Ignite Creation Date:
2025-12-24 @ 10:19 PM
Ignite Modification Date:
2025-12-27 @ 11:51 AM
Study NCT ID:
NCT00053235
Status:
WITHDRAWN
Last Update Posted:
2015-06-01
First Post:
2003-01-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Research Study in Patients With Advanced Ovarian Epithelial 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D055028', 'term': 'Comparative Genomic Hybridization'}, {'id': 'D016133', 'term': 'Polymerase Chain Reaction'}], 'ancestors': [{'id': 'D020732', 'term': 'Cytogenetic Analysis'}, {'id': 'D005821', 'term': 'Genetic Techniques'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D025202', 'term': 'Molecular Diagnostic Techniques'}, {'id': 'D009693', 'term': 'Nucleic Acid Hybridization'}, {'id': 'D021141', 'term': 'Nucleic Acid Amplification Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2002-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-05', 'lastUpdateSubmitDate': '2015-05-29', 'studyFirstSubmitDate': '2003-01-27', 'studyFirstSubmitQcDate': '2003-01-27', 'lastUpdatePostDateStruct': {'date': '2015-06-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2003-01-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Association between above chromosomal changes and clinical characteristics', 'timeFrame': 'baseline'}, {'measure': 'Determination of whether a gain in chromosome 8q is predictive of worse overall survival in these patients', 'timeFrame': 'baseline'}, {'measure': 'Determination of whether other previously identified chromosomal changes (3q gain, 7q gain, 16q loss, and 17pter-q21 loss) predict outcome', 'timeFrame': 'baseline'}, {'measure': 'Identification of up to 5 additional chromosomal changes and their association that may predict outcome (progression-free and overall survival)', 'timeFrame': 'baseline'}, {'measure': 'Validation of the observation that a gain in chromosome 8q is predictive of shorter progression-free survival in patients with primary grade 2 or grade 3 advanced serous papillary ovarian cancer by PCR and Taqman analyses', 'timeFrame': 'baseline'}]}, 'conditionsModule': {'conditions': ['Ovarian Serous Cystadenocarcinoma', 'Ovarian Serous Surface Papillary Adenocarcinoma', 'Stage IIIA Ovarian Cancer', 'Stage IIIB Ovarian Cancer', 'Stage IIIC Ovarian Cancer', 'Stage IV Ovarian Cancer']}, 'descriptionModule': {'briefSummary': 'This research trial studies tissue samples from patients with ovarian cancer in the laboratory. Analyzing tissue samples from patients in the laboratory may help doctors learn more about cancer.', 'detailedDescription': 'OBJECTIVES:\n\nI. Utilize array comparative genomic hybridization and Taqman analyses, a quantitative genomic polymerase chain reaction, to validate the observation that a gain in chromosome 8q is predictive of shorter progression-free survival in patients with primary grade 2 or grade 3 advanced serous papillary ovarian cancer.\n\nII. Utilize these analyses to determine whether a gain in chromosome 8q is predictive of worse overall survival in these patients.\n\nIII. Utilize these analyses to determine whether other previously identified chromosomal changes (3q gain, 7q gain, 16q loss, and 17pter-q21 loss) predict outcome in these patients and the association between these changes and clinical characteristics.\n\nIV. Utilize these analyses to identify up to 5 additional chromosomal changes and their association that may predict outcome (progression-free and overall survival) in these patients.\n\nOUTLINE:\n\nGenomic DNA is isolated from optimal cutting temperature (OCT)-embedded tissue and analyzed using comparative genomic hybridization. The chromosomal changes identified by this method are compared to those identified using the Taqman method, a quantitative genomic polymerase chain reaction analysis. Chromosome 8q is of specific interest. Other chromosomal changes may be detected in chromosomes 3q, 7q, 16q, and/or 17pter-q21.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Stage III or IV, high-grade (grade 2 or 3) ovarian cancers\n\n * No borderline or low-grade (grade 1) tumors\n * Tissue from predominately serous ovarian cancer only\n\n * No clear cell, endometrioid, mucinous, transitional cell, or mixed without predominant serous component\n* Tissue obtained during prior optimal or suboptimal cytoreductive surgery\n* Must be enrolled on GOG-0136 and a GOG front-line paclitaxel/platinum chemotherapy trial\n* Frozen tissue and hematoxylin-eosin stained section from the ovary obtained at initial surgery\n* Performance status - GOG 0-2'}, 'identificationModule': {'nctId': 'NCT00053235', 'briefTitle': 'Research Study in Patients With Advanced Ovarian Epithelial Cancer', 'organization': {'class': 'NETWORK', 'fullName': 'GOG Foundation'}, 'officialTitle': 'A Pilot Study to Correlate DNA Sequence Copy Number Abnormalities With Outcome in Patients With Advanced Epithelial Ovarian Cancer', 'orgStudyIdInfo': {'id': 'GOG-8004'}, 'secondaryIdInfos': [{'id': 'NCI-2009-00612', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}, {'id': 'CDR0000269315'}, {'id': 'GOG-8004', 'type': 'OTHER', 'domain': 'Gynecologic Oncology Group'}, {'id': 'GOG-8004', 'type': 'OTHER', 'domain': 'CTEP'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Ancillary-Correlative', 'description': 'Genomic DNA is isolated from OCT-embedded tissue and analyzed using comparative genomic hybridization. The chromosomal changes identified by this method are compared to those identified using the Taqman method, a quantitative genomic polymerase chain reaction analysis. Chromosome 8q is of specific interest. Other chromosomal changes may be detected in chromosomes 3q, 7q, 16q, and/or 17pter-q21.', 'interventionNames': ['Genetic: Comparative Genomic Hybridization', 'Other: Laboratory Biomarker Analysis', 'Genetic: Polymerase Chain Reaction']}], 'interventions': [{'name': 'Comparative Genomic Hybridization', 'type': 'GENETIC', 'otherNames': ['CGH', 'Comparative Genome Hybridization', 'Comparative Genomic Analysis'], 'description': 'Correlative studies', 'armGroupLabels': ['Ancillary-Correlative']}, {'name': 'Laboratory Biomarker Analysis', 'type': 'OTHER', 'description': 'Correlative studies', 'armGroupLabels': ['Ancillary-Correlative']}, {'name': 'Polymerase Chain Reaction', 'type': 'GENETIC', 'otherNames': ['PCR'], 'description': 'Correlative studies', 'armGroupLabels': ['Ancillary-Correlative']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19103', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Gynecologic Oncology Group', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'overallOfficials': [{'name': 'David Gershenson', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Gynecologic Oncology Group'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gynecologic Oncology Group', 'class': 'NETWORK'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}