study drug. Both males and females must agree to adequate birth control if conception is possible during the study and for 6 months after the last dose; in this case, patients must take a monthly pregnancy test for the duration of the study. Female patients are considered to not be of child-bearing potential if they have a history of tubal ligation or hysterectomy or are post-menopausal with a minimum of 1 year without menses.\n\nThe methods that can achieve a failure rate of less than 1% per year when used consistently and correctly are considered as highly effective birth control methods. Such methods include:\n\n* combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation:\n\n  * oral;\n  * intravaginal;\n  * transdermal\n* progestogen-only hormonal contraception associated with inhibition of ovulation:\n\n  * oral;\n  * injectable;\n  * implantable.\n* intrauterine device (IUD);\n* intrauterine hormone-releasing system (IUS);\n* bilateral tubal occlusion;\n* vasectomised partner;\n* sexual abstinence.\n\nAdditional inclusion criteria:\n\n\\- Patients must agree to not donate blood during the study or for 90 days after the last dose of study treatment.\n\nExclusion Criteria:\n\n* Any other prior therapy directed at the malignant tumor, including immunologic agents administered within 4 weeks prior to first dose of study drug\n* Major surgical procedures ≤ 28 days of beginning study treatment, or minor surgical procedures \\\u003C 7 days. No timeline window required for port-a-cath placement.\n* Patients who received radiotherapy must have completed and fully recovered from the acute effects of radiotherapy. A washout period of at least 14 days is required between end of radiotherapy and randomization.\n* History of any ≥ grade 3 hematological toxicity due to prior chemotherapy that persisted for more than 4 weeks.\n* Patient has uncontrolled hypertension according to CTCAE v. 5.0\n* Grade \\> 1 toxicity from prior therapy (except alopecia or anorexia) that contraindicates start of new treatment.\n* Patient has inability to swallow oral medications or patients with gastrointestinal disorders likely to interfere with absorption of the study medication. Note: Patient may not have a percutaneous endoscopic gastrostomy (PEG) tube or be receiving total parenteral nutrition (TPN).\n* Known central nervous system (CNS) disease other than neurologically stable, treated brain metastases - defined as metastasis having no evidence of progression or hemorrhage for at least 28 days after treatment (including brain radiotherapy). Must be off any systemic corticosteroids for the treatment of brain metastases for at least 14 days prior to enrollment.\n* Chronic assumption of drugs or other products with a narrow therapeutic index and known to be CYP3A4 substrates, or drugs or other products known to be moderate to strong inhibitors\u002Finducers of CYP3A4 which cannot be discontinued 2 weeks prior to day -3 of dosing and withheld throughout the study until 2 weeks after the last dose of study drug. Co-administration of aprepitant or fosaprepitant during this study is prohibited.\n* Herbal preparations are not allowed throughout the study. These herbal medications include but are not limited to: St. John's wort, kava, ephedra (mahung), gingko biloba, dehydroepiandrosterone (DHEA), yohimbe, saw palmetto and ginseng, grapefruit and seville orange. Patients should stop using these herbal medications at least 7 days prior to first dose of study treatment.\n* Any known hypersensitivity or contraindication to the components of the study drugs.\n* Any of the following cardiac diseases currently or within the last 6 months: a. Unstable angina pectoris; b. Congestive heart failure; c. Acute myocardial infarction; d. Conduction abnormality not controlled with pacemaker or medication; e. Significant ventricular or supraventricular arrhythmias (patients with chronic rate- controlled atrial fibrillation in the absence of other cardiac abnormalities are eligible).