[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"European Institute of Oncology\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":585},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,71,0,25,[9,43,68,92,123,147,169,196,217,240,264,283,300,318,336,364,391,413,435,458,477,499,521,541,564],{"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":27,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100644576","patient-anxiety-during-magnetic-resonance-imaging-100644576",false,"NCT07671846","Patient Anxiety During Magnetic Resonance Imaging","Italian Translation and Cross-cultural Validation of a Questionnaire Evaluating Patient Anxiety During Magnetic Resonance Imaging: the Magnetic Resonance Imaging-Anxiety Questionnaire (MRI-AQ)","MRI-AQ","Inclusion Criteria:\n\n* Cancer patients who will perform a WB-MRI in their clinical path\n* Age ≥ 18 years\n* Patients able to speak and read the local language(s) fluently.\n* Patients with no concomitant neurological or psychiatric disorders.\n* Acceptance and signature of informed consent\n\nExclusion Criteria:\n\n* Absolute contraindication to WB-MRI\n* Previous cancer-related medical treatments or other treatments that could have altered patients' cognition","ALL","18 Years",{"count":21,"type":22},175,"ESTIMATED","OBSERVATIONAL","This study is a cross-sectional validation project that aims to translate the MRI-Anxiety Questionnaire (MRI-AQ) into Italian and adapt it culturally for cancer patients undergoing whole-body MRI. The protocol will recruit 175 adult patients at the European Institute of Oncology, use a forward-backward translation process, and evaluate the Italian version with the MRI-AQ itself plus the MRI Fear Survey Schedule (MRI-FSS). The main statistical goal is to show that the Italian version is not inferior to the original in terms of internal consistency. The ultimate purpose is to provide a specific, validated tool for measuring MRI-related anxiety in Italian oncology patients.",[26],"Cancer",[28,29],"Magnetic Resonance Imaging","Patient anxiety","RECRUITING","2026-06-25",{"date":33,"type":34},"2026-06-26","ACTUAL",{"date":36,"type":34},"2026-05-06",{"date":38,"type":22},"2027-02-28",{"name":40,"class":41},"European Institute of Oncology","OTHER",1,{"id":44,"slug":45,"hasResults":12,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":49,"eligibilityCriteria":50,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":51,"enrollmentInfo":52,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":54,"conditions":55,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":67},"100614371","upfront-targeted-axillary-dissection-for-luminal-breast-cancer-with-limited-axillary-involvement-100614371","NCT07278726","Upfront Targeted Axillary Dissection for Luminal Breast Cancer With Limited Axillary Involvement","Upfront Targeted Axillary Dissection for Luminal Breast Cancer With Limited Axillary Involvement: the UTAD Study of the Italian National Association of Breast Surgeons (ANISC)","UTAD","Inclusion Criteria:\n\n* Diagnosis of T0-T1-T2 ER+\u002FPR+ HER2- breast cancer with limited nodal involvement (1 or 2 suspicious lymph node on US, with at least 1 nodal positive cytology\u002Fhistology)\n* M0\n* Conservative surgery or mastectomy\n* Neoadjuvant treatment not recommended after a multidisciplinary discussion\n* Patients between 18 and 90 years old\n* Patients willing and able to follow the study procedures and available for follow-up over the entire duration of the study\n\nExclusion Criteria:\n\n* Psychiatric, addictive or any disorder, which compromises ability to give informed consent for participation in the study\n* Personal history of invasive breast cancer\n* Other invasive malignancies diagnosed in the last five years\n* Any condition that may expose the individual to a higher risk or preclude the study from achieving full compliance or completion\n* Contraindications to radiation therapy","90 Years",{"count":53,"type":22},150,"The present study aims to avoid axillary lymph node dissection (ALND) in patients with an Ultrasound (US) detected positive preoperative lymph node involvement (1 or 2 suspicious lymph-nodes) and a needle histology\u002Fcytology placing a marker in the most suspicious node undergoing upfront surgery if neoadjuvant treatment is not indicated. The marked lymph node will be retrieved along with sentinel lymphnode(SLN)(s) to minimize the false-negative rate and only in case of ≥3 positive SLNs ALND will be performed, in order to minimize surgical overtreatment among women with preoperatively confirmed axillary nodal metastasis.",[56,57,58],"ALND","Sentinel Lymph Node Biopsy (SLNB)","Targeted Axillary Dissection (TAD)","2026-06-15",{"date":61,"type":34},"2026-06-16",{"date":63,"type":34},"2026-01-28",{"date":65,"type":22},"2033-11",{"name":40,"class":41},14,{"id":69,"slug":70,"hasResults":12,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":74,"eligibilityCriteria":75,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":76,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":78,"conditions":79,"keywords":81,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":84,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":91},"100592511","emotional-distress-in-patients-with-metastatic-breast-cancer-in-first-line-of-therapy-100592511","NCT06994377","Emotional Distress in Patients With Metastatic Breast Cancer in First Line of Therapy","The Impact of Emotional Distress on First Line Therapy in Patients With Metastatic Breast Cancer (EIRENE): a Prospective Observational Study","EIRENE","Inclusion Criteria:\n\n* Age over 18 years\n* Confirmed histological diagnosis of breast cancer\n* No prior treatment for advanced\u002Fmetastatic cancer\n* Indication to receive first-line therapy as per standard clinical practice based on the disease subtype:\n\n  1. cohort A (HR-\u002FHER2-, PD-L1+): pembrolizumab or atezolizumab + chemotherapy\n  2. cohort B (HR-\u002FHER2-, PD-L1-): chemotherapy\n  3. cohort C (HR+\u002FHER2-): CDK4\u002F6 inhibitor + endocrine therapy\n  4. cohort D (HER2+): chemotherapy + trastuzumab and pertuzumab\n* Presence of measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 and\u002For Positron Emission Tomography Response Criteria in Solid Tumors (PERCIST) criteria\n* Able to provide full informed consent for the study\n\nExclusion Criteria:\n\n* Pre-existing severe psychiatric disorders or other conditions that could impair the ability to provide informed consent\n* Inability to complete questionnaires\n* Presence of another malignancy in the previous 3 years\n* Symptomatic brain metastases\n* Ongoing treatment with antidepressant and\u002For anxiolytic drugs",{"count":77,"type":22},1000,"Few data about the impact of emotional distress (ED) on treatment efficacy in patients with metastatic breast cancer (mBC) are available.\n\nAim of this study is to assess the outcomes of patients with mBC receiving first-line treatment according to the presence of baseline ED.",[80],"Metastatic Breast Cancer",[80,82,83],"Emotional Distress","First Line Therapy",{"date":85,"type":34},"2026-06-17",{"date":87,"type":34},"2025-06-25",{"date":89,"type":22},"2029-06",{"name":40,"class":41},37,{"id":93,"slug":94,"hasResults":12,"nctId":95,"briefTitle":96,"officialTitle":97,"acronym":98,"eligibilityCriteria":99,"healthyVolunteers":100,"sex":101,"minAge":19,"maxAge":102,"enrollmentInfo":103,"targetDuration":4,"studyType":104,"phases":105,"briefSummary":107,"conditions":108,"keywords":111,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":115,"lastUpdatePostDateStruct":116,"startDateStruct":118,"completionDateStruct":120,"leadSponsor":122,"locationsCount":42},"100642536","dietary-quality-and-nutritional-adequacy-among-vegetarians-attending-the-european-institute-of-oncology-100642536","NCT07638839","Dietary Quality and Nutritional Adequacy Among Vegetarians Attending the European Institute of Oncology","Survey on Dietary Quality and Nutritional Adequacy Among Vegetarians Attending the European Institute of Oncology","VEGETARIANS","Inclusion Criteria:\n\n* pre or post-menopausal women, aged between 18 and 64;\n* healthy participants or high-risk cancer patients or patients with previous diagnosis of neoplasia\n* self-identifying as vegan (defined as excluding all