Ignite Creation Date:
2025-12-25 @ 12:31 AM
Ignite Modification Date:
2025-12-25 @ 10:37 PM
Study NCT ID:
NCT01208467
Status:
COMPLETED
Last Update Posted:
2017-08-23
First Post:
2010-09-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Prognostic Biomarkers in Patients With Endometrial Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2824}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-08', 'lastUpdateSubmitDate': '2017-08-22', 'studyFirstSubmitDate': '2010-09-23', 'studyFirstSubmitQcDate': '2010-09-23', 'lastUpdatePostDateStruct': {'date': '2017-08-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-09-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'ATR mutation status', 'timeFrame': '1 month', 'description': 'Parametric and non-parametric statistical tests will be performed to evaluate the association between ATR mutation status and demographic and clinical data. Product-limit estimates according to Kaplan-Meier method will be calculated and difference between survival according to ATR mutation status will be assessed using a two sided log rank test. The predictive ability of the final model will be assessed using a concordance index (C-statistic).'}, {'measure': 'Microsatellite instability (MSI)', 'timeFrame': '1 month'}]}, 'conditionsModule': {'conditions': ['Endometrial Adenocarcinoma', 'Recurrent Uterine Corpus Carcinoma', 'Stage I Uterine Corpus Cancer', 'Stage II Uterine Corpus Cancer', 'Stage III Uterine Corpus Cancer', 'Stage IV Uterine Corpus Cancer']}, 'descriptionModule': {'briefSummary': 'This research study is studying prognostic biomarkers in tissue samples from patients with endometrial cancer. Studying samples of tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.', 'detailedDescription': 'PRIMARY OBJECTIVES:\n\nI. To validate the clinicopathologic associations and prognostic significance of ATR mutation in endometrioid endometrial cancer cases with defective DNA mismatch repair.\n\nOUTLINE: This is a multicenter study.\n\nDNA extracted from previously collected tumor samples is analyzed to validate the clinicopathologic associations and prognostic significance of ATR mutation.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with endometrial cancer', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women who were eligible and evaluable for the GOG-0210 molecular staging protocol in women with endometrial cancer\n\n * Women who were registered during the unrestricted enrollment period (through 9/23/07) will automatically qualify\n * Women who were registered during the restricted enrollment period (after 9/23/07) will only be considered if needed\n* Women who had histologically confirmed endometrioid endometrial adenocarcinoma regardless of stage or grade\n* Women who have defective DNA mismatch repair and are microsatellite instability positive (MSI+ and MSI-low)\n* Women who consented to allow their specimens and clinical data to be used for future cancer research\n* Women who have sufficient high-quality genomic DNA from tumor available for mutation analysis of ATR'}, 'identificationModule': {'nctId': 'NCT01208467', 'briefTitle': 'Prognostic Biomarkers in Patients With Endometrial Cancer', 'organization': {'class': 'NETWORK', 'fullName': 'GOG Foundation'}, 'officialTitle': 'Validating The Prognostic Role of ATR Mutation in Patients With Endometrioid Endometrial Cancer', 'orgStudyIdInfo': {'id': 'GOG-8017'}, 'secondaryIdInfos': [{'id': 'NCI-2011-02870', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}, {'id': 'GOG-8017'}, {'id': 'CDR0000685834'}, {'id': 'GOG-8017', 'type': 'OTHER', 'domain': 'Gynecologic Oncology Group'}, {'id': 'GOG-8017', 'type': 'OTHER', 'domain': 'CTEP'}, {'id': 'U10CA027469', 'link': 'https://reporter.nih.gov/quickSearch/U10CA027469', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Basic science (DNA analysis)', 'description': 'DNA extracted from previously collected tumor samples is analyzed to validate the clinicopathologic associations and prognostic significance of ATR mutation.', 'interventionNames': ['Other: Laboratory Biomarker Analysis']}], 'interventions': [{'name': 'Laboratory Biomarker Analysis', 'type': 'OTHER', 'description': 'Correlative studies', 'armGroupLabels': ['Basic science (DNA analysis)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19103', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Gynecologic Oncology Group', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'overallOfficials': [{'name': 'Israel Zighelboim', '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'}}}}