[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"vulva-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:vulva-cancer":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,10,0,[8,85,118,145,178,204,234,255,277,299],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":47,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":84},"100491983","phase-2-e7-tcr-t-cell-immunotherapy-for-human-papillomavirus-hpv-associated-cancers-100491983",false,"NCT05686226","E7 TCR-T Cell Immunotherapy for Human Papillomavirus (HPV) Associated Cancers","A Phase II Trial of T Cell Receptor Gene Therapy Targeting Human Papillomavirus ( HPV) 16 E7 for HPV-Associated Cancers","Inclusion Criteria: Subjects must meet all the following criteria to participate in this study.\n\n1. Histologically or cytologically confirmed metastatic or refractory\u002Frecurrent HPV-16+ cancer.\n2. Tumor and\u002For blood with HPV16 genotype as determined by testing performed in a Clinical Laboratory Improvement Amendments (CLIA) certified laboratory.\n3. HLA-A\\*02:01 allele as determined by testing performed in a CLIA certified laboratory. Participants may be enrolled based on low resolution typing (i.e., HLA-A\\*02) but the HLA-A\\*02:01 allele type must be confirmed prior to apheresis.\n4. Measurable disease as assessed by RECIST Criteria Version 1.1.\n5. Age ≥ 18 years.\n6. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 at screening.\n7. Must have received prior first line standard therapy or have declined standard therapy.\n8. Standard treatment options for first and second-line therapy must be presented and formally declined (Appendix VII).\n9. Patients with three or fewer brain metastases that have been treated with surgery or stereotactic radiosurgery are eligible. Lesions that have been treated with stereotactic radiosurgery must be clinically stable for one month before protocol treatment. Patients must be fully recovered from surgery.\n10. Negative pregnancy test for women under 55 and all women who have had a menstrual period in the last 12 months. A pregnancy test is not required for women who have had a bilateral oophorectomy or hysterectomy.\n11. Men and women of child-bearing potential must agree to use adequate contraception (i.e., intrauterine device, hormonal barrier method of birth control, abstinence, tubal ligation, or vasectomy) prior to study entry and for four months after treatment. Should a woman become pregnant or suspect she is pregnant while she is participating in this study, she should inform her treating physician immediately.\n12. Seronegative for HIV antibody, hepatitis B antigen (HBsAg), and hepatitis C antibody. If a hepatitis C antibody test is positive, then testing for antigen by RT-PCR for hepatitis C (HCV) RNA must be negative.\n13. Participants must have organ and marrow function as defined below:\n\n    1. Leukocytes \\> 3,000\u002FmcL\n    2. Absolute neutrophil count \\> 1,500\u002FmcL\n    3. Platelets \\> 100,000\u002FmcL\n    4. Hemoglobin \\> 9.0 g\u002FdL\n    5. Total bilirubin within normal institutional limits except in participants with Gilbert's Syndrome who must have a total bilirubin \\\u003C 3.0 mg\u002FdL.\n    6. Serum aspartate transferase (AST) (SGOT)\u002Falanine transaminase (ALT) (SGPT) \\\u003C 2.5 x upper limit of normal (ULN)\n    7. Calculated creatinine clearance (CrCl) \\>50 mL\u002Fmin\u002F1.73 m2 for participants with creatinine levels above institutional normal (by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation).\n    8. International normalized ratio (INR) or activated partial thromboplastin time (aPTT) ≤1.5 X ULN unless the subject is receiving anticoagulant therapy. Subjects on anticoagulant therapy must have a PT or aPTT within therapeutic range and no history of severe hemorrhage.\n14. More than four weeks must have elapsed since any prior systemic therapy at the time the patient receives the E7 TCR cells. Adverse events from prior therapy must have resolved to ≤ grade 1 according to CTCAE Version 5.0 or have demonstrated clinical stability for the protocol.\n15. Participants must be able to understand and be willing to sign the written informed consent document.\n16. Participants must agree to participate in Rutgers protocol 192103 (Pro2021002307) for gene therapy long term follow up and in Rutgers protocol 192002 (Pro2021000281) or NIH protocol 16C0061 (Rutgers 192202) for biospecimen collection study.\n\nNote: Participants may have undergone minor surgical procedures with the past three weeks, as long as all toxicities have recovered to Grade 1 or less.\n\nExclusion Criteria: Subjects who meet any of the following criteria will be excluded from participation in this study:\n\n1. Uncontrolled intercurrent illness such as active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations at the time of treatment that would limit compliance with study requirements.\n2. History of severe allergic reactions to compounds of similar chemical or biological composition to agents used in this study.\n3. History of coronary revascularization or ischemic symptoms unless patient has a normal cardiac stress test.\n4. Documented LVEF of less than or equal to 45% tested. The following participants will undergo cardiac evaluations:\n\n   1. Clinically significant atrial and\u002For ventricular arrhythmias including but not limited to: atrial fibrillation, ventricular tachycardia, second or third degree heart block or\n   2. Age ≥ 50 years old\n5. Participants with baseline screening pulse oxygen level of ≤ 92% on room air will not be eligible. If the underlying cause of hypoxia improves, then they may be reevaluated.\n6. Subjects with HLA-A\\*02:01 damaging mutation or allele loss detected by clinical or research genomic profiling will not be eligible.\n7. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with E7 TCR T cells, breastfeeding should be discontinued if the mother is treated with E7 TCR T cells. These potential risks may also apply to other agents used in this study.\n8. Participants with a systemic immunodeficiency including acquired deficiency such as HIV or primary immunodeficiency such as Severe Combined Immunodeficiency Disease are ineligible. The experimental treatment being evaluated in this protocol depends on an intact immune system. Participants who have decreased immune competence may be less responsive to the treatment.\n9. Participants on immunosuppressive drugs including corticosteroids unless meeting criteria outlined in Section 6.1 (Prohibited Medications).