\n* The patient has a personal history of any of the following conditions: syncope of cardiovascular etiology, ventricular arrhythmia of pathological origin (including, but not limited to, ventricular tachycardia and ventricular fibrillation), or sudden cardiac arrest.\n* Evidence of corrected QT interval (specifically QTc calculated using the Fridericia formula \\[QTcF\\]) \\> 470 msec from a single electrocardiogram (ECG) performed at study entry or congenital or acquired long QT syndrome.\n* The patient has serious and\u002For uncontrolled preexisting medical condition(s) that, in the judgment of the investigator, would preclude participation in this study (for example, interstitial lung disease, severe dyspnea at rest or requiring oxygen therapy, severe renal impairment \\[e.g. estimated creatinine clearance \\\u003C30ml\u002Fmin\\], history of major surgical resection involving the stomach or small bowel, or preexisting Crohn's disease or ulcerative colitis or a preexisting chronic condition resulting in baseline Grade 2 or higher diarrhea).\n* Pregnant or breast-feeding. Female patients should not breastfeed or store milk within 30 days of receiving the final dose of niraparib and abemaciclib.\n* Serious active infection at the time of study entry, or another serious underlying medical condition that would impair the ability of the patient to receive study treatment.\n* Presence of other active invasive cancers (except for definitively treated in-situ carcinomas \\[e.g. breast, cervix, bladder, skin melanoma\\], or basal or squamous cell carcinoma of the skin) within the past 24 months.\n* Psychological, familial, sociological, or geographical conditions that do not permit compliance with protocol.\n* Patients with myelodysplastic syndrome (MDS)\u002Facute myeloid leukemia (AML) or with features suggestive of MDS\u002FAML.\n* Previous allogenic bone marrow transplant or double umbilical cord blood transplantation (dUCBT).\n* History of human immunodeficiency virus (HIV) infection.\n* History Active HBV or HCV infection. Patients whose disease is controlled under antiviral therapy are eligible. Testing for HBV or HCV is not necessary unless clinically indicated.\n* History of cerebrovascular accident, PRES (posterior reversible encephalopathy syndrome), pulmonary embolism or untreated deep venous thrombosis (DVT) within the past 6 months.\n* The patient has received an experimental treatment in a clinical trial within the last 30 days or 5 half-lives, whichever is longer, prior to randomization, or is currently enrolled in any other type of medical research (for example: medical device) judged by the sponsor not to be scientifically or medically compatible with this study.\n* Pregnant or breast-feeding. Female patients should not breastfeed or store milk during the study treatment and within 30 days of receiving the final dose of niraparib and abemaciclib.",{"count":473,"type":22},73,[172,173],"This is an interventional trial. The goal of this clinical trial is dose finding. There are two phases: phase Ib to determine the MTD and recommended phase II dose of niraparib in combination with abemaciclib in patients with advanced ovarian cancer.\n\nTarget population will be patients (woman, age \\> 18 years) with epithelial ovarian, fallopian tube or peritoneal cancer treated with at least 2 lines of therapy.",[477],"Ovarian Cancer","2025-03-25",{"date":480,"type":31},"2025-03-28",{"date":482,"type":31},"2024-09-26",{"date":484,"type":22},"2027-09-18",{"name":37,"class":38},{"id":487,"slug":488,"hasResults":12,"nctId":489,"briefTitle":490,"officialTitle":491,"acronym":492,"eligibilityCriteria":493,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":396,"enrollmentInfo":494,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":496,"conditions":497,"keywords":499,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":501,"lastUpdatePostDateStruct":502,"startDateStruct":504,"completionDateStruct":506,"leadSponsor":507,"locationsCount":118},"100582409","liver-transplantation-for-unresectable-intrahepatic-colangiocarcinoma-after-sustained-response-to-neoadjuvant-treatments-100582409","NCT06862934","Liver