animal products), or vegetarian (defined as excluding all animal products besides eggs and\u002For dairy) or semi-vegetarian (defined as excluding no animal products but limiting meat to \\\u003C 1× per week);\n* ability to understand and the willingness to sign a written informed consent document;\n\nExclusion Criteria:\n\n* any condition which, in the opinion of the investigator, may impede testing of the study hypothesis or make it unsafe to engage in the study (e.g., ulcerative colitis, Crohn's disease etc.);\n* any diagnosis of invasive neoplasia, within the previous 1 years, except non-melanoma skin cancer;\n* currently receiving chemotherapy, radiation, or immunotherapy as cancer treatment;\n* patients dependent on enteral or parental nutrition;\n* pregnancy or lactation;",true,"FEMALE","64 Years",{"count":53,"type":22},"INTERVENTIONAL",[106],"NA","Despite their health benefits, vegetarian dietary patterns can lead to malnutrition and micronutrient deficiencies if improperly managed, especially in oncological settings. This survey assesses dietary quality and adequacy in 150 women (18-64 years), further examining how a threemonth nutritional counseling intervention influences body composition, physical activity, and quality of life.",[109,110],"Nutritional Deficiencies","Quality of Life",[112,113,114],"vegan","vegetarian","semivegetarian diet","2026-06-09",{"date":117,"type":34},"2026-06-10",{"date":119,"type":34},"2026-03-26",{"date":121,"type":22},"2028-01-26",{"name":40,"class":41},{"id":124,"slug":125,"hasResults":12,"nctId":126,"briefTitle":127,"officialTitle":128,"acronym":129,"eligibilityCriteria":130,"healthyVolunteers":12,"sex":101,"minAge":19,"maxAge":4,"enrollmentInfo":131,"targetDuration":4,"studyType":104,"phases":133,"briefSummary":134,"conditions":135,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":139,"lastUpdatePostDateStruct":140,"startDateStruct":142,"completionDateStruct":144,"leadSponsor":146,"locationsCount":42},"100637699","endoscopic-video-assisted-nipple-sparing-mastectomy-100637699","NCT07579117","Endoscopic Video-Assisted Nipple-Sparing Mastectomy","EVA - Endoscopic Video-Assisted Nipple-Sparing Mastectomy (E-NSM): A Pilot Study","EVA","Inclusion Criteria:\n\n* Female patients aged ≥18 years\n* Candidates for nipple-sparing mastectomy (NSM) with immediate reconstruction\n* Histologically confirmed invasive carcinoma cT1N0, or carriers of pathogenic germline mutations undergoing prophylactic mastectomy\n* Breast size I-III and absence of significant glandular ptosis\n* Signed informed consent\n\nExclusion Criteria:\n\n* Inflammatory breast cancer\n* Locally advanced clinical stage (cT2-T4 or N+)\n* Ductal carcinoma in situ (DCIS) without invasive component\n* Previous radiotherapy to the affected breast\n* Locoregional recurrence\n* Clinical conditions contraindicating prosthetic reconstruction\n* Indication for skin-sparing (SSM) or skin-reducing mastectomy (SRM)\n* Ongoing or completed neoadjuvant chemotherapy before surgery\n* Refusal or inability to sign informed consent\n* Inability to complete scheduled follow-up",{"count":132,"type":22},10,[106],"Endoscopic video-assisted nipple-sparing mastectomy (E-NSM) is an advancement in minimally invasive breast surgery designed to reduce surgical trauma and improve cosmetic outcomes while maintaining strict oncologic safety. The procedure will be carried out by a dedicated surgical team in which at least one operator holds certified laparoscopic surgical training issued by a recognized scientific society, ensuring appropriate technical expertise and adherence to surgical safety standards.",[136,137,138],"Endoscopic Video-assisted Nipple-sparing Mastectomy","Breast Surgery","Breast Cancer","2026-05-28",{"date":141,"type":34},"2026-06-01",{"date":143,"type":34},"2026-05-23",{"date":145,"type":22},"2027-07",{"name":40,"class":41},{"id":148,"slug":149,"hasResults":12,"nctId":150,"briefTitle":151,"officialTitle":152,"acronym":153,"eligibilityCriteria":154,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":155,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":157,"conditions":158,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":139,"lastUpdatePostDateStruct":161,"startDateStruct":163,"completionDateStruct":165,"leadSponsor":167,"locationsCount":168},"100606833","breast-cancer-relapsed-in-patients-treated-with-adjuvant-cdk46-inhibitors-100606833","NCT07180693","Breast Cancer RElapsed in Patients Treated With Adjuvant CDK4\u002F6 Inhibitors:","Breast Cancer RElapsed in Patients Treated With Adjuvant CDK4\u002F6 Inhibitors: Evaluation in the Real-world Setting","BREAKER","Inclusion Criteria:\n\n* Female (regardless of menopausal status) or male ≥18 years of age;\n* The patient has confirmed HR+, HER2-, early-stage resected invasive breast cancer candidate to adjuvant CDK4\u002F6 inhibitors (abemaciclib or ribociclib);\n* ER and PgR positivity is defined as evidence of immunohistochemical staining ≥ 1% according to ASCO\u002FCAP recommendations; HER2 negativity is defined as expression of the membrane protein in immunohistochemistry 0 or 1+ or with a 2+ in situ hybridization (ISH) test negative as per ASCO\u002FCAP recommendations;\n* Patients who are initiating or have initiated adjuvant treatment with a CDK4\u002F6 inhibitor (abemaciclib or ribociclib) in combination with endocrine therapy (ET). Treatment must have started on or after January 1, 2021.\n* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2;\n* Consent to data treatment according to the local regulation.\n\nExclusion Criteria:\n\n* Current participation in any other HR+\u002FHER2- EBC study with any investigational products;\n* Patients who have already received adjuvant treatment with a CDK4\u002F6 inhibitor as part of a clinical trial;\n* Patients unable to comply with the requirements of the study or who, in the judge of the study physician, should not be included in the study;\n* Patients with a history of previous BC, with the exception of Ductal carcinoma in situ (DCIS) treated by locoregional therapy alone ≥5 years ago;\n* Patients with a history of any other cancer (except non-melanoma skin cancer or carcinoma in situ of the cervix), unless in complete remission with no therapy for a minimum of 5 years from the index date, will be excluded, as well.",{"count":156,"type":22},750,"This is a multicenter observational study with both retrospective and prospective phase, designed to evaluate the clinico-pathologic characteristics and outcomes of patients with HR+\u002FHER2- EBC at high risk of recurrence treated with ribociclib or abemaciclib in combination with ET in the adjuvant setting.",[159,160],"Adjuvant Therapy","CDK4\u002F6 Inhibitor",{"date":162,"type":34},"2026-05-29",{"date":164,"type":34},"2025-09-29",{"date":166,"type":22},"2030-08-01",{"name":40,"class":41},18,{"id":170,"slug":171,"hasResults":12,"nctId":172,"briefTitle":173,"officialTitle":174,"acronym":175,"eligibilityCriteria":176,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":177,"targetDuration":4,"studyType":104,"phases":179,"briefSummary":181,"conditions":182,"keywords":183,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":188,"lastUpdatePostDateStruct":189,"startDateStruct":191,"completionDateStruct":193,"leadSponsor":195,"locationsCount":42},"100623338","phase-2-elacestrant-and-exemestane-for-patients-with-pretreated-hrher2--metastatic-breast-cancer-and-18f-fes-avid-lesions-combine-100623338","NCT07395336","Elacestrant and Exemestane for Patients With Pretreated HR+\u002FHER2- Metastatic Breast Cancer and [18F] FES-avid Lesions (COMBINE)","Elacestrant and Exemestane for Patients With Pretreated HR+\u002FHER2- Metastatic Breast Cancer and [18F] FES-avid Lesions (COMBINE): a Proof-of-concept Phase 2 Clinical Trial","COMBINE-01","Inclusion Criteria:\n\n1. Must be at least 18 years old;\n2. Must have a histologically- or cytologically-proven diagnosis of carcinoma of the breast with evidence of either locally advanced disease not amenable to resection or radiation therapy with curative intent or metastatic disease not amenable to curative therapy\n3. Must be appropriate candidates for endocrine therapy (no visceral crisis, highly symptomatic disease or rapidly progressing disease)\n4. Must have 1 of the following as defined by RECIST v1.1:\n\n   1. Measurable disease\n   2. Bone only disease with evaluable lesions. Subjects must have at least 1 lytic or mixed lytic\u002Fblastic bone lesion; blastic lesions only are not evaluable and allowed. Subjects who have had prior radiation to bone must have at least 1 evaluable lesion in a nonirradiated area.