\n10. Participants with potentially severe autoimmune diseases such as Crohn's disease, ulcerative colitis, rheumatoid arthritis, autoimmune hepatitis, autoimmune pancreatitis, or systemic lupus erythematosus are not eligible. Patients with less severe autoimmune diseases such as hypothyroidism, vitiligo, and other minor autoimmune disorders are eligible.\n11. Participants with prior or concurrent malignancy whose natural history or treatment is unlikely to interfere with the safety or efficacy assessments of the investigational regimen are eligible for this trial. Examples include, but are not limited to:\n\n    1. Carcinoma in situ\n    2. Cutaneous skin cancers requiring only local excision\n    3. Low grade non-muscle invasive bladder cancer\n    4. Low grade prostate cancer\n\n    Participants with prior or concurrent malignancy that do not meet the above criteria are excluded.\n12. Subjects who received a live vaccine within 30 days prior to enrollment are not eligible.\n13. Determination by the Principal Investigator that participation is not in the best interest of the research subject or may jeopardize the safety of the subject or integrity of the clinical trial data.\n14. Current treatment with another investigational agent.","ALL","18 Years",{"count":19,"type":20},20,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","This is a phase II clinical trial to assess the clinical activity of immunotherapy with E7 TCR-T cells for metastatic HPV-associated cancers. HPV-associated cancers in include cervical, throat, penile, vulvar, vaginal, anal, and other cancers. Participants will receive a conditioning regimen, E7 TCR-T cells, and aldesleukin. Clinical response to treatment will be determined.",[26,27,28,29,30,31,32,33,34,35,36,37,38,39,40,41,42,43,44,45,46],"Cervical Cancer","Throat Cancer","Oropharynx Cancer","Anal Cancer","Vulva Cancer","Vaginal Cancer","Penile Cancer","Metastatic Cancer","HPV-Related Malignancy","HPV-Related Carcinoma","HPV-Related Cervical Carcinoma","HPV-Related Squamous Cell Carcinoma","HPV-Related Adenocarcinoma","HPV Positive Oropharyngeal Squamous Cell Carcinoma","HPV-Associated Vaginal Adenocarcinoma","HPV-Related Adenosquamous Carcinoma","HPV-Related Endocervical Adenocarcinoma","HPV-Related Anal Squamous Cell Carcinoma","HPV-Related Penile Squamous Cell Carcinoma","HPV-Related Vulvar Squamous Cell Carcinoma","HPV Positive Rectal Squamous Cell Carcinoma",[48,49,50,51,52,53,54,55,56,57,58,59,60,61,62,63,64,65,66,67,68,69,70,71],"Chimeric antigen receptors (CAR-T)","Tumor infiltrating lymphocyte","TCR-T","immunotherapy","T cell","adoptive cell therapy","cellular therapy","gene therapy","human papillomavirus","HPV","E7","T cell receptor","TCR","E7 TCR","lymphocyte","cell therapy","cervical cancer","oropharyngeal cancer","anal cancer","vulvar cancer","vaginal cancer","penile cancer","tumor infiltrating lymphocytes (TIL)","TIL therapy","RECRUITING","2026-06-10",{"date":75,"type":76},"2026-06-12","ACTUAL",{"date":78,"type":76},"2023-03-07",{"date":80,"type":20},"2027-01-01",{"name":82,"class":83},"Christian Hinrichs","OTHER",3,{"id":86,"slug":87,"hasResults":11,"nctId":88,"briefTitle":89,"officialTitle":90,"acronym":91,"eligibilityCriteria":92,"healthyVolunteers":11,"sex":93,"minAge":17,"maxAge":4,"enrollmentInfo":94,"targetDuration":4,"studyType":21,"phases":96,"briefSummary":98,"conditions":99,"keywords":4,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":108,"lastUpdatePostDateStruct":109,"startDateStruct":111,"completionDateStruct":113,"leadSponsor":115,"locationsCount":117},"100554166","danish-vulva-cancer-recurrence-study-100554166","NCT06495554","Danish Vulva Cancer Recurrence Study","The Value of Patient-reported Outcome Measure Assessment and Circulating Tumor-DNA to Detect Early Relapse During Surveillance in Women With Vulva Cancer","DaVulvaRec","Inclusion Criteria:\n\n* Primary or recurrent biopsy-verified squamous cell carcinoma of the vulva\n* ≥ 18 years of age\n* Able to understand oral and written information in Danish\n\nExclusion Criteria:\n\n* Active treatment for concurrent cancer and\u002For dissemination of concurrent cancer","FEMALE",{"count":95,"type":20},1295,[97],"NA","The overall aim is to investigate different aspects of recurrence detection in women with vulva cancer (VC) to identify optimal treatment- and surveillance programs.\n\nDaVulvaRec is a Danish nationwide multicenter study with patient inclusion from Aarhus University Hospital and Rigshospitalet, Denmark. Applying a mixed method research design, the investigators will collect and analyze patient-reported outcome measures in combination with procedural data to evaluate symptomatology and map actions taken during the patient's pathway from primary disease to recurrence. Furthermore, the investigators aim to examine if circulating tumor-DNA (ctDNA) can be detected in liquid biopsies from VC patients. All patients will be followed for two years or until recurrence. Patient-reported outcome measures will be completed every four months during surveillance, and liquid biopsies will be collected prospectively for later analyses.\n\nTotal number of patients to be included is 295 according to a power calculation. All patients in the clinical study will be included in the intervention group, while data on a historical control group will be obtained from The Danish Gynecological Cancer Database. Hence, the control group will consist of 1000 VC patients diagnosed between 2011-2022.\n\nHypotheses:\n\n* All patients with VC will have specific tumor markers in the primary tumor that will be detectable in liquid biopsies as ctDNA at the time of diagnosis.\n* Measurement of ctDNA after primary treatment and during surveillance will allow detection of residual disease, improve allocation for adjuvant treatment, and will allow early detection of recurrent VC.