Ignite Creation Date:
2025-12-24 @ 11:24 PM
Ignite Modification Date:
2026-02-20 @ 5:56 PM
Study NCT ID:
NCT03742856
Status:
UNKNOWN
Last Update Posted:
2018-11-15
First Post:
2018-11-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Multi-omics Study of Epithelial Ovarian Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000077216', 'term': 'Carcinoma, Ovarian Epithelial'}, {'id': 'D063646', 'term': 'Carcinogenesis'}], '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'}, {'id': 'D009385', 'term': 'Neoplastic Processes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'An 8 ml peripheral venous blood, and 50 μL cancer tissue and tissue adjacent to cancer will be collected from eligible patients.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-11-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-11', 'completionDateStruct': {'date': '2020-11-23', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-11-13', 'studyFirstSubmitDate': '2018-11-09', 'studyFirstSubmitQcDate': '2018-11-13', 'lastUpdatePostDateStruct': {'date': '2018-11-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-11-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-11-23', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Frequencies of somatic driving mutations', 'timeFrame': 'Two years', 'description': 'The differences of frequencies of somatic driving mutations will be compared between patients of different FIGO stages and different pathological subtypes.'}], 'secondaryOutcomes': [{'measure': 'Frequencies of alteration of RNA expression', 'timeFrame': 'Two years', 'description': 'The alteration of RNA expression, including mRNA, miRNA, and lncRNA, will be compared between patients of different FIGO stages and different pathological subtypes.'}, {'measure': 'Frequencies of alteration of protein expression and signal pathway', 'timeFrame': 'Two years', 'description': 'The alteration of patterns of protein expression and signal pathway will be compared between patients of different FIGO stages and different pathological subtypes.'}, {'measure': 'Progression-free survival', 'timeFrame': 'Five years', 'description': 'Progression-free survival between patients with differential expressed multi-omics will be compared.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Epithelial Ovarian Cancer', 'Tumor Invasiveness', 'Whole Exome Sequencing', 'Transcriptomics', 'Metabolomics', 'Tumorigenesis']}, 'descriptionModule': {'briefSummary': 'This study aims to analyze the multi-omics results between epithelial ovarian cancer (EOC) patient with different FIGO stages and pathological subtypes. The multi-omics profiles include whole exome sequencing, analysis of transcriptomics and metabolomics. A comprehensive multi-omics will reveal the invasiveness and tumorigenesis of EOC.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients confirmed primary epithelial ovarian cancer will be included for analysis.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Confirmed primary epithelial ovarian cancer\n* Signed an approved informed consents\n* Feasible for biopsy\n\nExclusion Criteria:\n\n* Not meeting all of the inclusion criteria'}, 'identificationModule': {'nctId': 'NCT03742856', 'briefTitle': 'A Multi-omics Study of Epithelial Ovarian Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Peking Union Medical College Hospital'}, 'officialTitle': 'A Multi-omics Study on the Invasiveness of Epithelial Ovarian Cancer', 'orgStudyIdInfo': {'id': 'EOC-OMICS'}}, 'armsInterventionsModule': {'interventions': [{'name': 'A multi-omics analysis', 'type': 'COMBINATION_PRODUCT', 'description': 'A multi-omics analysis including whole exome sequencing, transcriptomics and metabolomics.'}]}, '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': '13911988831', 'phoneExt': '86'}], 'facility': 'Lei Li', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Lei Li, M.D.', 'role': 'CONTACT', 'email': 'lileigh@163.com', 'phone': '13911988831', 'phoneExt': '86'}], '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'}}}}