Transplantation for Unresectable Intrahepatic Colangiocarcinoma After Sustained Response to Neoadjuvant Treatments","Liver Transplantation for Unresectable Intrahepatic Colangiocarcinoma After Sustained Response to Neoadjuvant Treatments (iCOLA)","iCOLA","Inclusion Criteria:\n\n* Histological diagnosis of iCCA (biopsy-proven tumor)\n* Either first diagnosis or post-resection recurrence (occurring ≥ 6 months after resection)\n* Unresectability assessment due to tumor location (leading to insufficient live remnant with\u002Fout implementation of hypertrophic parenchymal techniques) or underlying liver disease. Non-resectability assessed by an expert surgical team with experience on both resection and transplantation (centralized at INT Milan).\n* Age between 18 and 70 years\n* No macrovascular tumor invasion (NB: portal vein and\u002For hepatic vein occlusion from the external tumor compression and classified as \"encasement\" could be considered after expert radiology review)\n* No extrahepatic spread\n* Disease stability for at least 6 months\n* CA 19-9 \\\u003C 200 u\u002Fml at transplant listing in absence of jaundice\n* No medical and surgical contraindications to liver transplantation\n* Good performance status, Eastern Cooperative Oncology Group (ECOG) 0 or 1\n* No concomitant malignancies or history of other malignancies in the previous 5 years\n* Written informed consent\n\nExclusion Criteria:\n\n* Hilar and distal cholangiocarcinoma\n* Progression of disease under chemotherapy +\u002F- radiation therapy, assessed with either RECIST, mRECIST or Choi criteria\n* Evidence of lymph-nodal metastases\n* Evidence of extrahepatic disease\n* Prior extrahepatic metastatic disease\n* Concomitant malignancies or history of other malignancies in the previous 5 years\n* Substance abuse, medical, psychological, or social conditions that may interfere with the patient's participation in the study or evaluation of the study results\n* Any reason why, in the opinion of the investigator, the patient should not participate to the study",{"count":495,"type":22},14,"This is single-arm, observational, academic, investigator-driven study investigating the efficacy of liver transplantation after successful and sustained downstaging\u002Ftumor control of liver-limited unresectable intrahepatic cholangiocarcinoma. The downstaging protocol includes chemotherapy +\u002F- immunotherapy and transarterial radioembolization (TARE) with Yttrium-90 in various combinations.",[498],"Intrahepatic Cholangiocarcinoma (Icc)",[403,500,405],"transarterial radioembolization","2025-03-03",{"date":503,"type":31},"2025-03-06",{"date":505,"type":22},"2025-03-20",{"date":35,"type":22},{"name":37,"class":38},{"id":509,"slug":510,"hasResults":12,"nctId":511,"briefTitle":512,"officialTitle":513,"acronym":514,"eligibilityCriteria":515,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":516,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":518,"conditions":519,"keywords":556,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":562,"lastUpdatePostDateStruct":563,"startDateStruct":565,"completionDateStruct":567,"leadSponsor":569,"locationsCount":570},"100578016","predicting-clinical-outcomes-during-first-line-cdk46-inhibitors-plus-endocrine-therapy-in-patients-with-advanced-hormone-receptor-positive-her2-negative-breast-cancer-the-retrospective-prospective-multicenter-italian-palmares-2-study-100578016","NCT06805812","Predicting clinicAL outcoMes During First-line CDK4\u002F6 Inhibitors Plus Endocrine Therapy in Patients With