\n* Proactive use of repeated PROM assessments in combination with procedural actions during surveillance will allow early detection of recurrent VC and early identification of late effects after treatment.",[30,100,101,102,103,104,105,106,107],"Vulva Neoplasm","Vulvar Cancer","Vulva Disease","Vulvar Neoplasms","Vulvar Diseases","PROM","Circulating Tumor DNA","Survivorship","2026-04-28",{"date":110,"type":76},"2026-04-29",{"date":112,"type":76},"2024-08-15",{"date":114,"type":20},"2030-12-31",{"name":116,"class":83},"University of Aarhus",2,{"id":119,"slug":120,"hasResults":11,"nctId":121,"briefTitle":122,"officialTitle":123,"acronym":124,"eligibilityCriteria":125,"healthyVolunteers":11,"sex":93,"minAge":17,"maxAge":4,"enrollmentInfo":126,"targetDuration":4,"studyType":21,"phases":128,"briefSummary":129,"conditions":130,"keywords":131,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":135,"lastUpdatePostDateStruct":136,"startDateStruct":138,"completionDateStruct":140,"leadSponsor":142,"locationsCount":144},"100615306","phase-2-pembrolizumab-plus-lenvatinib-in-vulvar-cancer-patients-mito-vulva-01-100615306","NCT07290894","Pembrolizumab Plus Lenvatinib in Vulvar Cancer Patients: MITO VULVA-01","Pembrolizumab Plus Lenvatinib in Vulvar Cancer Patients: MITO VULVA-01 Study.","MITO VULVA-01","Inclusion Criteria:\n\nTarget subject population Inclusion Criteria\n\n1. Signed informed consent prior to any study specific procedure;\n2. Female, age ≥ 18 years at time of signing informed consent;\n3. Patients with histologically or cytologically confirmed unresectable squamous cell carcinoma, adenocarcinoma and mixed histology (adenosquamous) of the vulva, defined as:\n\n   1. T2 or T3 primary tumors (N0-3, M0) not amenable to surgical resection by standard radical vulvectomy (Cohort A) OR\n   2. recurrent or de novo metastatic chemotherapy-naive vulvar squamous cell carcinoma, adenocarcinoma and mixed histology (adenosquamous) of the vulva, (Cohort B) OR\n   3. recurrent squamous cell carcinoma of the vulva after primary chemoradiation or patients with metastatic squamous cell carcinoma, adenocarcinoma and mixed histology (adenosquamous) of the vulva in progression to a chemotherapy-based treatment (Cohort C)\n4. At least 1 measurable target lesion according to RECIST 1.1;\n5. Patients must have a life expectancy ≥ 16 weeks;\n6. ECOG performance status of 0 to 1;\n7. Adequately controlled blood pressure (BP) with or without antihypertensive medications, defined as BP ≤140\u002F90 mmHg at Screening and no change in antihypertensive medications within 1 week before the Cycle 1\u002FDay 1;\n8. Patient must provide formalin fixed paraffin embedded (FFPE), archival tumor samples, from primary tumor surgery or biopsy of primary tumor or metastases. The samples must be collected before any systemic treatment. (chemotherapy-naïve patients). A quality control analysis of samples will be performed before patient's enrollment. Only patients with adequate tumor samples will be enrolled.\n9. Patient must be able to take oral medications;\n10. Patients must have normal organ and bone marrow function measured as defined below:\n\n    * Haemoglobin ≥ 10.0 g\u002FdL with no blood transfusion in the past 28 days\n    * Absolute neutrophil count (ANC) ≥ 1.5 x 109\u002FL\n    * Aspartate aminotransferase (AST) (Serum Glutamic Oxaloacetic Transaminase (SGOT)) \u002F Alanine aminotransferase (ALT) (Serum Glutamic Pyruvate Transaminase (SGPT)) ≤ 2.5 x institutional upper limit of normal unless liver metastases are present in which case they must be ≤ 5x ULN\n    * Patients must have creatinine clearance estimated of ≥51 mL\u002Fmin using the Cockcroft-Gault equation or based on a 24 hour urine test: Estimated creatinine clearance = (140-age \\[years\\]) x weight (kg)(x F)a serum creatinine (mg\u002FdL) x 72 (a where F=0.85 for females)\n11. INR or PT aPTT\u002FPTT ≤1.5 × ULN unless participant is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants;\n12. Patient is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies:\n\n    1. Is not a Women of Childbearing Potential (WOCBP) or\n    2. Is a WOCBP and using a contraceptive method that is highly effective (with a failure rate of \\\u003C1% per year), with low user dependency, or be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis), as described in Appendix 1 during the intervention period and for at least 4 months post pembrolizumab or 30 days post lenvatinib, whichever occurs last. The investigator should evaluate the potential for contraceptive method failure (ie, noncompliance, recently initiated) in relationship to the first dose of study intervention\n13. A WOCBP must have a negative highly sensitive pregnancy test (urine or serum as required by local regulations) within 24 hours before the first dose of study intervention; Note: If a urine test cannot be confirmed as negative (eg, an ambiguous result), a serum pregnancy test is required. In such cases, the participant must be excluded from participation if the serum pregnancy result is positive;\n14. Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and other trial procedures.\n\nExclusion Criteria\n\n1. Patients with vulvar melanomas, sarcomas, vulvar Paget's disease, or basal cell carcinoma;\n2. Patients diagnosed with early-stage vulvar cancer that, according to the Investigator, can be treated with upfront curative surgery;\n3. Patients who have received any systemic anticancer therapy for vulvar cancer, anti-VEGF therapy, or any systemic investigational anticancer agent including radiotherapy (Cohort A and B); patients who have received any further systemic therapy for advanced disease after progression to a first-line platinum-based chemotherapy (Cohort C);\n4. Received a live vaccine or live attenuated within 30 days of planned start of study treatment (Cycle 1\u002FDay 1). Note: The killed virus vaccines (ie seasonal influenza vaccines for injection are allowed);\n5. Has preexisting ≥Grade 3 gastrointestinal or non-gastrointestinal fistula;\n6. Active infection (any infection requiring systemic treatment);\n7. Subjects known to be positive for Human Immunodeficiency Virus (HIV);\n8. Patients with known active hepatitis (i.e. Hepatitis B or C)\n\n   * Active hepatitis B virus (HBV) is defined by a known positive HBV surface antigen (HBsAg) result. Patients with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody and absence of HBsAg) are eligible;\n   * Patients positive for hepatitis C virus (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV RNA;\n9. Subjects with a diagnosis of immunodeficiency or who are receiving systemic steroid therapy (dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study medications;\n10. Active autoimmune disease that has required systemic treatment in past 2 years (ie, with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment;\n11. Patients unable to swallow orally administered medication;\n12. Patients receiving any systemic chemotherapy or radiotherapy (except for palliative reasons) within 3 weeks prior to study treatment;\n13. Major surgery within 3 weeks of starting study treatment and patients must have recovered from any effects of major surgery;\n14. Breast feeding women;\n15. Known active CNS metastases and\u002For carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable, (ie, without evidence of progression) for at least 4 weeks by repeat imaging (Note: The repeat imaging should be performed during study Screening.), clinically stable, and without requirement of steroid treatment for at least 14 days before the first dose of study intervention. Note: Participants with known untreated, asymptomatic