\n5. ≥50% of measurable lesions defined as avid (SUVmax≥1.5) at 18F-FES-PET\u002FCT;\n6. Must have HR+ and HER2- disease at the last previous biopsy. ER and HER2 testing must be performed in the following manner:\n\n   1. Documentation of ER+ tumor with ≥ 10% staining by immunohistochemistry (IHC), with or without PgR positivity AND\n   2. Documentation of HER2- tumor with an IHC result of 0 or 1+ for cellular membrane protein expression or an in situ hybridization negative result as defined in the 2023 ASCO recommendations for HER2 testing (Wolff, 2013; Wolff, 2018; Wolff 2023)\n\n8\\. Must have progressed during or within 28 days of completion of prior treatment with a CDK4\u002F6 inhibitor in combination with anastrozole or letrozole (+ LHRH agonist for male or premenopausal female patients).\n\n1. This treatment has to be received in first line setting for metastatic disease (with abemaciclib, ribociclib or palbociclib)\n2. Discontinuation of prior CDK4\u002F6 inhibitor due to toxicity, in the absence of progression, will not fulfill this criterion\n3. Patients must have received the combination treatment for at least 12 months and there must have been evidence of disease control (stable disease \\[SD\\], partial response \\[PR\\] or complete response \\[CR\\] as best response) 9. Must have received no other treatment after the CDK4\u002F6 inhibitor combined with endocrine therapy 10. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1\n\nExclusion Criteria:\n\n1. Prior treatment with fulvestrant, elacestrant or investigational SERD or ER antagonist in metastatic or early disease (e.g., D-0502, GDC-0810, GDC-0927, GDC-9545, G1T-48, LSZ102, AZD9496, SAR439859, ZN-c5, H3B-6545, bazedoxifene, lasofoxifene)\n2. Prior treatment with tamoxifen or SERD alone or combined with CDK4\u002F6i in metastatic setting\n3. Any other endocrine therapy \\\u003C 14 days before first dose of study drug\n4. Any prior treatment after first line with CDK4\u002F6i in metastatic setting\n5. Bisphosphonates or RANKL inhibitors initiated or dose changed \\\u003C 3 months prior to first dose of study drug\n6. Radiation therapy within 14 days (28 days for brain lesions) before the first dose of study drug",{"count":178,"type":22},26,[180],"PHASE2","Single agent endocrine therapy (ET), with selective estrogen receptor degraders (SERDs; i.e. fulvestrant or elacestrant), is an option for patients with pre-treated hormone receptor-positive (HR+) breast cancer (BC) with indolent behaviour beyond the first line therapy with CDK4\u002F6 inhibitors (CDK4\u002F6i) + ET, in order to spare the adverse events related to chemotherapy.\n\nAnyway, the efficacy of endocrine monotherapy in patients progressing on first line therapy is low, because of the occurrence of endocrine resistance mechanisms, like the HR loss and the switch to HR-negative subtype, caused by the selective pressure of first line therapy; furthermore, biomarkers for patient selection are missing.\n\nRecently, the 16a-\\[18F\\]fluoro-17b-estradiol positron emission tomography (\\[18F\\]FES-PET) demonstrated a sensitivity and specificity of 86% in estrogen receptor expression prediction; therefore it is a promising tool to select patients progressing on CDK4\u002F6i + ET without HR loss.\n\nSingle agent endocrine therapy (ET), with selective estrogen receptor degraders (SERDs; i.e. fulvestrant or elacestrant), is an option for patients with pre-treated hormone receptor-positive (HR+) breast cancer (BC) with indolent behaviour beyond the first line therapy with target cyclin-dependent kinases 4 and 6 inhibitors (CDK4\u002F6i) + ET, in order to spare the adverse events related to chemotherapy.\n\nAnyway, the efficacy of endocrine monotherapy in patients progressing on first line therapy is low, because of the occurrence of endocrine resistance mechanisms, like the Hormon Receptor (HR) loss and the switch to HR-negative subtype, caused by the selective pressure of first line therapy; furthermore, biomarkers for patient selection are missing.\n\nRecently, the 16a-\\[18F\\] fluoro-17b-estradiol positron emission tomography (\\[18F\\] FES-PET) demonstrated a sensitivity and specificity of 86% in estrogen receptor expression prediction; therefore it is a promising tool to select patients progressing on CDK4\u002F6i + ET without HR loss.\n\nThe combination of endocrine agent, namely fulvestrant 250 mg plus anastrozole 1 mg (an aromatase inhibitor), demonstrated to provide an overall survival benefit in patients with Hormon Receptor positive Breast Cancer only in first line setting but not in patients progressing to ET. However, meanwhile, fulvestrant 500 mg was demonstrated to be superior to fulvestrant 250 mg in 2nd line setting, and oral SERDs (e.g. Elacestrant, Camizestrant) were demonstrated to be superior in terms of Progression Free Survival to fulvestrant 500 mg in patients progressing on ET, in the subgroup of patients with estrogen receptor 1 gene (ESR1) mutations.\n\nHypothesis: there is a strong rationale to assess the safety and the activity of Elacestrant plus exemestane in patients with pre-treated HR+ and Human Epidermal Growth Factor Receptor 2 negative (HER2-) metastatic breast cancer and at least 50% of \\[18F\\]FES-avid measurable lesions, using \\[18F\\]FES PET\u002FCT to evaluate the early response to treatment.",[138],[184,185,186,187],"elacestrant","exemestane","HR+","HER2-","2026-05-13",{"date":190,"type":34},"2026-05-14",{"date":192,"type":34},"2026-05-11",{"date":194,"type":22},"2028-12",{"name":40,"class":41},{"id":197,"slug":198,"hasResults":12,"nctId":199,"briefTitle":200,"officialTitle":201,"acronym":4,"eligibilityCriteria":202,"healthyVolunteers":100,"sex":101,"minAge":19,"maxAge":203,"enrollmentInfo":204,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":206,"conditions":207,"keywords":4,"overallStatus":210,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":211,"startDateStruct":212,"completionDateStruct":214,"leadSponsor":216,"locationsCount":42},"100640750","cognitive-impairment-assessment-in-breast-cancer-survivors-100640750","NCT07582770","Cognitive Impairment Assessment in Breast Cancer Survivors","Validation of Neuropsychological Tests for the Assessment of Cognitive Impairment in Breast Cancer Survivors","Inclusion Criteria:\n\n* Age between 18 and 65 years old\n* Patient with a previous documented diagnosis of non-metastatic breast cancer (only for breast cancer survivor gruop)\n* Patient has completed chemotherapy for at least 6 months and for a maximum of 36 months if planned (only for breast cancer survivor gruop)\n* Understanding of the Italian language and ability to give informed consent\n\nExclusion Criteria:\n\n* Presence of brain metastases or history of brain radiation therapy (only for breast cancer survivor gruop)\n* Patient with previous diagnosis of other malignant tumors in addition to breast cancer (only for breast cancer survivor gruop)\n* Patient with a previous diagnosis of malignant carcinomas (only for control gruop)\n* Patient with a history of brain damage with unresolved neurological consequences\n* Patient with previous or current serious neurological pathologies\n* Patient with severe psychiatric conditions\n* Patient with systemic pathologies that could interfere with cognitive abilities\n* Patient taking medications that have a strong cognitive impact and that have not been stabilized for at least 4 weeks prior to enrollment\n* Patient with visual or hearing impairments that are not properly corrected\n* Patient with any disability that might compromise the validity of cognitive tests","65 Years",{"count":205,"type":22},200,"This study is a monocentric, observational, cross-sectional study with a case-control design, aimed at evaluating the construct validity, discriminative ability, and diagnostic accuracy of a second-level neuropsychological test battery for the detection of cancer-related cognitive impairment in breast cancer survivors.",[208,209],"Cancer Related Cognitive Impairment","Breast Cancer Survivors","NOT_YET_RECRUITING",{"date":188,"type":34},{"date":213,"type":22},"2026-05",{"date":215,"type":22},"2030-04",{"name":40,"class":41},{"id":218,"slug":219,"hasResults":12,"nctId":220,"briefTitle":221,"officialTitle":222,"acronym":4,"eligibilityCriteria":223,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":224,"enrollmentInfo":225,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":227,"conditions":228,"keywords":230,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":232,"lastUpdatePostDateStruct":233,"startDateStruct":235,"completionDateStruct":237,"leadSponsor":239,"locationsCount":42},"100632025","role-of-the-immune-system-in-preventing-laryngeal-cancer-100632025","NCT07508319","Role of the Immune System in Preventing Laryngeal Cancer","Laryngeal Dysplasia and Progression to Carcinoma: Investigating Genetic and Immune Alterations Predictive of Malignant Transformation","Inclusion Criteria:\n\n* Histopathological diagnosis of laryngeal dysplasia.