Ignite Creation Date:
2025-12-25 @ 1:14 AM
Ignite Modification Date:
2025-12-25 @ 11:24 PM
Study NCT ID:
NCT06972693
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-05-15
First Post:
2025-01-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
NGS-based Germline and Somatic Genetic Test in Ovarian Carcinoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010051', 'term': 'Ovarian Neoplasms'}, {'id': 'D005185', 'term': 'Fallopian Tube Neoplasms'}], 'ancestors': [{'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010049', 'term': 'Ovarian Diseases'}, {'id': 'D000291', 'term': 'Adnexal Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}, {'id': 'D005184', 'term': 'Fallopian Tube Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'prospective observational study'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 323}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2018-06-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2025-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-14', 'studyFirstSubmitDate': '2025-01-07', 'studyFirstSubmitQcDate': '2025-05-14', 'lastUpdatePostDateStruct': {'date': '2025-05-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-05-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Prevalence of clinically relevant mutations in ovarian cancer riskassociated genes', 'timeFrame': '3 months', 'description': 'evaluate prevalence of clinically relevant mutations in ovarian cancer risk associated genes'}, {'measure': 'Percentage of informative specimens', 'timeFrame': '3 months', 'description': 'Percentage of informative specimens'}, {'measure': 'Genetic test turnaround time', 'timeFrame': '3 months', 'description': 'Evaluate Genetic test turnaround time'}], 'secondaryOutcomes': [{'measure': 'Incidence of all other mutations', 'timeFrame': '3 months', 'description': 'Incidence of all other mutations'}, {'measure': 'progression-free survival', 'timeFrame': '10 years', 'description': 'progression-free survival'}, {'measure': 'overall survival', 'timeFrame': '10 years', 'description': 'overall survival'}, {'measure': 'Comparison of mutational profile across platforms: Devyser vs GerSom for BRC1/BRCA2', 'timeFrame': '3 months', 'description': 'Comparison of mutation in BRC1/BRCA2 genes between Devyser vs GerSom platform'}, {'measure': 'Comparison of mutational profile across platforms: Trusight vs GerSom for all variants covered by both panels', 'timeFrame': '3 months', 'description': 'Comparison of all gene mutations between Trusight and GerSom platform'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Ovarian Carcinoma', 'Fallopian Tube Carcinoma', 'Primary Peritoneal Carcinoma']}, 'descriptionModule': {'briefSummary': 'For patients with ovarian cancer and biologically related diseases, the implementation of genetic testing in the decision-making process could have an impact both on the risk management for the patient and his/her family, but also, more importantly, on the therapeutic management.\n\nThe identification of genetically predisposed subjects can suggest risk reduction strategies that may involve bilateral salpingo-oophorectomy, mastectomy or long-term medical approaches. In the advanced setting, genetic testing may influence the decision for medical therapy (e.g. use of platinum derivatives or PARP inhibitors in patients with "BRCAness+" ovarian cancer).\n\nThe selection of patients for genetic testing has so far been restricted to patients with a strong family history of breast and ovarian cancer. It is now clear that the strict application of this criterion will result in a substantial number of people with a missed BRCA mutation.\n\nSystematic large-scale genetic testing, simultaneously on germline and somatic tissues, is likely to improve decision-making algorithms in ovarian cancer patients. The feasibility of such an approach in the clinical setting, in terms of response times compatible with clinical needs and sensitivity comparable if not superior to single-gene tests, needs to be demonstrated before such diagnostic platforms can be routinely implemented in the diagnostic workflow.\n\nThis is the aim of the present study.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. age 18 or higher\n2. has signed informed consent\n3. histologically confirmed ovarian cancer, Fallopian tube cancer, or primary peritoneal cancer.\n4. Any stage is admitted\n5. Any histology is admitted\n6. availability of surgical/bioptic material. Formalin-fixed, paraffinembedded or frozen specimens are both allowed, with no time limitation\n\nExclusion Criteria:\n\n1\\. unable or unwilling to receive genetic counseling'}, 'identificationModule': {'nctId': 'NCT06972693', 'acronym': 'PERSONA-Ovary', 'briefTitle': 'NGS-based Germline and Somatic Genetic Test in Ovarian Carcinoma', 'organization': {'class': 'OTHER', 'fullName': 'European Institute of Oncology'}, 'officialTitle': 'Evaluating the Feasibility of NGS-based Germline and Somatic Genetic Testing in Ovarian Carcinoma. The PERSONA-ovary Trial', 'orgStudyIdInfo': {'id': 'IEO 791'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'BRCA testing', 'interventionNames': ['Genetic: BRCA testing']}], 'interventions': [{'name': 'BRCA testing', 'type': 'GENETIC', 'description': 'BRCA 1 and 2 testing', 'armGroupLabels': ['BRCA testing']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20141', 'city': 'Milan', 'state': 'Italy', 'country': 'Italy', 'facility': 'Istituto Europeo di Oncologia', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'European Institute of Oncology', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}