brain metastases (ie, no neurological symptoms, no requirement for corticosteroids, no or minimal surrounding edema, and no lesion \\>1.5 cm) may participate but will require regular imaging of the brain as a site of disease;\n16. Other malignancy unless curatively treated with no evidence of disease for ≥5 years except: adequately treated non-melanoma skin cancer, curatively treated in situ cancer of the cervix, ductal carcinoma in situ (DCIS), Stage 1, grade 1 endometrial carcinoma\n17. Prolongation of QTcF interval to ≥480 msec;\n18. LVEF below of the institutional (or local laboratory), normal range, as determinated, by MUGA or ECHO;\n19. Participation in another clinical study with an investigational product during the last 3 months;\n20. Subjects who have not recovered adequately from any toxicity from other anti- cancer treatment regimens and\u002For complications from major surgery prior to starting therapy. Note: Withhold lenvatinib for at least 1 week prior to elective surgery. Do not administer for at least 2 weeks following major surgery and until adequate wound healing;\n21. Significant cardiovascular impairment including: history of congestive heart failure greater than New York Heart Association (NYHA) Class II, unstable angina, myocardial infarction, cerebro vascular accident\u002Fstroke, within 12 months of the first dose of study drug, or cardiac arrhythmia associated with hemodynamic instability. Medically controlled arrhytmia would be permitted;\n22. Bleeding or thrombotic disorders or subjects at risk for severe hemorrhage. Radiographic evidence of tumor invasion\u002Finfiltration of major blood vessels (e.g. carotid artery) or intratumoral cavitation. Note: The degree of major blood vessel should be considered because of the potential risk of severe hemorrhage associated with tumor shrinkage\u002Fnecrosis following lenvatinib therapy;\n23. Radiographic evidence of tumor invasion\u002Finfiltration of major blood vessels (e.g. carotid artery) or intratumoral cavitation. Note: The degree of major blood vessel should be considered because of the potential risk of severe hemorrhage associated with tumor shrinkage\u002Fnecrosis following lenvatinib therapy.\n24. History of arterial tromboembolism within 12 months of start the study;\n25. Active hemoptysis (bright red blood of at least 0.5 teaspoon) within 3 weeks prior to the first dose of study drug;\n26. Urine protein ≥1 g\u002F24 hours. Note: Participants with proteinuria ≥2+ (≥100 mg\u002FdL) on urine dipstick testing (urinalysis) will undergo 24-hour urine collection for quantitative assessment of proteinuria;\n27. GI malabsorption or any other condition that might affect the absorption of Lenvatinib;\n28. An allogenic tissue\u002Fsolid organ transplant;\n29. History of (noninfectious) pneumonitis\u002Finterstizial lung disease (ILD) that require steroids or current pneumonitis\u002F interstitial lung disease;\n30. Known psychiatric disorder or substance abuse that would interfere with participant ability to cooperate with the requirement of the study.\n31. Has received prior therapy with an anti-PD1, anti PD-L1 or anti PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX 40, CD137).",{"count":127,"type":20},80,[23],"MITO VULVA-1 is a prospective, single arm, multi-cohorts, phase II trial that aims to assess the activity and the safety of Lenvatinib plus Pembrolizumab in patients with vulvar cancer. 80 patients will be overall enrolled in the study.Three cohorts are planned",[30],[67,132,133,134],"pambrolizumab","lenvatinib","Phase II trial","2026-04-01",{"date":137,"type":76},"2026-04-02",{"date":139,"type":76},"2026-03-12",{"date":141,"type":20},"2031-10",{"name":143,"class":83},"National Cancer Institute, Naples",1,{"id":146,"slug":147,"hasResults":11,"nctId":148,"briefTitle":149,"officialTitle":150,"acronym":4,"eligibilityCriteria":151,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":152,"enrollmentInfo":153,"targetDuration":4,"studyType":21,"phases":155,"briefSummary":157,"conditions":158,"keywords":164,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":168,"lastUpdatePostDateStruct":169,"startDateStruct":171,"completionDateStruct":173,"leadSponsor":175,"locationsCount":177},"100626257","phase-1-carbon-nanoparticle-loaded-iron-in-the-treatment-of-advanced-solid-tumor-100626257","NCT07433283","Carbon Nanoparticle-Loaded Iron in the Treatment of Advanced Solid Tumor","A Phase Ib\u002FIIa Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Profile, and Preliminary Efficacy of Intratumoral Injection of Carbon Nanoparticle-Loaded Iron Suspension Injection [CNSI-Fe(II)] With Multiple Administrations in Subjects With Advanced Solid Tumors","Inclusion Criteria:\n\nPatients must meet all of the following criteria to be eligible:\n\n1. Understand and voluntarily sign the written informed consent form (ICF), be willing and able to comply with all trial requirements;\n2. Male or female aged 18\\~80 years old (including cut-off value) at the time of signing the ICF;\n3. Stage Ib: patients with advanced solid tumors confirmed by histology or cytology, and the current standard therapy is ineffective (disease progression after treatment or treatment is not tolerated) or there is no effective standard treatment, such as soft tissue sarcoma, refractory thyroid cancer, colorectal cancer, pancreatic cancer, breast cancer, gastric cancer, cervical cancer, lung cancer, head and neck cancer, liver cancer, bile duct cancer, kidney cancer, prostate cancer, vulvar cancer, etc.; Note: Subjects with advanced solid tumors whose disease progresses due to no standard therapy for any reason, or advanced solid tumors whose disease has progressed after receiving the first course of standard therapy for tumor types that are not sensitive to existing standard therapies (e.g., pancreatic cancer, undifferentiated thyroid cancer, sarcoma, etc.) can be included.