\n* Age \\>18 years and informed consent.\n\nExclusion Criteria:\n\n* Prior surgical, radiotherapeutic, or oncologic treatments for head and neck regions.\n* Congenital or acquired immunodeficiency disorders.\n* Synchronous malignancies.\n* Immunosuppressive therapy.\n* Age \\\u003C18 years or absence of research consent.","99 Years",{"count":226,"type":22},3,"Laryngeal dysplasia and progression to carcinoma: investigating genetic and immune alterations predictive of malignant transformation",[229],"Head & Neck Cancer",[231],"Laryngeal dysplasia","2026-03-31",{"date":234,"type":34},"2026-04-02",{"date":236,"type":34},"2025-11-19",{"date":238,"type":22},"2026-12-31",{"name":40,"class":41},{"id":241,"slug":242,"hasResults":12,"nctId":243,"briefTitle":244,"officialTitle":245,"acronym":246,"eligibilityCriteria":247,"healthyVolunteers":12,"sex":101,"minAge":19,"maxAge":4,"enrollmentInfo":248,"targetDuration":250,"studyType":23,"phases":4,"briefSummary":251,"conditions":252,"keywords":254,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":256,"lastUpdatePostDateStruct":257,"startDateStruct":259,"completionDateStruct":261,"leadSponsor":263,"locationsCount":42},"100574684","integrated-testing-strategy-for-simultaneous-detection-of-esr-1-and-gbrca-mutations-via-liquid-biopsy-in-hrher2--metastatic-breast-cancer-mbc-patients-100574684","NCT06762483","Integrated Testing Strategy for Simultaneous Detection of ESR-1 and gBRCA Mutations Via Liquid Biopsy in HR+\u002FHER2- Metastatic Breast Cancer (mBC) Patients,","Development and Validation of an Integrated Testing Strategy for Simultaneous Detection of ESR-1 and gBRCA Mutations Via Liquid Biopsy in HR+\u002FHER2- Metastatic Breast Cancer (mBC) Patients, and the Creation of a Digital Gene Library to Support an Evidence-based Diagnostic Algorithm","L2-268","Inclusion Criteria:\n\n* Participants must have a confirmed diagnosis of estrogen receptor-positive (ER+) and\u002For progesterone receptor-positive (PgR+) breast cancer through histological and\u002For cytological examination by the local laboratory Participants must exhibit HER2-negative breast cancer\n\n  1. or 2+). If IHC is 2+, a negative in situ hybridization (Fluorescent in situ hybridization (FISH), Chromogenic in situ hybridization (CISH), or Silver-enhanced in situ hybridization (SISH)) test is required by local laboratory testing.\n\n     * Participants should be in an advanced or metastatic setting including both those prior to the initiation of treatment for metastatic disease and those who experienced progression following treatment with cyclin-dependent kinases (CDK)4\u002F6 inhibitors. However, the primary tumor should be treated according to the standard of care.\n     * Written informed consent must be signed and dated by the patient and the investigator prior to inclusion.\n\nExclusion Criteria:\n\n* Unable to provide written informed consent",{"count":249,"type":22},80,"24 Months","Development and validation of an integrated testing strategy for simultaneous detection of ESR-1 and gBRCA mutations via liquid biopsy in HR+\u002FHER2- metastatic breast cancer (mBC) patients, and the creation of a digital gene library to support an evidence-based diagnostic algorithm",[253],"Breast Cancer, Metastatic",[255],"HR+\u002FHER2- BRCA","2026-03-23",{"date":258,"type":34},"2026-03-24",{"date":260,"type":34},"2024-12-20",{"date":262,"type":22},"2030-12-31",{"name":40,"class":41},{"id":265,"slug":266,"hasResults":12,"nctId":267,"briefTitle":268,"officialTitle":269,"acronym":270,"eligibilityCriteria":271,"healthyVolunteers":12,"sex":272,"minAge":19,"maxAge":4,"enrollmentInfo":273,"targetDuration":275,"studyType":23,"phases":4,"briefSummary":276,"conditions":277,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":256,"lastUpdatePostDateStruct":279,"startDateStruct":280,"completionDateStruct":281,"leadSponsor":282,"locationsCount":42},"100574676","implementation-of-a-new-algorithm-for-hrr-gene-mutation-testing-in-patients-with-mpc-through-liquid-biopsy-integration-100574676","NCT06762379","Implementation of a New Algorithm for HRR Gene Mutation Testing in Patients With mPC Through Liquid Biopsy Integration","Implementation of a New Algorithm for HRR Gene Mutation Testing in Patients With mPC","L2-267","Inclusion Criteria:\n\n* Patients with metastatic prostate cancer whose tumor tissue is unavailable or inadequate for molecular testing. • Written informed consent must be signed and dated by the patient and the investigator prior to inclusion.\n\nExclusion Criteria:\n\n* Unable to provide written informed consent","MALE",{"count":274,"type":22},125,"36 Months","Implementation of a new algorithm for HRR gene mutation testing in patients with mPC through liquid biopsy integration",[278],"Metastatic Prostate Cancer (mPC)",{"date":258,"type":34},{"date":260,"type":34},{"date":262,"type":22},{"name":40,"class":41},{"id":284,"slug":285,"hasResults":12,"nctId":286,"briefTitle":287,"officialTitle":288,"acronym":4,"eligibilityCriteria":289,"healthyVolunteers":12,"sex":101,"minAge":19,"maxAge":4,"enrollmentInfo":290,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":292,"conditions":293,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":256,"lastUpdatePostDateStruct":295,"startDateStruct":296,"completionDateStruct":298,"leadSponsor":299,"locationsCount":42},"100570386","pik3ca-mutational-status-assessment-100570386","NCT06706570","PIK3CA Mutational Status Assessment","PIK3CA Mutational Status Assessment: Towards a \"Tailored\" Diagnostic Approach","Inclusion Criteria:\n\n* Participant has a histologically and\u002For cytologically confirmed diagnosis of ER+ and\u002For PgR+ breast cancer by local laboratory.\n* Participant has HER2-negative breast cancer defined as a negative in situ hybridization test or an IHC status of 0, 1+ or 2+. If IHC is 2+, a negative in situ hybridization (Fluorescent in situ hybridization (FISH), Chromogenic in situ hybridization (CISH), or Silver-enhanced in situ hybridization (SISH)) test is required by local laboratory testing.\n* Participants should be at advanced or metastatic setting prior to treatment.\n* Written informed consent must be signed and dated by the patient and the investigator prior to inclusion.\n* Patients must be accessible for follow-up.\n\nExclusion Criteria:\n\n• patients already treated with different treatments like chemotherapy, hormone therapy etc",{"count":291,"type":22},100,"Evaluation of PIK3CA mutational status: a route towards a tailored diagnostic approach.",[294],"Breast Cancer Metastatic",{"date":258,"type":34},{"date":297,"type":34},"2024-11-06",{"date":262,"type":22},{"name":40,"class":41},{"id":301,"slug":302,"hasResults":12,"nctId":303,"briefTitle":304,"officialTitle":305,"acronym":306,"eligibilityCriteria":307,"healthyVolunteers":12,"sex":101,"minAge":19,"maxAge":4,"enrollmentInfo":308,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":310,"conditions":311,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":256,"lastUpdatePostDateStruct":313,"startDateStruct":314,"completionDateStruct":316,"leadSponsor":317,"locationsCount":42},"100570385","analysis-of-circulating-tumor-dna-ctdna-in-her2-low-advancedmetastatic-breast-cancer-100570385","NCT06706557","Analysis of Circulating Tumor DNA (ctDNA) in HER2-low Advanced\u002FMetastatic Breast Cancer","A Pilot Study on the Analysis of Circulating Tumor DNA (ctDNA) in HER2-low Advanced\u002FMetastatic Breast Cancer","LEGO","Inclusion Criteria\n\n* Participants diagnosed with HER2-low breast cancer, defined as IHC score 1+ or 2+ and not amplified at in situ hybridization (ISH) test as confirmed by local laboratory testing.