[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"brca-2-gene-mutation\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:brca-2-gene-mutation":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,58],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":32,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":47,"lastUpdatePostDateStruct":48,"startDateStruct":51,"completionDateStruct":53,"leadSponsor":55,"locationsCount":5},"100651725","ovarian-cancer-liquid-biopsy-for-early-assessment--detection-in-individuals-with-brca12-pathogenic-variants-100651725",false,"NCT07764744","Ovarian Cancer Liquid Biopsy for Early Assessment & Detection in Individuals With BRCA1\u002F2 Pathogenic Variants","Ovarian Cancer Liquid Biopsy for Early Assessment & Detection (OC-LEAD)","OC-LEAD","Inclusion Criteria:\n\nCohort A participants must meet all of the following criteria:\n\n1. Age ≥ 35 years (based on current National Comprehensive Cancer Network guidelines35 for risk-reducing gynecologic surgery) with no upper age limit\n2. Confirmed germline PV or likely PV in the BRCA1 or BRCA2 genes, documented by CLIA-certified genetic testing.\n3. Scheduled to undergo risk-reducing gynecologic surgery (salpingo-oophorectomy or salpingectomy with or without hysterectomy) at the study site.\n4. Willing and able to provide informed consent in English This initial phase is limited to English-speaking participants. This limitation is due to feasibility considerations for initial qualitative instrument validation; future phases will incorporate translated materials\n\n   Cohort B participants must meet all of the following criteria:\n5. Age ≥ 35 years with no upper age limit.\n6. STIC lesion previously identified on surgical pathology within the prior 10 years.\n7. Willing and able to undergo baseline and annual research blood draws for up to 10 years following STIC lesion diagnosis.\n8. Willing and able to provide informed consent in English\n\nExclusion Criteria:\n\nCohort A:\n\n1. Pregnant or breastfeeding at the time of enrollment.\n2. Prior removal of bilateral fallopian tubes and\u002For bilateral ovaries.\n3. Active diagnosis of cancer.\n4. Prior or active diagnosis of epithelial ovarian, fallopian tube, or primary peritoneal cancer at the time of consent.\n5. Patients with a history of cancer are eligible when \\> 2 years no evidence of disease.\n6. Inability to provide informed consent.\n7. Concurrent participation in another interventional trial that may confound study outcomes.\n\nCohort B:\n\n1. Pregnant or breastfeeding at the time of enrollment.\n2. Active diagnosis of cancer.\n3. Prior or active diagnosis of epithelial ovarian, fallopian tube, or primary peritoneal cancer at the time of consent (prior STIC lesion is NOT a contraindication to enrollment).\n4. Patients with a history of cancer are eligible when \\> 2 years no evidence of disease.\n5. Inability to provide informed consent.\n6. Concurrent participation in another interventional trial that may confound study outcomes.","FEMALE","35 Years",{"count":20,"type":21},70,"ESTIMATED","INTERVENTIONAL",[24],"NA","The goal of this clinical study is to evaluate the feasibility and acceptability of the Galleri multi-cancer early detection blood test in people with BRCA1 or BRCA2 gene changes who are at high risk for ovarian cancer. The study will also explore how well the test detects ovarian cancer or related precancerous conditions.\n\nThe main questions it aims to answer are:\n\n* Is it feasible to incorporate the Galleri blood test into the care of people at high \\* risk for ovarian cancer?\n* Is the Galleri blood test acceptable to participants?\n* How well does the Galleri blood test identify ovarian cancer or related precancerous conditions?\n\nParticipants will:\n\n* Receive the Galleri blood test.\n* Complete questionnaires about their experience with the test.\n* Some participants will also complete an interview about their experiences and preferences.