Advanced Hormone REceptor-poSitive HER2-negative Breast Cancer: the Retrospective-prospective Multicenter Italian PALMARES-2 Study","Predictive Impact of Peripheral Blood Lymphocytes on clinicAL outcoMes During First-line CDK4\u002F6 Inhibitors Plus Endocrine Therapy in Patients With Advanced Hormone REceptor-poSitive HER2-negative Breast Cancer: the Retrospective-prospective Multicenter Italian PALMARES-2 Study","PALMARES-2","Inclusion Criteria:\n\n* Diagnosis of HR+\u002FHER2- advanced Breast Cancer (aBC), as defined as at least 1% estrogen receptor (ER) and\u002For progesterone receptor (PgR) positivity at IHC. HER2 negativity is defined on the basis of an IHC score of 0, 1+, or 2+ with absence of gene amplification at in situ hybridization (ISH) analyses.\n* Have received or are candidate to receive treatment with palbociclib, ribociclib or abemaciclib in combination with endocrine therapy as first-line treatment for HR+\u002FHER2- aBC.\n\nExclusion Criteria:\n\n* Less than 3 months of follow up from the CDK4\u002F6i start to the date of data cut-off;\n* Have received CDK4\u002F6i as monotherapy;\n* Have received CDK4\u002F6i as adjuvant treatment for localized disease.",{"count":517,"type":22},3500,"PALMARES-2 is a retrospective\u002Fprospective, observational, multicenter, population-based study, aiming at providing real-world evidences on HR+\u002FHER2- aBC patients treated with first-line CDK4\u002F6i plus ET. The present study has the objective to collect data coming from different sources, i.e. RWD, medical images and biological samples, from patients treated with CDK4\u002F6i as first-line of therapy for HR+\u002FHER2- aBC. In consideration of the complexity of data collected and different objectives of the study, this master protocol foresees different sub-studies, which encompasses different methodologies for data collection, data extraction and analyses.",[520,339,521,340,522,341,523,342,344,524,525,526,527,528,529,530,531,532,533,534,535,536,537,538,539,540,541,542,543,544,545,546,547,548,549,550,551,552,553,554,555],"Breast Adenocarcinoma","Breast Cancer, Metastatic","Breast Diseases","Breast Neoplasms, Male","Breast Cancers","Breast Neoplasm","Breast Tumors","HR+ HER2- Men, Pre\u002FPostmenopausal Advanced Breast Cancer","HR+ Advanced or Metastatic Breast Cancer","HR+\u002FHER2- Breast Cancer","HRpos Breast Neoplasms","HR-positive, HER2-negative Advanced Breast Cancer","HR-positive, HER2-negative and PIK3CA Mutation Advanced Breast Cancer","HR-positive Breast Cancer","Hormone Receptor-Positive Breast Cancer","Hormone Receptor Positive Breast Adenocarcinoma","Hormone Receptor Positive Breast Carcinoma","Hormone Receptor Positive Breast Neoplasms","Hormone Receptor Positive HER-2 Negative Breast Cancer","Hormone Receptor Positive Malignant Neoplasm of Breast","Hormone Receptor Positive Metastatic Breast Cancer","Hormone Receptor Positive, HER2 Negative Breast Cancer","Hormone Receptor Negative Breast Cancer","Hormone Receptor Positive, HER2-negative, Advanced Breast Cancer","Hormone Receptor Positive Breast Cancer","Hormone Receptor Positive (ER+\u002FPR+, and Her2-) Metastatic Breast Cancer","Hormone Receptor Positive, HER2-negative Neoplasms","Hormone Receptor Positive, HER2-low Neoplasms","Hormone Receptor Positive (HR+), HER2-negative Breast Cancer","Hormone Receptor (HR)-Positive Breast Cancer","Hormone Receptor-Positive, HER2-Negative Metastatic Breast Cancer","Palbociclib","Ribociclib","Abemaciclib","CDK4\u002F6 Inhibitor","CDK4\u002F6 Inhibitors",[557,558,551,552,553,559,560,561],"HR+\u002FHER2- Advanced Breast Cancer","HR+\u002FHER2- Metastatic Breast Cancer","CDK4\u002F6i","Cyclin-Dependent Kinase 4\u002F6 inhibitors","Metastatic Breast