\n* Participants should be at advanced or metastatic setting prior to treatment.\n* Written informed consent (Accordo di Partecipazione alla Ricerca Scientifica) and specific informed consent to the study must be signed and dated by the patient and the doctor prior to inclusion.\n* Patients must be accessible for follow-up.",{"count":309,"type":22},30,"A Pilot study on circulating tumor DNA (ctDNA) in advanced\u002Fmetastatic breast cancer with low levels of HER2 expression (HER2 low)",[312],"Advanced Metastatic Breast Cancer",{"date":258,"type":34},{"date":315,"type":34},"2024-01-11",{"date":262,"type":22},{"name":40,"class":41},{"id":319,"slug":320,"hasResults":12,"nctId":321,"briefTitle":322,"officialTitle":323,"acronym":324,"eligibilityCriteria":325,"healthyVolunteers":12,"sex":18,"minAge":326,"maxAge":224,"enrollmentInfo":327,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":328,"conditions":329,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":256,"lastUpdatePostDateStruct":331,"startDateStruct":332,"completionDateStruct":334,"leadSponsor":335,"locationsCount":42},"100542541","predicting-toxicity-in-elderly-patients-with-head-and-neck-cancer-100542541","NCT06344208","Predicting Toxicity in Elderly Patients With Head and Neck Cancer","Predicting Toxicity in Elderly Patients With Head and Neck Cancer: Validating a Disease-oriented Toxicity Predictive Tool and Integrating it With Available Screening Tools for Better Outcomes","PREtoxEL","Inclusion Criteria:\n\n* Patients aged ≥ 70 years\n* Histological diagnosis of squamous cell or undifferentiated HNC in stage III-IV AJCC ed VIII (si-nonasal, nasopharynx, oral cavity, oropharynx, unknown primary with HPV pos, larynx and hy-popharynx) and candidated to curative non surgical treatment (radiotherapy alone, Chemora-diation with platinum salts; radiation+cetuximab)\n* Evaluable disease accordingly to RECIST criteria 1.1\n* Willing of sign a written informed consent\n* Adequate organ function\n\nExclusion Criteria:\n\nPatient with cancer in other sites than HN \\\u003C than 2 years except for prostate cancer cT1-2, Gleason 3+3, NIMBC, initial Non Melanoma Skin Cancer, in situ cervical cancer)\n\n* PS ECOG 3-4\n* Patients who received systemic treatments in the past for other primary tumors","70 Years",{"count":226,"type":22},"Predicting toxicity in elderly patients with head and neck cancer:\n\nvalidating a disease-oriented toxicity predictive tool and integrating it with avail-able screening tools for better outcomes.",[330],"Head and Neck Cancer",{"date":258,"type":34},{"date":333,"type":34},"2022-03-15",{"date":238,"type":22},{"name":40,"class":41},{"id":337,"slug":338,"hasResults":12,"nctId":339,"briefTitle":340,"officialTitle":341,"acronym":342,"eligibilityCriteria":343,"healthyVolunteers":12,"sex":18,"minAge":4,"maxAge":4,"enrollmentInfo":344,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":346,"conditions":347,"keywords":350,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":357,"lastUpdatePostDateStruct":358,"startDateStruct":360,"completionDateStruct":362,"leadSponsor":363,"locationsCount":42},"100625993","comparative-analysis-between-thymic-pulmonary-and-pancreatic-well-differentiated-high-grade-neuroendocrine-tumors-100625993","NCT07429851","CompArative Analysis Between, Thymic, pulmonaRy and Pancreatic Well Differentiated High Grade Neuroendocrine Tumors","CLINical, Pathological and outcomE compArative Analysis Between, Thymic, pulmonaRy and Pancreatic Well Differentiated High Grade Neuroendocrine Tumors: a Retrospective Observational Study","LINEAR","Inclusion Criteria:\n\n* Histologically confirmed diagnosis of well-differentiated high grade neuroendocrine tumor (Ki-67 \\> 20% according to WHO 2022) performed or reviewed by a NEN-dedicated pathologist.\n* Primary tumor site:thyme, lung and duodenum-pancreas NETs.\n* Advanced stage of tumor disease and Any number of lines of therapy\n* Sufficient available clinical data on diagnosis, treatments, outcomes.\n\nExclusion Criteria:\n\n* Poorly differentiated neuroendocrine carcinomas (NECs), GEP NET G1\u002FG2, pulmonary carcinoid with Ki-67 \\\u003C 20%.\n* Diagnosis of mixed neuroendocrine non-neuroendocrine neoplasms (MiNENs)\n* Inadequate or unavailable tumor tissue for molecular analysis.\n* Incomplete clinical records or follow-up.\n* Other primary sites, except lung or pancreas.",{"count":345,"type":22},34,"The study involves the enrollment of 34 patients diagnosed with advanced thymic, pulmonary and duodeno-pancreatic well-differentiated high grade neuroendocrine tumors (Ki-67 \\> 20%). The objective of this retrospective single-centre translational study will be to explore whether patients differ clinically in terms of diagnosis and treatment management. Currently, well differentiated high grade pulmonary NETs are managed using extrapolated algorithms from duodeno-pancreatic NETs, underlining a significant unmet clinical need. This is likely due to the rarity, uncertain pathological and molecular classification, and heterogeneous clinical course of well differentiated high grade pulmonary NETs.\n\nIn this study a retrospective data-base of pulmonary, thymic and duodeno-pancreatic NETs with Ki-67 \\> 20% will be created in order to analyze diagnostic and therapeutic pathways, clinical outcomes, imaging, disease evolution and molecular profiling. This study will adopt a hypothesis-generating approach to explore whether patients in these distinct groups differ clinically in terms of diagnosis and treatment management.",[348,349],"Neuroendocrine Carcinoma of Lung","Neuroendocrine Carcinoma of Thymus",[351,352,353,354,355,356],"therapeutic algorithm","overall survival","first line progression-free survival","time to progression","genetic alterations","clinical outcomes","2026-02-17",{"date":359,"type":34},"2026-02-24",{"date":361,"type":34},"2026-01-01",{"date":232,"type":22},{"name":40,"class":41},{"id":365,"slug":366,"hasResults":12,"nctId":367,"briefTitle":368,"officialTitle":369,"acronym":370,"eligibilityCriteria":371,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":372,"enrollmentInfo":373,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":375,"conditions":376,"keywords":379,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":357,"lastUpdatePostDateStruct":384,"startDateStruct":386,"completionDateStruct":388,"leadSponsor":390,"locationsCount":42},"100625850","real-world-zolbetuximab-in-patients-with-her-2-negative-and-claudin-182-positive-metastatic-adenocarcinoma-100625850","NCT07427992","Real-WorlD ZolbetUximab in Patients With HER-2 Negative and CLaudin 18.2 PosItive MetastatiC AdEnocarcinoma","Real-WorlD ZolbetUximab Combined With chemotheraPy in Patients With HER-2 Negative and CLaudin 18.2 PosItive MetastatiC GAsTric or Gastroesophageal Junction AdEnocarcinoma","DUPLICATE","Inclusion Criteria:\n\n* Patient with histologically confirmed diagnosis of gastric or gastroesophageal junction adenocarcinoma.\n* Patient with locally advanced, unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma.\n* Patient whose tumor expresses claudin18.2 in ≥ 75% of tumor cells demonstrating moderate to strong membranous CLDN18 staining as determined by local or central immunohistochemistry testing.\n* Patient with a Human epidermal growth factor receptor 2 negative tumor by local testing on a gastric or gastroesophageal junction tumor specimen.\n* Patient with Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.\n* Patient who can have access to the Zolbetuximab EAP program or locally authorized and reimbursed (AIFA) procedure.\n* Patient who has about to start first-line Zolbetuximab + FOLFOX\u002FXELOX or who has an ongoing Zolbetuximab FOLFOX\u002FXELOX with available clinical data.\n\nExclusion Criteria:\n\n* Patient has previously received treatment in a clinical trial of zolbetuximab, or a clinical trial that included zolbetuximab as 1 of the treatment options, even if the patient was not given zolbetuximab.