Ignite Creation Date:
2025-12-25 @ 12:36 AM
Ignite Modification Date:
2026-01-07 @ 4:06 AM
Study NCT ID:
NCT04190667
Status:
UNKNOWN
Last Update Posted:
2019-12-10
First Post:
2019-12-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Homologous Recombination Deficiency Status in Epithelial Ovarian Cancer
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000076610', 'term': 'Genetic Profile'}], 'ancestors': [{'id': 'D000068617', 'term': 'Genetic Background'}, {'id': 'D055614', 'term': 'Genetic Phenomena'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': "Samples from the patients' peripheral blood and tumor tissues."}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1300}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-12-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-12', 'completionDateStruct': {'date': '2022-12-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-12-06', 'studyFirstSubmitDate': '2019-12-04', 'studyFirstSubmitQcDate': '2019-12-05', 'lastUpdatePostDateStruct': {'date': '2019-12-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-12-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Frequency of targeted genetic mutations', 'timeFrame': 'Two years', 'description': 'Frequency of pathogenic or likely pathogenic mutations in a multi-panel genes'}, {'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 three types of important molecular mechanism: loss of heterozygosity (LOH), telomere allele imbalance (TAI) and large-scale state transitions (LST)'}], 'secondaryOutcomes': [{'measure': 'Progression-free survival', 'timeFrame': 'Two years', 'description': 'Progression-free survival in recruited patients'}, {'measure': 'Overall survival', 'timeFrame': 'Two years', 'description': 'Overall survival in recruited patients'}, {'measure': 'Rate of sensitivity to platinum-based chemotherapy', 'timeFrame': 'Two years', 'description': 'Sensitivity to platinum-based chemotherapy in recruited patients'}, {'measure': 'Rate of sensitivity to poly-(ADP-ribose) polymerase inhibitors', 'timeFrame': 'Two years', 'description': 'Sensitivity to poly-(ADP-ribose) polymerase inhibitors in recruited patients'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Epithelial Ovarian Cancer', 'Chinese', 'Homologous Recombination Deficiency', 'BRCA1 Mutation', 'BRCA2 Mutation', 'Prognosis']}, 'descriptionModule': {'briefSummary': 'The homologous recombination deficiency (HRD) status in Chinese population with epithelial ovarian cancer (EOC) is little known. This study would recruit 1300 Chinese EOC patients. A multi-panel testing of 36 genes would be given for these patients in their peripheral blood and tumor tissues. These 36 genes include: BRCA1, BRCA2, ABRAXAS1(FAM175A）, ATM, ATR, BAP1, BARD1, BRIP1, C11ORF30（EMSY）, CDK12, CHEK1, CHEK2, FANCA, FANCC, FANCD2, FANCI, FANCL, MRE11A, NBN, PALB2, PPP2R2A, PTEN, RAD50, RAD51B, RAD51C, RAD51D, RAD54B, RAD54, MLH1, MSH2, MSH6, PMS2, EPCAM, STK11, TP53, CDH1. The study would select 150 patients with pathogenic or likely pathogenic mutations in BRCA1/2 and 150 patients without these mutations to further explore the HRD status. The HRD model is based on the loss of heterozygosity (LOH), telomere allele imbalance (TAI) and large-scale state transitions (LST). The mutated genes, HRD score model and their relationship with the prognosis, would provide a full description of for the Chinese EOC patients.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Chinese population with confirmed diagnosis of epithelial ovarian cancer', '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': 'NCT04190667', 'briefTitle': 'Homologous Recombination Deficiency Status in Epithelial Ovarian Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Peking Union Medical College Hospital'}, 'officialTitle': 'A Study on the Homologous Recombination Deficiency Status in Chinese Population With Epithelial Ovarian Cancer', 'orgStudyIdInfo': {'id': 'EOC-HRD'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Genomic testing', 'type': 'DIAGNOSTIC_TEST', 'description': 'A multi-panel testing of 36 genes would be given for these patients in their peripheral blood and tumor tissues. These 36 genes include: BRCA1, BRCA2, ABRAXAS1(FAM175A）, ATM, ATR, BAP1, BARD1, BRIP1, C11ORF30（EMSY）, CDK12, CHEK1, CHEK2, FANCA, FANCC, FANCD2, FANCI, FANCL, MRE11A, NBN, PALB2, PPP2R2A, PTEN, RAD50, RAD51B, RAD51C, RAD51D, RAD54B, RAD54, MLH1, MSH2, MSH6, PMS2, EPCAM, STK11, TP53, CDH1. The study would select 150 patients with pathogenic or likely pathogenic mutations in BRCA1/2 and 150 patients without these mutations to further explore the HRD status.'}]}, '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': '008613911988831'}], 'facility': 'Lei Li', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Lei Li', 'role': 'CONTACT', 'email': 'lileigh@163.com', 'phone': '+8613911988831'}, {'name': 'Ming Wu', 'role': 'CONTACT', 'email': 'wuming@pumch.cn', 'phone': '+8613810224549'}], 'overallOfficials': [{'name': 'Lei Li', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Peking Union Medical College Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Lei Li', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Lei Li', 'investigatorAffiliation': 'Peking Union Medical College Hospital'}}}}