\n4. At least one measurable lesion according to RESICT v1.1 and the lesion has not previously undergone radiotherapy (unless the lesion has clearly progressed after radiotherapy) and has not undergone a tissue biopsy within 7 days prior to screening;\n5. Have injectable lesions (such as direct injection or assisted injection by medical imaging instruments), which are judged by the investigator to be suitable for repeated intratumoral injection;\n6. The ECOG score within 7 days before the first dose is 0\\~1 points;\n7. Expected survival ≥ 3 months;\n8. Adverse drug reactions (ADRs) caused by prior therapy have recovered to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 criteria grade 1 and below before screening (alopecia, grade 2 or below peripheral neurotoxicity, etc., except for toxicities judged by the investigator to be of low safety risk);\n9. Left ventricular ejection fraction (LVEF) ≥50%;\n10. Within 7 days prior to the first dose, adequate hematologic and end-organ function with laboratory tests meeting the following criteria:\n\n    haematology No treatment with granulocyte colony-stimulating factor (G-CSF) within 14 days prior to hematology laboratory tests, and absolute neutrophil count (ANC) ≥ 1.5×109\u002FL; Have not been treated with platelet transfusion or interleukin-11 (IL-11) or recombinant human thrombopoietin injection before hematological laboratory examination, and the platelet count (PLT) ≥ 90×109\u002FL; No blood transfusion or erythropoietin within 14 days prior to hematology laboratory tests, and hemoglobin (Hb) ≥ 90 g\u002FL; Kidney function Serum creatinine (Cr) ≤ 1.5× upper limit of normal (ULN) or 50 mL\u002Fmin (Cr only) calculated using the Cockcroft-Gault formula (Cr) 50 mL\u002Fmin (Cr ≥\\> only). 1.5 Calculate Ccr when ×ULN); Liver function TBIL ≤ 1.5× ULN (3.0 ≤× ULN for subjects with Gilbert's syndrome or liver metastases);\n\n    AST, ALT, and ALP≤3×ULN, and subjects with confirmed liver metastases or bone metastases must meet the following conditions:\n\n    Subjects with confirmed liver metastases: AST and ALT≤5×ULN; Subjects with confirmed bone metastases: ALP≤5×ULN; serum albumin≥ 2.8 g\u002FdL; Coagulation function International normalized ratio (INR) or prothrombin time (PT) and aPTT ≤1.5×ULN; Note: Subjects receiving anticoagulant medication are allowed to prolong their INR, PT and aPTT if the injected lesion is in the skin and\u002For subcutaneous, because excessive bleeding can be controlled by applying direct pressure, at the discretion of the investigator; Subjects receiving anticoagulant therapy are advised to discontinue anticoagulant medication for at least 1 week before deep lesion injection, at the discretion of the investigator.\n11. Female subjects of childbearing potential (WOCBP) who must have a negative serum pregnancy test result within 7 days prior to the first dose of study drug and a commitment to adequate and effective contraception or abstinence during treatment with study drug and for 6 months after the end of study drug treatment. In addition, female subjects must be non-lactating.\n\n    Note: WOCBP is defined as non-postmenopausal women who have experienced menarche but have not yet undergone sterilization surgery (hysterectomy or bilateral salpingectomy). Postmenopausal is defined as meeting any of the following conditions: (1) prior bilateral oophorectomy; (2) Age≥ 60 years old; (3) Age \\\u003C 60 years and have been out of menstruation for 12 months or more without chemotherapy and taking tamoxifen, toremifene and ovarian function suppression therapy; (4) If taking tamoxifen or toremiaphene and \\\u003C age 60 years, FSH and plasma estradiol levels must be in the postmenopausal range.\n\n    Hormone replacement therapy (HRT) may artificially suppress FSH levels in women and may require a washout period to return to physiological FSH levels. The duration of the washout period is one of the effects of the HRT type. The following washout period duration is recommended as a guideline, and the investigator should judge the results of the serum FSH level on his own.\n\n    vaginal hormonal preparations (drug rings, creams, gels) for at least 1 week; transdermal preparation for at least 4 weeks; Oral preparation for at least 8 weeks; Other parenteral preparations may require a washout period of up to 6 months. If the serum FSH level \\> 40 mIU\u002FmL during the washout period, a postmenopausal woman may be considered.\n12. Male subjects commit to adequate and effective contraception or abstinence during study drug treatment and for 6 months after the end of study drug treatment. In addition, male subjects must agree not to donate sperm during this period.\n\nExclusion Criteria:\n\nPatients meeting any of the following criteria cannot participate in this clinical study:\n\n1. Previous or current diseases with abnormal iron metabolism (except for subjects with iron deficiency anemia), such as thalassemia, fava bean disease (erythrocyte glucose-6-phosphate dehydrogenase deficiency), etc.;\n2. Signs of perforation of hollow viscera at the previous or current injection site;\n3. Previous or current injection site with local skin breakdown, redness, swelling, necrosis, bleeding, etc., which affects the injection of study drugs;\n4. Systemic chemotherapy, targeted therapy, anti-tumor biologic therapy, or immunotherapy within 3 weeks prior to the first dose of study drug; Prior radiotherapy within 14 days prior to the first dose of study drug (with the exception of central nervous system \\[CNS\\] radiotherapy, which requires a washout period of ≥ 28 days); Received traditional Chinese medicine with anti-tumor indications within 2 weeks before the first dose of the study drug;\n5. Major surgery within 4 weeks prior to the first dose of study drug or unhealed wounds, ulcers, or fractures (except for minor surgeries performed within 1 week and full recovery);\n6. Untreated or with active brain metastases, spinal cord compression, carcinomatous meningitis, or other evidence that the subject's brain or spinal cord metastases have not been controlled (except for those who have been treated and have stable symptoms, have been stable for at least 4 weeks before the first dose on imaging tests, and have no evidence of cerebral edema, and do not require glucocorticoid therapy);\n7. Uncontrolled or poorly controlled hypertension (e.g., systolic blood pressure \\> 160 mmHg or diastolic blood pressure \\> 100 mmHg);\n8. Uncontrolled tumor-related pain;\n9. Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage (once\u002Fmonth or more often);\n10. Active malignancy within 5 years prior to the first dose of study treatment, with the exception of non-melanoma skin cancer, localized prostate cancer, ductal carcinoma in situ or stage I uterine cancer, cervical carcinoma in situ, or carcinoma in situ of the breast that has received curative therapy;\n11. Vaccination with a live virus vaccine within 4 weeks prior to the first dose of study treatment; Note: Seasonal influenza vaccines for injection are usually inactivated influenza vaccines and are permitted; However, intranasal influenza vaccine is a live attenuated vaccine and is not allowed.