Ignite Creation Date:
2025-12-25 @ 2:43 AM
Ignite Modification Date:
2025-12-26 @ 1:23 AM
Study NCT ID:
NCT04651933
Status:
UNKNOWN
Last Update Posted:
2020-12-04
First Post:
2020-11-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Training Set for the HRD Model in EOC
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000077216', 'term': 'Carcinoma, Ovarian Epithelial'}], 'ancestors': [{'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010051', 'term': 'Ovarian Neoplasms'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'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'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': "Samples from the patients' peripheral blood and tumor tissues."}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-11-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-12', 'completionDateStruct': {'date': '2022-11-26', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-12-02', 'studyFirstSubmitDate': '2020-11-26', 'studyFirstSubmitQcDate': '2020-11-26', 'lastUpdatePostDateStruct': {'date': '2020-12-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-11-26', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Homologous recombination deficiency (HRD) score', 'timeFrame': 'Two years', 'description': 'The HRD score for individual patient is a scale describing her HRD status. The score model is calculated by the analysis for loss of heterozygosity (LOH), and the minimum value is 0, but the maximun value is not available. Higher scores mean more sensitivity to poly-ADP-ribose polymerase inhibitor'}], 'secondaryOutcomes': [{'measure': 'Progression-free survival', 'timeFrame': 'Five years', 'description': 'Progression-free survival in recruited patients'}, {'measure': 'Overall survival', 'timeFrame': 'Five years', 'description': 'Overall survival in recruited patients'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Epithelial Ovarian Cancer', 'BRCA Mutation', 'Loss of Heterozygosity', 'Prognosis', 'Platinum Resistance', 'Homologous Recombination Deficiency']}, 'descriptionModule': {'briefSummary': 'A homologous recombination deficiency (HRD) scoring model based on loss of heterozygosity (LOH) is little explored in epithelial ovarian cancer (EOC) patients. This study would recruit 200 Chinese EOC patients with known BRCA1/2 mutation status and resistance to platinum-based chemotherapy. A LOH-HRD model is to be constructed based on the genetic testing in these patients. The mutated genes, HRD score model and their relationship with the prognosis, would provide a full description of for the Chinese EOC patients, and a potential explanation of platinum-resistance in such population.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with known BRCA1/2 mutation status and resistance to platinum-based chemotherapy', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged 18 years or older\n* Pathological confirmation of epithelial ovarian cancer\n* With available tumor tissues\n* Given consents to participate the study\n\nExclusion Criteria:\n\n• Not meeting all of the inclusion criteria'}, 'identificationModule': {'nctId': 'NCT04651933', 'briefTitle': 'A Training Set for the HRD Model in EOC', 'organization': {'class': 'OTHER', 'fullName': 'Peking Union Medical College Hospital'}, 'officialTitle': 'A Training Set for the Homologous Recombination Deficiency Scoring Model With Loss of Heterozygosity Status in Epithelial Ovarian Cancer', 'orgStudyIdInfo': {'id': 'EOC-LOH'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Epithelial ovarian cancer patients sensitive to platinum based chemotherapy', 'interventionNames': ['Genetic: Homologous recombination deficiency model']}, {'label': 'Epithelial ovarian cancer patients resistant to platinum based chemotherapy', 'interventionNames': ['Genetic: Homologous recombination deficiency model']}], 'interventions': [{'name': 'Homologous recombination deficiency model', 'type': 'GENETIC', 'description': 'A homologous recombination deficiency (HRD) scoring model based on loss of heterozygosity (LOH)', 'armGroupLabels': ['Epithelial ovarian cancer patients resistant to platinum based chemotherapy', 'Epithelial ovarian cancer patients sensitive to platinum based chemotherapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100730', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Lei Li, MD', 'role': 'CONTACT', 'email': 'lileigh@163.com', 'phone': '8613911988831'}], 'facility': 'Lei Li', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Lei Li, M.D.', 'role': 'CONTACT', 'email': 'lileigh@163.com', 'phone': '+8613911988831'}, {'name': 'Ming Wu, M.D.', 'role': 'CONTACT', 'email': 'wuming@pumch.cn', 'phone': '+8613810224549'}], 'overallOfficials': [{'name': 'Lei Li, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Peking Union Medical College Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Lei Li', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Lei Li', 'investigatorAffiliation': 'Peking Union Medical College Hospital'}}}}