\n* Patient has known dihydropyrimidine dehydrogenase deficiency.\n* Patient has received prior systemic chemotherapy for locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma. However, patient may have received either neoadjuvant or adjuvant chemotherapy, immunotherapy or other systemic anticancer therapies as long as it was completed at least 6 months prior to participation.","100 Years",{"count":374,"type":22},70,"The primary objective is to validate, throughout a national real-world study, the efficacy and safety of Zolbetuximab combined with FOLFOX or XELOX regimens. Specific clinical issues will be studied by pre-planned subgroup analyses, addressing practical clinical needs which have not been specifically investigated in randomized clinical trials.",[377,378],"Gastric Adenocarcinoma","Gastroesophageal Junction Adenocarcinoma",[380,381,377,382,383],"claudin","real world study","zolbetuximab","gastroesophageal junction adenocarcinoma",{"date":385,"type":34},"2026-02-23",{"date":387,"type":34},"2025-06-20",{"date":389,"type":22},"2027-06-30",{"name":40,"class":41},{"id":392,"slug":393,"hasResults":12,"nctId":394,"briefTitle":395,"officialTitle":396,"acronym":397,"eligibilityCriteria":398,"healthyVolunteers":100,"sex":18,"minAge":399,"maxAge":4,"enrollmentInfo":400,"targetDuration":4,"studyType":104,"phases":401,"briefSummary":402,"conditions":403,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":405,"lastUpdatePostDateStruct":406,"startDateStruct":408,"completionDateStruct":410,"leadSponsor":411,"locationsCount":412},"100624967","digital-solutions-for-better-care-100624967","NCT07416513","Digital Solutions for bEtter cAre","ALTHEA: tAckLing menTal Health Cancer Patients and Their Families: Digital Solutions for bEtter cAre","ALTHEA","Inclusion Criteria:\n\nHEALTHCARE PROFESSIONALS:\n\n* Healthcare professionals actually working in oncology and\u002For psychooncology;\n* Teachers of paediatric cancer patients.\n\nADULT POPULATION:\n\n* Patients with a current or previous cancer diagnosis\n* Adequate language proficiency,\n* Able to provide informed consent;\n\nPAEDIATRIC POPULATION:\n\n* Older than 12 years of age;\n* Patients with a current or previous cancer diagnosis;\n* Adequate language proficiency;\n* Legal guardians of paediatric cancer patients able to provide informed consent.\n\nCAREGIVERS:\n\n* Caregivers and\u002For family members of cancer patients who lived or assist the loved ones with a current or previous cancer diagnosis in the cancer journey;\n* Adequate language proficiency;\n* Able to provide informed consent;\n* Caregivers and\u002For family members of paediatric cancer patients under 12 years of age.\n\nExclusion Criteria:\n\n* Healthcare professionals with limited oncology patient contact;\n* Insufficient knowledge of the local language;\n* Severe cognitive impairment, and\u002For mental disorders that prohibited their participation in the study or inadequate verbal skills that may render them incapable of informed consent (as evaluated by the clinician);\n* Inability to understand the study materials (as evaluated by the clinician);\n* Physical or psychological impairment that prohibits their participation in focus groups (as evaluated by the clinician).","12 Years",{"count":205,"type":22},[106],"The target population includes cancer patients, caregivers, family members, healthcare providers and mental health specialists, who will be the primary end-users of the Althea platform. For patients, survivors, caregivers, and family members, the sample variables include age, gender, type and stage of disease, and time since the first diagnosis. The healthcare professionals that will be involved in this study are those who attend to oncological patients, with sample variables such as age, gender, professional role, and prior experience and training in oncology or psycho-oncology.",[404],"Cancer Diagnosis","2026-02-16",{"date":407,"type":34},"2026-02-18",{"date":409,"type":34},"2025-05-14",{"date":238,"type":22},{"name":40,"class":41},5,{"id":414,"slug":415,"hasResults":12,"nctId":416,"briefTitle":417,"officialTitle":418,"acronym":4,"eligibilityCriteria":419,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":51,"enrollmentInfo":420,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":422,"conditions":423,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":427,"lastUpdatePostDateStruct":428,"startDateStruct":430,"completionDateStruct":432,"leadSponsor":434,"locationsCount":42},"100625227","germline-genetic-testing-of-the-tp53-gene-100625227","NCT07419893","Germline Genetic Testing of the TP53 Gene","Germline Genetic Testing of the TP53 Gene: Identification, Characterization, and Management of Patients and Families at High Risk of Cancer","Inclusion Criteria:\n\n* Have undergone at least one genetic counseling session at the Division of Cancer Prevention and Genetics of the IEO;\n* Have undergone germline TP53 genetic testing, regardless of the referral criteria for counseling and\u002For testing or the approach used;\n* Have provided written informed consent for participation in scientific research.\n\nExclusion Criteria:\n\n* Absence of signed informed consent for participation in scientific research.",{"count":421,"type":22},1940,"This is a retrospective, observational, single-center study designed as a cohort analysis. The study population will include consecutive patients referred for genetic counseling and TP53 germline genetic testing between 2004 and 2025 at the Division of Cancer Prevention and Genetics of the IEO. The primary endpoint is to determine the overall detection rate of Pathological Variants (PVs) in the TP53 gene among individuals referred to the institute and the differences between the groups.",[424,425,426],"TP53 Gene Mutation","Multi-Gene Transcriptional Profiling","TP53 Gene Germline Mutation Carrier","2026-02-12",{"date":429,"type":34},"2026-02-19",{"date":431,"type":34},"2026-01-29",{"date":433,"type":22},"2031-01",{"name":40,"class":41},{"id":436,"slug":437,"hasResults":12,"nctId":438,"briefTitle":439,"officialTitle":440,"acronym":441,"eligibilityCriteria":442,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":443,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":445,"conditions":446,"keywords":448,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":450,"lastUpdatePostDateStruct":451,"startDateStruct":453,"completionDateStruct":455,"leadSponsor":457,"locationsCount":42},"100571725","evaluation-of-her2dx-assay-on-treatment-decisions-in-patients-with-early-stage-her2-breast-cancer-the-her2breastdx-100571725","NCT06723990","Evaluation of HER2DX Assay on Treatment Decisions in Patients With Early Stage HER2+ Breast Cancer: the HER2BREASTDX","Prospective Observational Monocentric Study to Evaluate the Impact of the HER2DX Assay on Treatment Decisions in Patients With Early Stage HER2+ Breast Cancer: the HER2-BREAST-DX","HER2BREASTDX","Inclusion Criteria:\n\n* Patients ≥ 18 years of age;\n* Histologically confirmed HER2+ breast cancer;\n* Stage I-III breast cancer without evidence of distant metastases;\n* Being candidate to neoadjuvant\u002Fadjuvant therapy and locoregional treatment (surgery +\u002F- radiotherapy);\n* Written informed consent, signed by the patient, to study-specific procedures (the consent will consist of 2 levels: level 1 specifically for patients enrolled in the primary endpoint cohort and level 2 for all patients);\n\nExclusion Criteria:\n\n* HER2- BC;\n* Stage IV breast cancer;\n* Lack of informed consent because of patient's incapable of discernment or unwilling to participate;",{"count":444,"type":22},60,"To prospectively evaluate the impact of HER2DX on the decision-making processes of the treating physicians and especially among the routine multidisciplinary tumour board, in defining type and setting of systemic therapy administration in patients with stage I-III HER2+ BC, and the degree of clinician's confidence in the treatment recommendation.",[447],"Breast Cancer Early Stage Breast Cancer (Stage 1-3)",[449],"HER2 positive breast cancer patients with stage