Cancer","2025-01-28",{"date":564,"type":31},"2025-02-03",{"date":566,"type":31},"2023-05-01",{"date":568,"type":22},"2040-12-31",{"name":37,"class":38},24,{"id":572,"slug":573,"hasResults":12,"nctId":574,"briefTitle":575,"officialTitle":576,"acronym":577,"eligibilityCriteria":578,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":579,"enrollmentInfo":580,"targetDuration":4,"studyType":170,"phases":582,"briefSummary":583,"conditions":584,"keywords":586,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":594,"lastUpdatePostDateStruct":595,"startDateStruct":597,"completionDateStruct":599,"leadSponsor":601,"locationsCount":118},"100577599","phase-2-metronomic-neoadjuvant-capecitabine-and-cyclophosphamide-in-huge-pseudomyxoma-peritonei-patients-100577599","NCT06800391","Metronomic Neoadjuvant Capecitabine and Cyclophosphamide in HUGE Pseudomyxoma Peritonei Patients","Metronomic Neoadjuvant Capecitabine and Cyclophosphamide in Huge (PCI>28) Pseudomyxoma Peritonei Patients Candidates to Cytoreductive Surgery (CRS) and Hypertermic Intraperitoneal Chemotherapy (HIPEC)","REVERSE","Inclusion Criteria:\n\n* Clinical\u002FHistological diagnosis of pseudomyxoma peritonei (PMP);\n* Peritoneal Cancer Index (PCI \\>28) assessed by chest and abdominal CT scan at the staging phase;\n* Age \\>= 18 years and \\\u003C76 years;\n* Performance Status (ECOG \\\u003C2);\n* Adequate organ function including the following:\n* Adequate bone marrow reserve: WBC count \\>3.0x109\u002FL, absolute neutrophyl count \\>1.5x109\u002FL, platelet count \\>100x109\u002FL, and hemoglobin \\>10 g\u002FdL;\n* Hepatic: bilirubin \\\u003C 1.5 times the ULN, alkaline phosphatase, aspartate transaminase, and alanine transaminase \\\u003C 2.5 x UL;\n* Renal: Creatinine clearance \\>50 mL\u002Fmin or serum creatinine \\\u003C1.5 x UNL;\n* Patients compliance and geographic proximity that allows for adequate follow-up;\n* Patients must sign an informed consent document (ICD);\n* Male and female patients with reproductive potential must use an approved contraceptive method;\n\nExclusion Criteria:\n\n* Peritoneal Cancer Index (PCI ≤28) assessed by chest and abdominal CT scan at the staging phase;\n* DPD deficiency;\n* Previous systemic chemotherapy and\u002For biological therapy;\n* Administration of other experimental drugs during the study Pregnancy and breast-feeding;\n* Serious or uncontrolled medical pathologies or active infections that would jeopardize the possibility of receiving the investigated treatment;\n* Disorders that could influence the absorption of capecitabine (e.g. malabsorption), intestinal occlusion, Crohn's disease or ulcerative colitis;\n* Psychiatric disorders, neurologic disease or other conditions that would make it impossible to comply with the protocol procedures;\n* Positive anamnesis with regard to other neoplastic diseases except for the ones that have been cured for more than 5 years.","76 Years",{"count":581,"type":22},31,[173],"The goal of this clinical trial is to evaluate the safety and efficacy of neoadjuvant capecitabine and cyclophosphamide treatment in patients affected by huge Pseudomyxoma peritonei (PMP) (peritoneal cancer index \\>28). Treatment consists of metronomic (low-dose medication for a prolonged time) of capecitabine plus cyclophosphamide for 6 months followed by standard of care cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC). The main question the trial aims to answer is which is the proportion of patients with complete cytoreduction at CRS\u002FHIPEC after neoadjuvant metronomic approach with oral capecitabine and cyclophosphamide in patients affected by huge PMP.",[585],"Pseudomyxoma Peritonei",[587,588,589,590,591,592,593],"Pseudomyxoma peritonei","metronomic regimen","capecitabine","cyclophosphamide","cytoreductive surgery","HIPEC","peritoneal cancer