Ignite Creation Date:
2025-12-24 @ 11:49 PM
Ignite Modification Date:
2026-02-01 @ 11:18 PM
Study NCT ID:
NCT03155451
Status:
COMPLETED
Last Update Posted:
2017-10-19
First Post:
2017-05-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Plasma ctDNA Detection in Diagnosis of 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'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'blood samples'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 43}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-08-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-10', 'completionDateStruct': {'date': '2017-10-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-10-18', 'studyFirstSubmitDate': '2017-05-13', 'studyFirstSubmitQcDate': '2017-05-13', 'lastUpdatePostDateStruct': {'date': '2017-10-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-05-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-10-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pathological diagnosis of ovarian lumps', 'timeFrame': 'One week after surgery', 'description': 'Pathological diagnosis of ovarian lumps，including immunohistochemical information and HE staining information.'}], 'secondaryOutcomes': [{'measure': 'sensitivity (true positive rate)', 'timeFrame': '2 year', 'description': 'The proportion of persons with disease who have a positive test (positive test results among persons with disease)'}, {'measure': 'Specificity (true negative rate)', 'timeFrame': '2 year', 'description': 'The proportion of persons without disease who have a negative test (negative test results among persons without disease)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Epithelial Ovarian Cancer']}, 'referencesModule': {'references': [{'pmid': '26516143', 'type': 'BACKGROUND', 'citation': 'Wen L, Li J, Guo H, Liu X, Zheng S, Zhang D, Zhu W, Qu J, Guo L, Du D, Jin X, Zhang Y, Gao Y, Shen J, Ge H, Tang F, Huang Y, Peng J. Genome-scale detection of hypermethylated CpG islands in circulating cell-free DNA of hepatocellular carcinoma patients. Cell Res. 2015 Nov;25(11):1250-64. doi: 10.1038/cr.2015.126. Epub 2015 Oct 30.'}, {'pmid': '25707631', 'type': 'BACKGROUND', 'citation': 'Nick AM, Coleman RL, Ramirez PT, Sood AK. A framework for a personalized surgical approach to ovarian cancer. Nat Rev Clin Oncol. 2015 Apr;12(4):239-45. doi: 10.1038/nrclinonc.2015.26. Epub 2015 Feb 24.'}]}, 'descriptionModule': {'briefSummary': 'Epithelial ovarian cancer constitutes one of the most common gynecological malignancies.Because the ovaries lie in the deep pelvic cavity,most ovarian cancer patients are asymptomatic, rendering the majority often diagnosed at an advanced stage.ctDNA in cancer patients often bears similar genetic and epigenetic features to the related tumor DNA.This study aims to detect plasma ctDNA in Diagnosis of Epithelial Ovarian Cancer.', 'detailedDescription': "Epithelial ovarian cancer constitutes one of the most common gynecological malignancies, with an incidence rate of 3-12/100 000 woman per year. Because the ovaries lie in the deep pelvic cavity,most ovarian cancer patients are asymptomatic, rendering the majority often diagnosed at an advanced stage. Liquid biopsy, which is meant to detect cancers by sequencing the DNA in a few drops of a person's blood. It may detect cancers early, even before symptoms arise, when there is just a few cells in the blood circulation.\n\nctDNA in cancer patients often bears similar genetic and epigenetic features to the related tumor DNA. There is evidence that some of the ctDNA originates from tumor tissue. This, and the fact that ctDNA can easily be isolated from the circulation and other body fluids of patients, makes it a promising candidate as a non-invasive biomarker of cancer.\n\nThis study aims to detect plasma ctDNA in Diagnosis of Epithelial Ovarian Cancer."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'consecutive colletion of patinets with ovarian cancer treatment at our clinical centre', 'genderDescription': 'Adult women', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* people aged 18years to 80years;\n* Diagnosis of ovarian cancer is confirmed by two Pathologists independently;\n* Pregnancy tests are negative.\n\nExclusion Criteria:\n\n* With other type of malignancies;\n* someone who refuse to participate the study.'}, 'identificationModule': {'nctId': 'NCT03155451', 'acronym': 'ctDNA_EOC', 'briefTitle': 'Plasma ctDNA Detection in Diagnosis of Epithelial Ovarian Cancer.', 'organization': {'class': 'OTHER', 'fullName': 'RenJi Hospital'}, 'officialTitle': 'Plasma ctDNA Detection in Diagnosis of Epithelial Ovarian Cancer.', 'orgStudyIdInfo': {'id': '[2017]012'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Epithelial ovarian cancer', 'description': 'patients receive the ctDNA methylation markers screening', 'interventionNames': ['Diagnostic Test: methylation markers screening']}], 'interventions': [{'name': 'methylation markers screening', 'type': 'DIAGNOSTIC_TEST', 'description': 'ctDNA extraction from plasma samples;bisulfite-treated DNA;DNA methylation levels by deep sequencing-Sequencing; data analysis', 'armGroupLabels': ['Epithelial ovarian cancer']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200126', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Renji Hospital, School of Medicine, Shanghai Jiao Tong University', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'overallOfficials': [{'name': 'Yu Wang, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'RenJi Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'M.D.', 'investigatorFullName': 'Wang Yu', 'investigatorAffiliation': 'RenJi Hospital'}}}}