I-III","2026-02-09",{"date":452,"type":34},"2026-02-11",{"date":454,"type":34},"2024-10-24",{"date":456,"type":22},"2027-11",{"name":40,"class":41},{"id":459,"slug":460,"hasResults":12,"nctId":461,"briefTitle":462,"officialTitle":463,"acronym":4,"eligibilityCriteria":464,"healthyVolunteers":12,"sex":101,"minAge":19,"maxAge":4,"enrollmentInfo":465,"targetDuration":4,"studyType":104,"phases":466,"briefSummary":467,"conditions":468,"keywords":469,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":450,"lastUpdatePostDateStruct":471,"startDateStruct":472,"completionDateStruct":474,"leadSponsor":476,"locationsCount":42},"100563007","fasting-mimicking-diet-intervention-on-side-effects-of-aromatase-inhibitors-treatment-in-patients-with-breast-cancer-100563007","NCT06610565","Fasting-mimicking Diet Intervention on Side Effects of Aromatase Inhibitors Treatment in Patients With Breast Cancer","Fasting-mimicking Diet: A Randomized Trial on Feasibility, Safety and Effects of Multicycle Dietary Intervention on Side Effects of Aromatase Inhibitors Treatment in Post-menopausal Patients With Breast Cancer","Inclusion Criteria:\n\n* Age ≥ 18 years\n* WHO performance status score 0-2\n* Early stage breast cancer, ER positive, receiving an adjuvant endocrine treatment with aromatase inhibitor\n* Hypercholesterolemic (total cholesterol \\>200mg\u002FdL)\n* Ongoing treatment with aromatase inhibitors (at least six months of drug exposure)\n* Adequate renal, hepatic, and hematopoietic function\n* Written and informed consent for biomaterial submission and participation in the clinical trial\n* Compliance with treatment and follow up protocol\n* No other investigational agent may be administered concurrently to patients enrolled in this trial\n* Patients with skeletal pain are eligible if bone scan and\u002For RX examination fails to disclose metastatic disease\n* The interval between the onset of systemic adjuvant therapy with AIs and the randomization should be at least 6 months\n* Patient is accessible geographically for follow-up and must be able to provide dietary data via telephone recalls\n* Must be medically able to accept either dietary supplementation group prior to randomization.\n\nExclusion Criteria:\n\n* Underweight (BMI \\< 18.5 kg\u002Fm2)\n* Current or past eating disorders identified with the SCOFF Questionnaire (Useful Eating Disorder screening questions) \\[19\\]\n* Malnutrition Universal Screening Tool (MUST). It considers body mass index, weight change and acute disease effect equally and determines a malnutrition risk score. A score ≥1 identify a patient at moderate risk of malnutrition;\n* Treatment with any investigational or non-registered drug other than the study product(s) within 30 days preceding the first dose of study product, or planned use during the study period\n* Use of statins or supplements similar to statins (e.g red rice) or other drugs that interfere with lipid absorption (e.g ezetimibe)\n* Known to have difficult-to-control hypertension, coronary artery disease, arrhythmia requiring treatment, clinically significant valvular disease, cardiomegaly on chest X-ray, ventricular hypertrophy on ECG, previous myocardial infarction, or congestive heart failure Patients with diabetes are not eligible for the study\n* History of allergic reactions likely to be exacerbated by any component of the investigational product used in the study\n* Other concurrent, severe medical problems, unrelated to the malignancy, that would significantly limit full compliance with the study or expose the patient to unacceptable risk\n* Previous or concomitant malignancies at other sites, except effectively treated malignancy that is considered by the Investigator to have been cured\n* Psychiatric or addictive disorders that may compromise the ability to give informed consent or to comply with study procedures.",{"count":444,"type":22},[106],"The primary endpoint of this study is to determine whether cycles of short term FMD exposure to a fasting-mimicking diet is effective in reducing total cholesterol levels.",[138],[470],"fasting-mimicking diet",{"date":452,"type":34},{"date":473,"type":34},"2024-09-01",{"date":475,"type":22},"2027-04-01",{"name":40,"class":41},{"id":478,"slug":479,"hasResults":12,"nctId":480,"briefTitle":481,"officialTitle":482,"acronym":4,"eligibilityCriteria":483,"healthyVolunteers":100,"sex":101,"minAge":19,"maxAge":4,"enrollmentInfo":484,"targetDuration":4,"studyType":104,"phases":485,"briefSummary":486,"conditions":487,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":490,"lastUpdatePostDateStruct":491,"startDateStruct":493,"completionDateStruct":495,"leadSponsor":497,"locationsCount":498},"100610967","sexual-well-being-of-women-undergoing-mastectomy-and-reconstruction-100610967","NCT07234461","Sexual Well-being of Women Undergoing Mastectomy and Reconstruction","Sexual Well-being of Women Undergoing Mastectomy and Reconstruction: a National Survey.","Inclusion Criteria:\n\n* Patients undergoing mastectomy for primary breast cancer;\n* High-risk healthy patients undergoing risk reducing mastectomies;\n* Unilateral and\u002For bilateral mastectomies;\n* If unilateral mastectomy, both patients requiring or not contralateral mammaplasty of the healthy breast;\n* All reconstructive procedures included (autologous and heterologous reconstructions).\n\nExclusion Criteria:\n\n* Patients undergoing breast conservation;\n* Patients who previously underwent breast cancer treatment, requiring further surgery for local relapse or secondary breast cancers;\n* Delayed post-mastectomy reconstructions;\n* Patients not available for e-correspondence.",{"count":205,"type":22},[106],"The study plans to collect data from patients on sexual well-being after mastectomy and immediate reconstruction by surveys.\n\nThis data can support preoperative patient counselling and the prevention and care of adverse effects of cancer treatments.\n\nSpecific subpopulations of mastectomy women showing severe sexual impairment can be outlined; they may benefit from lifestyle changes and intervention strategies (intravaginal use of diazepam, local hyaluronic acid, intravaginal use of spermidine, pelvic floor gymnastic and physiotherapy).\n\nOur goal is to improve quality of life of breast cancer patients.",[488,489],"Mastectomy and Breast Reconstruction","Sexual Wellness","2026-02-02",{"date":492,"type":34},"2026-02-04",{"date":494,"type":34},"2026-01-21",{"date":496,"type":22},"2026-10",{"name":40,"class":41},19,{"id":500,"slug":501,"hasResults":12,"nctId":502,"briefTitle":503,"officialTitle":504,"acronym":505,"eligibilityCriteria":506,"healthyVolunteers":12,"sex":101,"minAge":19,"maxAge":507,"enrollmentInfo":508,"targetDuration":4,"studyType":104,"phases":510,"briefSummary":511,"conditions":512,"keywords":4,"overallStatus":210,"whyStopped":4,"lastUpdateSubmitDate":494,"lastUpdatePostDateStruct":516,"startDateStruct":517,"completionDateStruct":518,"leadSponsor":520,"locationsCount":42},"100621760","immunotherapy-efficacy-targeting-endometrial-cancer-100621760","NCT07374809","IMMUNOTHERAPY EFFICACY TARGETING ENDOMETRIAL CANCER","DISSECTING THE EPIGENOME AND MICROENVIRONMENT TO UNDERSTAND IMMUNOTHERAPY EFFICACY TARGETING ENDOMETRIAL CANCER (DEMETER PROJECT)","DEMETER","Inclusion Criteria:\n\n* Female patients ≥ 18 years old.\n* Histologically confirmed epithelial endometrial carcinoma (endometrioid, serous, clear cell, mixed, or carcinosarcoma).\n* Advanced (stage III-IV) or recurrent disease, eligible for surgery or biopsy as part of the therapeutic plan.\n* Availability of fresh-frozen or OCT-embedded tumor tissue obtained at surgery\u002Fbiopsy and stored in the IEO Biobank.\n* Mismatch-repair-deficient (dMMR) or -proficient (pMMR) molecular subtype (when available).\n* Written informed consent for participation and use of biological material for translational research purposes.\n\nExclusion Criteria:\n\n* Mesenchymal tumors or epithelial tumors of non-endometrial origin (e.g., ovarian, cervical).\n* Prior systemic treatment with immune checkpoint inhibitors for other malignancies.\n* Insufficient or poor-quality tumor tissue available for molecular analyses.\n* Active or uncontrolled infection with HIV, HBV, or HCV.