index","2025-01-23",{"date":596,"type":31},"2025-01-30",{"date":598,"type":31},"2024-11-22",{"date":600,"type":22},"2029-11",{"name":37,"class":38},{"id":603,"slug":604,"hasResults":12,"nctId":605,"briefTitle":606,"officialTitle":606,"acronym":607,"eligibilityCriteria":608,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":609,"targetDuration":611,"studyType":23,"phases":4,"briefSummary":612,"conditions":613,"keywords":615,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":620,"lastUpdatePostDateStruct":621,"startDateStruct":623,"completionDateStruct":625,"leadSponsor":627,"locationsCount":39},"100574722","a-composite-assay-for-her2-positive-early-stage-breast-cancer-management-100574722","NCT06762977","A Composite Assay for HER2-positive Early-stage Breast Cancer Management","HERCard","Inclusion Criteria:\n\n1. Age ≥ 18 years\n2. Operable breast cancer (stage I-III)\n3. Any status of hormone receptor in the primary tumor, according to institutional guidelines\n4. HER2-positive primary tumor, according to ASCO guidelines, i.e., HER2-positive phenotype by immunohistochemistry (IHC) 3+ or 2+ with a positive result for ERBB2 gene amplification analysis using ISH techniques (CISH, SISH, FISH)\n5. Neoadjuvant and\u002For adjuvant therapy based on trastuzumab ± pertuzumab\n6. Written informed consent from patients\n\nExclusion Criteria:\n\n1. Patient in follow-up for less than 3 years after surgery\n2. A prior diagnosis of invasive cancer before the diagnosis of breast cancer",{"count":610,"type":22},180,"3 Years","The goal of this observational study is to assess the prognostic value of a genomic classifier (S18) and its refined version (S\\*) in women with early-stage HER2-positive breast cancer. The study aims to determine whether these tools can predict event-free (EFS) and disease-free survival (DFS) in patients treated with neoadjuvant and\u002For adjuvant trastuzumab-based therapies.",[614,346],"Breast Cancer Early Stage Breast Cancer (Stage 1-3)",[616,617,618,619],"HER2-positive","operable breast cancer","gene-expression based classifier","prognosis","2025-01-07",{"date":622,"type":31},"2025-01-08",{"date":624,"type":31},"2024-11-13",{"date":626,"type":22},"2026-08",{"name":37,"class":38},{"id":629,"slug":630,"hasResults":12,"nctId":631,"briefTitle":632,"officialTitle":632,"acronym":633,"eligibilityCriteria":634,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":635,"targetDuration":4,"studyType":170,"phases":636,"briefSummary":637,"conditions":638,"keywords":644,"overallStatus":211,"whyStopped":4,"lastUpdateSubmitDate":647,"lastUpdatePostDateStruct":648,"startDateStruct":650,"completionDateStruct":652,"leadSponsor":654,"locationsCount":4},"100573852","xpert-bladder-monitor-a-non-invasive-follow-up-tool-for-detecting-relapse-in-high-grade-or-high-risk-bladder-cancer-100573852","NCT06751667","Xpert Bladder Monitor: a Non-Invasive Follow-Up Tool for Detecting Relapse in High Grade or High Risk Bladder Cancer","LIBERO","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Has a legally acceptable representative capable of understanding the informed consent document and providing consent on the participant's behalf\n* NMIBC high grade or high risk (already subjected to or currently undergoing treatment with BCG).\n* No contraindications to surgery\n\nExclusion Criteria:\n\n* Inability or unwillingness of the participant or their legal representative to provide written informed consent\n* Absolute contraindications to surgery or cystoscopy\n* Patients who have previously participated in clinical protocols involving chemotherapy drugs or immunotherapy\n* Patients with multiple recurrent tumors eligible for cystectomy or Muscle-Invasive Bladder Cancer (MIBC)",{"count":127,"type":22},[313],"Main objectives:\n\nQualitative and quantitative monitoring of recurrences in patients with a previous diagnosis of high-grade bladder cancer at high risk of persistence\u002Frecurrence.