\n* Continue with their planned standard medical care, including surgery or follow-up visits, as appropriate.",[27,28,29,30,31],"Ovarian Neoplasms","BRCA 1 Gene Mutation","BRCA 2 Gene Mutation","Serous Tubal Intraepithelial Carcinoma","Early Detection of Ovarian Cancer",[33,34,35,36,37,38,39,40,41,42,43,44,45],"Ovarian cancer","Liquid biopsy","Galleri","Multi-cancer early detection","BRCA1","BRCA2","Hereditary breast and ovarian cancer syndrome","Serous tubal intraepithelial carcinoma (STIC)","Risk-reducing salpingo-oophorectomy","Early cancer detection","Hereditary cancer","Cancer screening","Implementation science","NOT_YET_RECRUITING","2026-08-10",{"date":49,"type":50},"2026-08-14","ACTUAL",{"date":52,"type":21},"2026-08",{"date":54,"type":21},"2039-07",{"name":56,"class":57},"Weill Medical College of Cornell University","OTHER",{"id":59,"slug":60,"hasResults":11,"nctId":61,"briefTitle":62,"officialTitle":62,"acronym":63,"eligibilityCriteria":64,"healthyVolunteers":11,"sex":17,"minAge":65,"maxAge":4,"enrollmentInfo":66,"targetDuration":4,"studyType":22,"phases":68,"briefSummary":69,"conditions":70,"keywords":77,"overallStatus":84,"whyStopped":4,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":94},"100615410","a-prospective-cohort-study-of-handx---assisted-endoscopic-mastectomy-feasibility-and-safety-athena-i-study-100615410","NCT07292246","A Prospective CohorT Study of HandX - Assisted ENdoscopic MAstectomy: Feasibility and Safety (ATHENA I Study)","ATHENA I","Inclusion Criteria:\n\n* Female sex\n* Age ≥ 18 years old\n* Indication for therapeutic or prophylactic (risk-reducing) mastectomy for:\n\n  1. early invasive breast cancer (Clinical Stage I-II at diagnosis) undergoing primary surgery\n  2. early invasive breast cancer (Clinical Stage I-II at diagnosis) undergoing surgery post systemic (neoadjuvant) therapy with clinical evidence of partial or complete response\n  3. ductal carcinoma in situ (DCIS), or\n  4. BRCA or other breast cancer - related genetic mutation carriers, or\n  5. high risk for development of breast cancer.\n* Breast volume: cup sizes A to C as defined by underwear size, expected implant volume \\\u003C550cc and glandular ptosis not exceeding Grade I Regnault's classification.\n* ECOG \u002F WHO Performance Status \\\u003C2\n* Subject with signed and dated informed consent form\n\nExclusion Criteria:\n\n* Chest wall or skin invasion\n* Extended lymph node involvement at diagnosis (cN2)\n* Inflammatory breast cancer\n* Tumor distance from nipple - areola complex \\\u003C1cm on imaging studies\n* Active smoking\u002Fnicotine use within 4 weeks pre-op (combustible tobacco, vaping, nicotine pouches, NRT)\n* BMI \\>35\n* High risk patients with severe and poorly controlled co-morbid conditions (including but not limited to diabetes, heart disease, renal failure or liver dysfunction)\n* Pregnancy or breastfeeding\n* Psychiatric, addictive, or any disorders which compromise the ability to give informed consent for participation in this study\n* Subject without signed and dated informed consent form","18 Years",{"count":67,"type":21},15,[24],"This study aims to learn whether a handheld robotic device, called the HandX, can help surgeons safely perform a minimally invasive nipple-sparing mastectomy. This type of mastectomy uses a small incision at the side of the breast to remove breast tissue while keeping the skin and nipple in place. The goal is to lower scarring, improve comfort, and support good cosmetic results after surgery.\n\nParticipants in this study will already be planning to have a therapeutic or preventive mastectomy with immediate implant-based reconstruction. All surgeries are done at Mediterraneo Hospital in Greece.\n\nDuring the operation, surgeons use the HandX device to assist with the endoscopic dissection. Researchers will collect information about how long the surgery takes, whether the planned approach can be completed without switching to open surgery, and whether any surgical complications occur. They will also check healing, infection, and implant-related problems for up to 365 days after surgery. Participants will complete the BREAST-Q questionnaire before surgery and at several times after surgery to share their views on comfort, well-being, and cosmetic outcomes.\n\nAbout 15 participants will take part. The results will help researchers understand whether this approach is practical and safe, and whether it should be studied further in a larger trial.",[71,28,29,72,73,74,75,76],"Breast Cancer","Hereditary Breast Carcinoma","Breast Neoplasms","DCIS","Germline Mutation Abnormality","Early Breast Cancer",[78,79,80,81,82,83],"breast cancer","mastectomy","endoscopic","robotic","handx","nipple-sparing mastectomy","RECRUITING","2025-12-05",{"date":87,"type":50},"2025-12-18",{"date":89,"type":50},"2025-09-09",{"date":91,"type":21},"2029-10",{"name":93,"class":57},"Vasileios Kalles",1]