\n12. Those with a history of immunodeficiency, including human immunodeficiency virus (HIV) positive or other acquired, congenital immunodeficiency diseases, or a history of organ transplantation;\n13. Active hepatitis B virus (HBV) infection (HBV DNA quantification \\>500 IU\u002FmL), hepatitis C virus (HCV) infection (HCV antibody positive and polymerase chain reaction \\[PCR\\] of HCV ribonucleic acid \\[RNA\\] exceeds ULN), positive anti-human immunodeficiency virus antibody (Anti-HIV). Those who meet any of the above items;\n14. Severe chronic or active infection (including tuberculosis infection, etc.) requiring systemic antibacterial, antifungal or antiviral therapy prior to the start of study treatment; Note: Subjects with viral hepatitis are allowed to receive antiviral therapy.\n15. History of severe cardiac insufficiency, stroke, or transient ischemic attack (TIA) within 6 months prior to enrollment. History of ventricular tachycardia or torsade de pointes. Any clinically important abnormalities in rhythm, conduction, or morphology of the resting ECG. Has clinically significant cardiac disease, including acute myocardial infarction, Class III or IV congestive heart failure (New York Heart Association classification, see Appendix 5 for details), unstable angina, or cardiac arrhythmia requiring treatment that occurred within 6 months prior to the first dose of study treatment. Note: Subjects with arrhythmias who are receiving anti-arrhythmic drugs and have a controlled heart rate rhythm on screening ECG can be enrolled.\n16. Have an active psychiatric disorder (schizophrenia, major depressive disorder, bipolar disorder, etc.);\n17. Subjects who are known to be allergic or intolerant to the active ingredient or excipient of the study drug;\n18. Have participated in other interventional clinical studies within 3 weeks prior to the start of study treatment administration (calculated from the first day after the last dose of the previous study, except for those who have not used interventional drugs or investigational medical devices);\n19. Other conditions judged by the investigator to be unsuitable for participation in this trial","80 Years",{"count":154,"type":20},54,[156,23],"PHASE1","Independently developed by Sichuan Yingrui Pharmaceutical Technology Co., Ltd., CNSI-Fe is an innovative anti-cancer drug with Fe2+ as the active ingredient, which exerts anti-tumor effects by regulating the ferroptosis pathway. CNSI-Fe intratumoral injection has the following three effects: 1. Nanocarbon can increase the content of hydrogen peroxide in tumor cells and tumor microenvironment, and is a reactive oxygen species that catalyzes hydrogen peroxide through the Fenton reaction of iron ions to produce \"ferroptosis\", which complements each other; 2. The adsorption of Fe2+ by nanocarbon can help Fe2+ better enter the cell, thereby exerting anti-tumor effects; 3. The lesion localization and lymphatic tracing functions of nanocarbon are retained. The combination of the regulatory mechanism of ferroptosis and the characteristics of nanocarbon particles has increased the advantages of new nanopharmaceuticals in cancer prevention and treatment.\n\nAt present, CNSI-Fe has carried out a first-in-human phase I clinical trial of dose escalation in subjects with advanced solid tumors in China, and has conducted safety and efficacy exploration in four dose groups, including: 30 mg, 60 mg, 90 mg, and 120 mg, and the overall safety and tolerability of the 16 subjects enrolled have been good, no obvious liver and kidney impairment and hematologic toxicity have been observed, and only one subject in the 90 mg dose group has a dose-limiting toxicity (DLT) event; Partial response (PR) was observed in 1 subject (30 mg group), complete tumor response (CR) was observed in 1 subject (60 mg group), and stable tumor (SD) was observed in 11 subjects (including 1 in the 30 mg group, 2 in the 60 mg group, 5 in the 90 mg group, and 3 in the 120 mg group), and the disease control rate (DCR) of the trial treatment was 87%. This Phase I clinical study is planned to continue dose exploration at 150 mg or higher.\n\nTherefore, based on the results of the Phase I clinical trial obtained, it is planned to conduct this Phase Ib\u002FIIa clinical study in subjects with advanced solid tumors in China to further evaluate the safety, tolerability, pharmacokinetic (PK) characteristics and preliminary efficacy of CNSI-Fe intratumoral injection and multiple administration, so as to provide a basis for clinical development in the later stage.",[159,160,161,162,163,26,30],"Tumor, Solid","Lung Cancer","Pancreas Cancer","Thyroid Cancer","Colorectal Cancer",[165,166,167],"Intratumoral Injection","Carbon Nanoparticle-Loaded Iron","Advanced Solid Tumor","2026-02-24",{"date":170,"type":76},"2026-02-25",{"date":172,"type":76},"2024-11-12",{"date":174,"type":20},"2026-12-31",{"name":176,"class":83},"Sichuan Enray Pharmaceutical Sciences Company",9,{"id":179,"slug":180,"hasResults":11,"nctId":181,"briefTitle":182,"officialTitle":183,"acronym":4,"eligibilityCriteria":184,"healthyVolunteers":11,"sex":93,"minAge":17,"maxAge":4,"enrollmentInfo":185,"targetDuration":4,"studyType":21,"phases":186,"briefSummary":187,"conditions":188,"keywords":191,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":195,"lastUpdatePostDateStruct":196,"startDateStruct":198,"completionDateStruct":200,"leadSponsor":202,"locationsCount":144},"100549320","3d-printed-custom-applicators-for-hdr-bt-disco-100549320","NCT06432478","3D Printed Custom Applicators for HDR BT (DISCO)","Study of 3D-printed Custom Applicators for Intracavitary HDR Gynaecological Brachytherapy (DISCO)","Inclusion Criteria:\n\n* Able to give informed consent\n* Patients indicated for intracavitary brachytherapy\n* FIGO stage I-IVA\n* ECOG 0-2\n* Primary endometrial cancer, primary vaginal cancer, primary vulva cancer, recurrent gynaecological cancer\n\nExclusion Criteria:\n\n* Pregnancy\n* Patients contraindicated for brachytherapy\n* Inflammatory bowel disease\u002Fhistory of adhesions\u002Fbowel obstruction\n* Renal transplant\u002Fhorseshoe kidney\n* Patients with significant LVSI or pelvic sidewall invasion\n* Patients requiring interstitial brachytherapy implants",{"count":5,"type":20},[97],"Intracavitary brachytherapy for gynaecological cancer currently use cylinder-type applicators or custom wax moulds to place a radioactive source in close proximity to the treatment area and provide highly conformal dose distributions. This study is a Phase IIa non-randomised interventional pilot trial that will investigate the feasibility of successfully treating patients with 3D-printed custom applicators.",[189,190,31,30],"Gynecologic Cancer","Endometrial Cancer",[192,193,194],"3D-printed applicator","Gynaecological Cancer","Brachytherapy","2026-02-04",{"date":197,"type":76},"2026-02-06",{"date":199,"type":76},"2023-11-24",{"date":201,"type":20},"2028-09",{"name":203,"class":83},"Royal