\n\nEndpoints: Presence or absence of mRNA in urine with a dichotomous result; concordance between Xpert BM and histopathological examination\n\nClinical relevance: reduces by half the number of (invasive) cystoscopies during follow-up. The non-invasive nature of the test could improve patient compliance with follow-up. Interventional study because it would reduce by half the number of cystoscopies during follow-up of bladder cancer which is considered the gold standard in the follow-up of this tumor. However, these markers are already CE validated and described in the European guidelines and for this reason the risk would be low.",[639,640,641,642,643],"Bladder (Urothelial, Transitional Cell) Cancer","Bladder Cancer","Bladder Tumors","Bladder Cancer Recurrence","Cystoscopy",[645,646],"Xpert Bladder Monitor","Gene Xpert","2024-12-20",{"date":649,"type":31},"2024-12-30",{"date":651,"type":22},"2025-01-01",{"date":653,"type":22},"2032-01-01",{"name":37,"class":38},{"id":656,"slug":657,"hasResults":12,"nctId":658,"briefTitle":659,"officialTitle":660,"acronym":661,"eligibilityCriteria":662,"healthyVolunteers":12,"sex":201,"minAge":19,"maxAge":4,"enrollmentInfo":663,"targetDuration":4,"studyType":170,"phases":665,"briefSummary":667,"conditions":668,"keywords":670,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":676,"lastUpdatePostDateStruct":677,"startDateStruct":679,"completionDateStruct":681,"leadSponsor":683,"locationsCount":159},"100571902","phase-4-akynzeo-as-antiemetic-treatment-in-patients-with-endometrial-cancer-100571902","NCT06726291","Akynzeo as Antiemetic Treatment in Patients With Endometrial Cancer","Akynzeo as Antiemetic Treatment in Patients With Endometrial Cancer Treated With Taxane- Platinum Combination Chemotherapy. NOEME Study.","NOEME","Inclusion Criteria:\n\n* Subject is at least 18 years of age, able to understand the study procedures, and agrees to participate in the study by providing written informed consent\n* Subject has histologically or cytologically proven endometrial cancer\n* Patients were required to have an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2\n* Adequate organ function allowing the patient to receive taxane-platinum combination therapy with or without immunotherapy according to clinical practice and opinion of treating physician\n* Naive to chemotherapy\n* Women of child-bearing potential must have a negative pregnancy test (urine). Female patients are considered of child-bearing potential following menarche and until becoming post-menopausal unless permanently sterile. Permanent sterilization methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy. Patients are considered to not be of child-bearing potential if they have a history of tubal ligation or hysterectomy or are post-menopausal with a minimum of 1 year without menses. Patients of child-bearing potential must agree to adequate birth control if conception is possible during the study and for 6 months after the last dose; in this case, patients must take a monthly pregnancy test for the duration of the study\n\nExclusion Criteria:\n\n* They will experience emesis within the 24 hours before receipt of 1 course of chemotherapy\n* will be scheduled to radiation therapy to the abdomen or pelvis within 1 week before day 1 or between day 1 and 5\n* Will be scheduled to undergo bone marrow or stem-cell transplant\n* Chronic systemic corticosteroid use\n* Brain metastasis\n* Subject is considered a poor medical risk due to a serious, uncontrolled medical disorder\n* History or predisposition to cardiac conduction abnormalities, torsade des pointes or severe cardiovascular diseases\n* Subject is pregnant or breastfeeding or is expecting to conceive children within the projected duration of the study, starting with the screening visit through 180 days after the last dose of study treatment\n* They have any known hypersensitivity or contraindication to the components of the study drugs (hypersensitivity to the active substance or to any of the excipients contained in the product, as listed in the relevant section of the summary of product characteristics)",{"count":664,"type":22},84,[666],"PHASE4","The clinical trial concerns the use of an innovative \\"anti-emetic\\" drug (that is, anti-vomiting and nausea) in subjects affected by endometrial cancer. It is addressed to patients who have never received chemotherapy before and are about to start a treatment with platinum and taxanes with or without immunotherapy for endometrial cancer.