\n* Any condition that, in the investigator's judgment, would compromise patient safety or study integrity.","120 Years",{"count":509,"type":22},50,[106],"Endometrial carcinoma (EC) represents the most common gynecological malignancy in developed countries. Despite therapeutic advances, patients with advanced or recurrent disease still have a poor prognosis, with high recurrence rates and a 5-year survival of less than 20%.\n\nRecently, four phase III studies (RUBY, NRG-GY018, AtTEnd, and DUO-E) have demonstrated that the addition of anti-PD-1\u002FPD-L1 immunotherapy to first-line chemotherapy significantly improves progression-free survival, particularly in tumors with altered DNA repair mechanisms known as mismatch repair (MMR) (so-called mismatch repair-deficient or dMMR tumors), but with benefits also observed in a subset of tumors with normal MMR function (so-called MMR-proficient or pMMR tumors). However, despite the clinical approval of these therapies, reliable biomarkers capable of predicting response to immunotherapy are still lacking.\n\nThis project aims to comprehensively characterize the genomic, epigenetic, and lipid properties of the tumor and the tumor microenvironment (TME) in order to identify predictive markers of response to immunotherapy, thereby laying the foundation for a personalized therapeutic approach in endometrial carcinoma.",[513,514,515],"Endometrial Carcinoma (EC)","pMMR","DMMR Cancer",{"date":431,"type":34},{"date":494,"type":22},{"date":519,"type":22},"2027-11-30",{"name":40,"class":41},{"id":522,"slug":523,"hasResults":12,"nctId":524,"briefTitle":525,"officialTitle":526,"acronym":527,"eligibilityCriteria":528,"healthyVolunteers":12,"sex":101,"minAge":19,"maxAge":4,"enrollmentInfo":529,"targetDuration":4,"studyType":104,"phases":531,"briefSummary":532,"conditions":533,"keywords":4,"overallStatus":210,"whyStopped":4,"lastUpdateSubmitDate":494,"lastUpdatePostDateStruct":535,"startDateStruct":537,"completionDateStruct":538,"leadSponsor":540,"locationsCount":42},"100598090","prevalence-of-germline-alterations-in-actionable-genes-in-endometrial-cancer-100598090","NCT07066969","Prevalence of Germline Alterations in Actionable Genes in Endometrial Cancer","Investigating the Prevalence of Germline Alterations in Actionable Genes in Endometrial Cancer","GerEC","Inclusion Criteria:\n\n* diagnosis of EC\n* tumoral BRCA mutation\n\nExclusion Criteria:\n\n* Age \\\u003C 18 years",{"count":530,"type":22},20,[106],"Endometrial cancer (EC) is the most common gynecological cancer in developed countries, with 10200 new cases of EC (5.5% of all cancers) estimated in 2023 and 2500 death for EC estimated in 2022 in Italy.\n\nRecently, the classical clinicopathological risk factors, such as age, FIGO stage, myometrial invasion, tumor grade, lymphovascular space invasion, and lymph node status, have been associated with molecular features for EC risk stratification. The recently introduced molecular classification, based on a very relevant publication of the \"Integrated genomic characterization of endometrial carcinoma\" by The Cancer Genome Atlas research network in 2013,2 requires the evaluation of three surrogate molecular markers, namely POLE sequencing, p53 immunohistochemical (IHC) evaluation, and mismatch repair (MMR) protein IHC evaluation, in order to reproduce the TCGA model and translate it into clinical practice.\n\nThis molecular-based risk stratification provides a more accurate prediction of recurrent or metastatic disease than traditional clinicopathological criteria; however, more molecular knowledge is needed to better understand EC. Recently, the European Institute of Oncology implemented a new molecular panel for somatic evaluation of EC (Sophia DDM). The panel includes 54 genes, including BRCA1 and BRCA2.",[534],"Endometrial Cancer",{"date":536,"type":34},"2026-01-22",{"date":536,"type":22},{"date":539,"type":22},"2027-04",{"name":40,"class":41},{"id":542,"slug":543,"hasResults":12,"nctId":544,"briefTitle":545,"officialTitle":546,"acronym":547,"eligibilityCriteria":548,"healthyVolunteers":12,"sex":101,"minAge":19,"maxAge":4,"enrollmentInfo":549,"targetDuration":4,"studyType":104,"phases":551,"briefSummary":552,"conditions":553,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":556,"lastUpdatePostDateStruct":557,"startDateStruct":559,"completionDateStruct":561,"leadSponsor":563,"locationsCount":42},"100599165","sentinel-lymph-node-biopsy-after-neoadjuvant-chemotherapy-in-ibc-100599165","NCT07080944","Sentinel Lymph Node Biopsy After Neoadjuvant Chemotherapy in IBC","Sentinel Lymph Node Biopsy After Neoadjuvant Chemotherapy in Inflammatory Breast Cancer: a Prospective Trial","SYMPHONY","Inclusion Criteria:\n\n* Female patients over 18 years of age with clinically and biopsy-proven stage IIIB cT4d cN0-2 M0 breast cancer as assessed by clinical exam and imaging\n* Patients receiving NACT and having a nodal complete clinical response (ycN0) as assessed by physical exam and imaging (ultrasound and PET)\n* Ability to understand and willingness to sign informed consent document and comply with study procedures\n\nExclusion Criteria:\n\n* Patients with cN3 stage at diagnosis\n* Participants with stage IV (metastatic) breast cancer\n* Participants with positive contralateral axillary nodes identified on standard imaging studies (mammograpy, MRI, ultrasound) and cito-histologically ascertained\n* Patients with a prior history of ipsilateral breast cancer\n* Pregnant patients\n* Patients after NACT with persistent palpable axillary nodes, as assessed by physical exam, or with persistent pathological axillary nodes, as assessed by imaging\n* Patients not consenting to ALND",{"count":550,"type":22},75,[106],"This study will prospectively determine the feasibility and oncological safety of sentinel lymph node biopsy (SLNB) after neoadjuvant chemotherapy (NACT) in inflammatory breast cancer patients traditionally considered ineligible for SLNB due to locally advanced cancer with skin\u002Fchest wall involvement (cT4d) and heavy nodal burden at presentation (cN1\u002FN2). This study will also assess the identification rate of sentinel lymph-node (SLN) (using single tracer mapping) after NACT in this patient population. Finally, the study will determine the long-term outcome of such cohort.",[554,57,555],"Invasive Breast Carcinoma","Neoadjuvant Chemotherapy","2026-01-02",{"date":558,"type":34},"2026-01-06",{"date":560,"type":34},"2025-12-12",{"date":562,"type":22},"2030-08",{"name":40,"class":41},{"id":565,"slug":566,"hasResults":12,"nctId":567,"briefTitle":568,"officialTitle":569,"acronym":570,"eligibilityCriteria":571,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":572,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":574,"conditions":575,"keywords":576,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":556,"lastUpdatePostDateStruct":579,"startDateStruct":580,"completionDateStruct":582,"leadSponsor":584,"locationsCount":42},"100596719","toxicity-markers-to-trastuzumab-deruxtecan-t-dxd-in-patients-with-advanced-breast-cancer-100596719","NCT07049133","Toxicity Markers to Trastuzumab-Deruxtecan (T-DXd) In Patients With Advanced Breast Cancer","Identification Of Toxicity Markers to Trastuzumab-Deruxtecan (T-DXd) In Patients With Advanced Breast Cancer. Tox-DXd: a Prospective, Observational Study","Tox-DXd","Inclusion Criteria:\n\n* Male or female, aged at least 18 years.\n* Histologically documented invasive breast cancer, either HER2-positive or HER2-low\u002Fultralow.\n* Candidate to receive T-DXd as per standard practice.\n* Consent for the provision of blood samples for exploratory analyses.\n\nExclusion Criteria:\n\n* Operable, non-metastatic breast cancer\n* Unwillingness to provide additional blood draws",{"count":573,"type":22},84,"the anti-Human Epidermal Growth Factor Receptor 2 (HER2) Trastuzumab-Deruxtecan (T-DXd) has shown impressive clinical activity in pretreated patients with metastatic breast cancer (MBC) but is also associated with a non-negligible rate of adverse events that may lead to treatment discontinuation and\u002For the onset of pneumonitis\u002Finterstitial lung disease (ILD)\n\nThe aim of the study is to identify and describe potentially predictive markers related to the onset of relevant T-DXd-related toxicities",[80],[80,577,578],"Trastuzumab-Deruxtecan","ILD\u002Fpulmonitis",{"date":558,"type":34},{"date":581,"type":34},"2025-07-31",{"date":583,"type":22},"2027-12-31",{"name":40,"class":41},""]