Ignite Creation Date:
2025-12-25 @ 5:01 AM
Ignite Modification Date:
2026-03-01 @ 12:26 PM
Study NCT ID:
NCT05069818
Status:
UNKNOWN
Last Update Posted:
2021-10-06
First Post:
2021-09-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Variance of HRD From Paired Ovarian Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010051', 'term': 'Ovarian 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'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': "The formalin fixation and paraffin embedding (FFPE ) samples from the primary and secondary cytoreductive surgery will be obtained after patients' informed consent."}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2021-10', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2022-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-09-25', 'studyFirstSubmitDate': '2021-09-25', 'studyFirstSubmitQcDate': '2021-09-25', 'lastUpdatePostDateStruct': {'date': '2021-10-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-10-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Loss of heterozygosity (LOH) score in the primary and recurrent ovarian cancer', 'timeFrame': 'Through study completion, an average of 1 year]', 'description': 'The LOH score is a scale describing the genomic loss of heterozygosity status in the primary or recurrent tumor of an ovarian cancer patient. The score is determined by analyzing more than 3500 SNPs spaced at 1Mb intervals across the genome on the FoundationOne CDx test and extrapolating an LOH profile, excluding arm and chromosome-wide LOH segments. The score is summarized as the percentage of the genome with LOH regions.'}, {'measure': 'Homologous recombination deficiency (HRD) status', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'The HRD status for primary or recurrent tumor in a patient is considered according to the LOH score and genomic mutation status of BRCA1 and BRCA2 genes in the sample. A sample with LOH≥16%，and/or with genomic mutation in BRCA1 or BRCA2 gene, is defined as HRD positive. Otherwise, a sample with LOH\\<16% and wild type BRCA1/BRCA2 genes is defined as HRD negative.'}], 'secondaryOutcomes': [{'measure': 'Progression-free survival', 'timeFrame': "From the beginning of the patient's onset, an average of 1 year", 'description': 'Progression-free survival in recruited patients'}, {'measure': 'Overall survival', 'timeFrame': "From the beginning of the patient's onset, an average of 3 year", 'description': 'Overall survival in recruited patients'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Ovarian Cancer', 'HRD', 'Platinum-sensitive Ovarian Cancer']}, 'descriptionModule': {'briefSummary': 'Homologous recombination deficiency (HRD) is an important biomarker of poly (ADP-ribose) polymerase inhibitor (PARPi) in patients with high-grade serous ovarian cancer (HGSOC). The stability of HRD in the recurrent HGSOC and its primary pair remains unknown.', 'detailedDescription': 'This study intends to perform HRD testing of ovarian cancer in the recurrent HGSOC and its primary pair, furtherly correlate HRD status and clinical characteristics in the recurited population.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Platinum-sensitive relapsed high-grade serous ovarian cancer patients undergoing secondary cytoreductive surgery', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Subjects join the study voluntarily and sign informed consent;\n2. Female subjects are older than 18 years;\n3. ECOG(Eastern Cooperative Oncology Group) physical status score is 0-2;\n4. Life expectancy≥3 months;\n5. Histologically confirmed FIGO(International Federation of Gynecology and Obstetrics ) III/IV ovarian cancer, fallopian tube cancer, or primary peritoneal cancer; Participants must have high-grade serous histology\n\nExclusion Criteria:\n\n1. Personnel involved in the formulation or implementation of the research plan;\n2. The subjects had other malignant diseases in past 2 years, except skin squamous cell carcinoma, basal-like carcinoma, breast intraductal carcinoma in situ, or cervical carcinoma in situ;'}, 'identificationModule': {'nctId': 'NCT05069818', 'acronym': 'HOPEII', 'briefTitle': 'Variance of HRD From Paired Ovarian Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Jiangsu Cancer Institute & Hospital'}, 'officialTitle': 'Variance of HRD From Primary to Recurrent in High-grade Serous Ovarian Cancer', 'orgStudyIdInfo': {'id': 'JiangsuCIH011'}}, 'contactsLocationsModule': {'locations': [{'zip': '210009', 'city': 'Nanjing', 'state': 'Jiangsu', 'country': 'China', 'contacts': [{'name': 'Jing Ni, MD', 'role': 'CONTACT', 'email': 'nijingwulin@126.com', 'phone': '+8613813833586'}, {'name': 'Xiaoxiang Chen', 'role': 'CONTACT'}], 'facility': 'Xiaoxiang Chen', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}], 'centralContacts': [{'name': 'Jing Ni, MD', 'role': 'CONTACT', 'email': 'nijingwulin@126.com', 'phone': '+86 13327833586'}, {'name': 'Xiaoxiang Chen, MD,PhD', 'role': 'CONTACT'}], 'overallOfficials': [{'name': 'Xiaoxiang Chen Chen, MD,PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Jiangsu Cancer Institute & Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Xiaoxiang Chen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Academic secretary of gynecological oncology Committee of Jiangsu anti cancer association', 'investigatorFullName': 'Xiaoxiang Chen', 'investigatorAffiliation': 'Jiangsu Cancer Institute & Hospital'}}}}