North Shore Hospital",{"id":205,"slug":206,"hasResults":11,"nctId":207,"briefTitle":208,"officialTitle":208,"acronym":209,"eligibilityCriteria":210,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":211,"targetDuration":4,"studyType":21,"phases":213,"briefSummary":214,"conditions":215,"keywords":220,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":224,"lastUpdatePostDateStruct":225,"startDateStruct":227,"completionDateStruct":229,"leadSponsor":231,"locationsCount":233},"100287124","prospective-biobanking-study-in-cancer-patients-aiming-at-better-understand-the-link-between-the-molecular-alterations-of-the-tumor-itself-its-microenvironment-and-immune-response-scandare-100287124","NCT03017573","Prospective Biobanking Study in Cancer Patients Aiming at Better Understand the Link Between the Molecular Alterations of the Tumor Itself, Its Microenvironment and Immune Response (SCANDARE)","SCANDARE","Inclusion Criteria:\n\n1. Tumor types :\n\n   1. Newly diagnosed treatment-naïve ovarian cancer patients eligible for surgery or neoadjuvant chemotherapy\n   2. Newly diagnosed treatment-naïve triple-negative breast cancer patients eligible for surgery or neoadjuvant chemotherapy\n   3. Newly diagnosed treatment-naïve head and neck cancer patients eligible for surgery\n   4. Newly diagnosed treatment-naïve vulva cancer (all types) or cervical cancer patients with (1) stage Ia - IIa1 with nodal metastasis, postoperative positive margin or parametrial-vaginal involvement, and (2) stage ≥IIa2).\n   5. Newly diagnosed treatment-naïve sarcoma cancer patients (1) breast angiosarcoma or (2) uterine sarcoma eligible for surgery or systemic treatment\n2. Male or female patients ≥ 18 years of age\n3. Signed informed consent\n\nExclusion Criteria:\n\n1. Male or female patients ≤18 years old\n2. Patients with any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule\n3. Individually deprived of liberty or placed under the authority of a tutor\n4. Patients not affiliated to the Social Security System",{"count":212,"type":20},1050,[97],"SCANDARE is a prospective biobanking study on tumor (+\u002F- nodes), plasma and blood samples at different time points in ovarian, triple negative breast, Head and Neck Cancer, advanced stage treatment-naïve cervical or vulva cancer and sarcoma (breast angiosarcoma and uterine sarcoma) cancers. This study will allowed to identify new molecular and\u002For immunological biomarkers associated with clinical and biological features of the tumors. All patients will receive standard treatment according to the stage of the diseases and usual procédures.",[216,217,218,26,219,30],"Ovarian Cancer","Triple-Negative Breast Cancer","Head and Neck Cancer","Sarcoma",[221,222,223],"Immunological biomarkers","molecular profil","Circulating tumor DNA (ctDNA)","2026-01-30",{"date":226,"type":76},"2026-02-03",{"date":228,"type":76},"2017-01-06",{"date":230,"type":20},"2032-01-06",{"name":232,"class":83},"Institut Curie",6,{"id":235,"slug":236,"hasResults":11,"nctId":237,"briefTitle":238,"officialTitle":239,"acronym":4,"eligibilityCriteria":240,"healthyVolunteers":11,"sex":93,"minAge":17,"maxAge":4,"enrollmentInfo":241,"targetDuration":4,"studyType":242,"phases":4,"briefSummary":243,"conditions":244,"keywords":4,"overallStatus":245,"whyStopped":4,"lastUpdateSubmitDate":246,"lastUpdatePostDateStruct":247,"startDateStruct":249,"completionDateStruct":251,"leadSponsor":253,"locationsCount":144},"100518786","sln-mapping-and-icg-dye-for-vulvar-cancer-100518786","NCT06035068","SLN Mapping and ICG Dye for Vulvar Cancer","Sentinel Lymph Node Mapping and Detection With Indocyanine Green and Spy-Phi Handheld Camera Technology in Early-Stage Vulvar Cancer (PILOT)","Inclusion Criteria:\n\n* 18 years of age or older\n* Patients with early-stage SCC (diameter \\\u003C4 cm) of the vulva without suspicious lymph nodes at palpation or imaging who are planned for surgery at Tufts Medical Center.\n* Patients with squamous cell carcinoma, depth of invasion \\> 1mm\n* Patients with T1 or T2 tumors (FIGO staging) \\\u003C 4 cm, not encroaching in urethra or anus with clinically negative inguinofemoral lymph nodes\n* Localization and size of the tumor are such that perilesional injection of the tracers at three or four sites is possible\n* Preoperative imaging do not show enlarged (\\\u003C1.5 cm)\u002F suspicious nodes\n* Willing and able to give informed consent\n\nExclusion Criteria:\n\n* Inoperable tumors and tumors with diameter \\> 4 cm\n* Patients with inguinofemoral lymph nodes that are palpable on clinical exam suspicious for metastases or with cytologically proven inguinofemoral lymph node metastases\n* Radiologically enlarged (\\>1.5 cm) inguinofemoral lymph nodes\n* Patients with multifocal tumors\n* Pregnancy",{"count":5,"type":20},"OBSERVATIONAL","Doctors typically use blue dye to assist in locating and extracting lymph nodes for biopsy. However, this process can prove somewhat challenging for both patients and medical teams due to its need for extensive coordination and the assistance of a nuclear medicine team. Some studies have talked about using a different method to find these lymph nodes using a special dye called Indocyanine Green (ICG). This method involves shining a special camera on the skin. So far, no studies have directly compared the ICG method to the standard blue dye. The ICG camera could make things easier for patients and doctors, and more patients might choose to have their lymph nodes checked with this new method. The goal of our study is to see if using the ICG dye is just as good as the standard method of blue dye.",[30],"NOT_YET_RECRUITING","2025-09-23",{"date":248,"type":76},"2025-09-29",{"date":250,"type":20},"2025-11-01",{"date":252,"type":20},"2026-01",{"name":254,"class":83},"Tufts Medical Center",{"id":256,"slug":257,"hasResults":11,"nctId":258,"briefTitle":259,"officialTitle":260,"acronym":4,"eligibilityCriteria":261,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":262,"targetDuration":4,"studyType":21,"phases":264,"briefSummary":265,"conditions":266,"keywords":4,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":269,"lastUpdatePostDateStruct":270,"startDateStruct":272,"completionDateStruct":274,"leadSponsor":275,"locationsCount":144},"100557946","phase-1-scg142-tcr-t-cells-for-human-papillomavirus-associated-carcinomas-100557946","NCT06544720","SCG142 TCR-T Cells for Human Papillomavirus-Associated Carcinomas","A Phase 1 Clinical Study of Autologous TCR-T Cells (SCG142) Therapy for Advanced HPV Associated Carcinomas","Key Inclusion Criteria:\n\n1. Greater than or equal to 18 years of age\n2. HPV associated carcinomas\n3. Patients must have at least one measurable lesion defined by RECIST 1.1\n4. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1\n\nKey Exclusion Criteria:\n\n1. Active or uncontrollable infections or other active major medical illnesses of the cardiovascular, respiratory.\n2. Patients with active autoimmune diseases.\n3. Patient has a known active Hepatitis B or Hepatitis C.\n4. Other severe medical conditions that may limit subject\\'s participation in this trial.",{"count":263,"type":20},18,[156],"A multicenter, open, single arm dose escalation and dose expansion phase I study to evaluate the safety, tolerability, and efficacy of SCG142 TCR-T cells in Subjects with advanced HPV associated carcinomas.",[267,26,268,29,30,31,32,34],"Human Papillomavirus Associated Carcinomas","Head and Neck Cancers","2024-08-06",{"date":271,"type":76},"2024-08-09",{"date":273,"type":76},"2023-08-02",{"date":174,"type":20},{"name":276,"class":83},"The Affiliated Hospital of Qingdao University",{"id":278,"slug":279,"hasResults":11,"nctId":280,"briefTitle":281,"officialTitle":282,"acronym":283,"eligibilityCriteria":284,"healthyVolunteers":11,"sex":93,"minAge":17,"maxAge":4,"enrollmentInfo":285,"targetDuration":4,"studyType":242,"phases":4,"briefSummary":287,"conditions":288,"keywords":4,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":290,"lastUpdatePostDateStruct":291,"startDateStruct":293,"completionDateStruct":295,"leadSponsor":297,"locationsCount":144},"100528488","optical-guided-sentinel-node-biopsy-for-staging-of-vulvar-cancer-100528488","NCT06161428","Optical Guided Sentinel Node Biopsy for Staging of Vulvar Cancer","Optical Guided Sentinel Node Biopsy for Staging of Vulvar Cancer ( SENTIVUC II)","SENTIVUC II","Inclusion Criteria:\n\n* Patients with vulva cancer, tumor \\> 4 cm, multifocal tumor, or local recurrences in vulva\n\nExclusion Criteria:\n\n* Previous external irradiation of the vulva or groins\n* Former sentinel node or inguinal lymphadenectomy in the relevant groin\n* Known allergy to ICG or iodine\n* Patient is in active treatment for other cancer and\u002For disseminated disease",{"count":286,"type":20},100,"The aim of the study is to evaluate the feasibility of applying the SLN mapping technique in combination with FDG-PET\u002FCT imaging in women with vulva cancer tumour size \\>4 cm, multifocal tumors and local recurrences.",[30,289],"Sentinel Lymph Node","2023-12-07",{"date":292,"type":76},"2023-12-13",{"date":294,"type":76},"2023-05-01",{"date":296,"type":20},"2027-07-01",{"name":298,"class":83},"Rigshospitalet, Denmark",{"id":300,"slug":301,"hasResults":11,"nctId":302,"briefTitle":303,"officialTitle":304,"acronym":305,"eligibilityCriteria":306,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":307,"targetDuration":4,"studyType":242,"phases":4,"briefSummary":309,"conditions":310,"keywords":4,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":320,"lastUpdatePostDateStruct":321,"startDateStruct":323,"completionDateStruct":325,"leadSponsor":327,"locationsCount":144},"100518298","a-study-on-the-prevalence-of-clinically-useful-mutations-in-solid-tumor-characterized-by-next-generation-sequencing-methods-on-liquid-biopsy-analysis-popcorn-100518298","NCT06028724","A Study on the Prevalence of Clinically Useful Mutations in Solid Tumor Characterized by Next Generation Sequencing Methods on Liquid Biopsy Analysis (POPCORN)","A Prospective, Observational Study on the Prevalence of Clinically Useful Mutations in Solid Tumor Characterized by Next Generation Sequencing Methods on Liquid Biopsy Analysis (POPCORN)","POPCORN","Inclusion Criteria:\n\nPatients eligible for inclusion in this study have to meet all of the following criteria:\n\n* Patients, 18 years of age or older\n* Competent and able to comprehend, sign and date an Ethics Committee (EC) approved Informed Consent Form (ICF) before performance of any study-specific procedures or tests\n* Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures\n* Histologically proven diagnosis solid tumor\n* Diagnosis of advanced or locally advanced disease\n* Patients candidated to receive standard therapy in the following line:\n* first, second or third-line therapy for colon-rectal cancer in IV stage\n* first or second-line therapy for gastric cancer in IV stage\n* primary intent or first-line therapy for pancreatic cancer\n* first-line therapy for bile duct cancer\n* first or second-line therapy for hepatocarcinoma\n* first, second, third, fourth or fifth-line therapy for breast cancer in IV stage\n* chemotherapy for ovarian cancer in advanced stage (FIGO III-IV) and at the time of first relapse\n* first or second-line therapy for endometrial cancer in advanced stage (FIGO III-IV)\n* first or second-line therapy for advanced or locally advanced cervical cancer\n* therapy for locally advanced or first line therapy for metastatic vulva cancer\n* first, second or third-line therapy for melanoma (third-line therapy only in BRAF-mutated melanoma)\n\nExclusion Criteria:\n\n* Diagnosis of any secondary malignancy within the last 3 years, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ of the cervix.\n* Patients unable or unwilling to undergo as per protocol assessments at the four planned timepoints",{"count":308,"type":20},782,"The implementation of liquid biopsy in clinical practice has been favored by the rapid development of genome sequencing techniques designed to analyze mutations in ctDNA. Among these, the Next generation sequencing (NGS) is a technique that consists in sequencing several genomes in a short time span, collecting information about a wider range of genomic alterations, using small quantities of genetic material. It is used to identify potential circulating dynamic biomarkers of treatment sensitivity or resistance in a real word multi-pathology evaluation. In this way, defining the mutational status of clinical relevance genes in real world, as a predictive biomarker to identify those patients most likely to benefit from target therapy, offers the potential to optimize access to further therapies. The aim of this study is to evaluate the real-world prevalence of clinically useful mutations in patients who are receiving therapy for advanced and locally advanced solid tumor through liquid biopsy.",[311,167,312,313,314,315,316,317,318,216,190,26,30,319],"Solid Tumor","Locally Advanced Solid Tumor","Colon Rectal Cancer","Gastric Cancer","Pancreatic Cancer","Bile Duct Cancer","Hepatocarcinoma","Breast Cancer","Melanoma","2023-09-08",{"date":322,"type":76},"2023-09-13",{"date":324,"type":76},"2023-05-26",{"date":326,"type":20},"2030-05-31",{"name":328,"class":83},"Centro di Riferimento Oncologico - Aviano"]