\n\nThe primary objective of the study is to learn if the drug is able to avoid the occurrence of vomiting and post- nausea chemotherapy within 120 hours after cycle 1 with carboplatin and paclitaxel with or without immunotherapy.\n\nPartecipants will take the drug before the chemotherapy\u002Fimmunotherapy (single dose at day one of each cycle of therapy, that is one capsule before treatment). The entire duration of participation in the study may extend to the fourth cycle of chemotherapy\u002Fimmunotherapy.\n\nPatients will fill in questionnaires and keep a diary of the number and intensity of symptoms (vomiting and nausea).",[669],"Endometrial Cancer",[671,672,673,674,675],"antiemetic","nausea","vomiting","chemotherapy side effects","netupitant\u002Fpalonosetron","2024-12-05",{"date":678,"type":31},"2024-12-10",{"date":680,"type":31},"2024-02-26",{"date":682,"type":22},"2026-06-30",{"name":37,"class":38},{"id":685,"slug":686,"hasResults":12,"nctId":687,"briefTitle":688,"officialTitle":689,"acronym":690,"eligibilityCriteria":691,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":692,"targetDuration":4,"studyType":170,"phases":694,"briefSummary":696,"conditions":697,"keywords":699,"overallStatus":211,"whyStopped":4,"lastUpdateSubmitDate":705,"lastUpdatePostDateStruct":706,"startDateStruct":708,"completionDateStruct":710,"leadSponsor":712,"locationsCount":39},"100553000","phase-3-high-versus-lower-intensity-surveillance-following-resection-of-retroperitoneal-sarcoma-100553000","NCT06480396","High Versus Lower Intensity Surveillance Following Resection of Retroperitoneal Sarcoma","An International, Partially-randomised, Patient-preference Trial Within a Registry of High Versus Lower Intensity Radiological Surveillance Following Primary Resection of Retroperitoneal, Abdominal and Pelvic Soft Tissue Sarcoma","SARveillance","Inclusion Criteria:\n\n* Adult patients (greater than 18 years)\n* Primary resection\n* Histologically confirmed retroperitoneal, abdominal or pelvic soft tissue sarcoma\n* R0\u002FR1 resection\n* Eligible whether or not the participant undergoes neoadjuvant treatment\n\nExclusion Criteria:\n\n* Metastatic disease at time of randomisation\n* Recurrent, metastatic or residual disease identified on baseline CT imaging (3-4 months post primary resection)\n* Reoperation for recurrent soft tissue sarcoma\n* Re-resection following previous inadequate surgery\n* R2 resection\n* Patients receiving adjuvant therapy that will delay, interrupt or render radiological surveillance unpredictable\n* Uterine sarcomas, gastrointestinal stromal tumour (GIST), fibromatosis, epithelial tumours, multifocal disease, sarcomas of bony origin\n* Patient declined to consent to data sharing with RESAR (unless in a centre contributing via pre-planned IPDMA)",{"count":693,"type":22},584,[695],"PHASE3","The SARveillance trial is an efficient, pragmatic, multi-centre, international, stratified, partially-randomised, patient-preference trial within a registry of high versus lower intensity radiological surveillance following primary resection of retroperitoneal, abdominal and pelvic soft tissue sarcoma. The trial design is stratified by sarcoma tumour grade (high\u002Fintermediate grade and low grade).",[54,698],"Sarcoma Retroperitoneal",[700,701,702,703,704],"Surveillance","Radiology","Surgery","Quality of life","Cost-effectiveness","2024-10-14",{"date":707,"type":31},"2024-10-16",{"date":709,"type":22},"2024-11",{"date":711,"type":22},"2033-12",{"name":37,"class":38},""]