Ignite Creation Date:
2025-12-24 @ 6:39 PM
Ignite Modification Date:
2026-01-01 @ 11:42 AM
Study NCT ID:
NCT01267357
Status:
COMPLETED
Last Update Posted:
2010-12-28
First Post:
2010-12-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
P16 Staining as Prognostic Biomarker in Serous Papillary Endometrial Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': "Existing paraffin pathology blocks in hospital's library were used. Remainder of material was returned to the library.\n\nNo identifying features were retained or attached to specimens."}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 62}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-11', 'lastUpdateSubmitDate': '2010-12-26', 'studyFirstSubmitDate': '2010-12-15', 'studyFirstSubmitQcDate': '2010-12-26', 'lastUpdatePostDateStruct': {'date': '2010-12-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-12-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall survival', 'timeFrame': 'last followup (2-10 years)'}], 'secondaryOutcomes': [{'measure': 'progression free survival', 'timeFrame': 'Current follow up (2-10 years)'}, {'measure': 'correlation of P16 stain with histological diagnosis', 'timeFrame': 'at last follow up (2-10 years)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Serous Papillary Endometrial Cancer', 'Endometrioid endometrial cancer', 'biomarkers', 'P16', 'P53', 'Prognosis'], 'conditions': ['Serous Papillary Endometrial Cancer']}, 'descriptionModule': {'briefSummary': 'P16 is a tumor suppressor protein implicated in serous papillary endometrial carcinoma. Evidence from previous trials indicates that it may be used as a diagnostic biomarker distinguishing this disease from endometrioid endometrial cancer. Additional evidence points to its prognostic value.\n\nThe current study will evaluate p16 both as a diagnostic tool for serous papillary endometrial cancer and as a prognostic biomarker.\n\nfollowing anonymization, histology blocks will be microtomed and stained for P16 and P53 proteins.\n\nBlocks from endometrioid endometrial cancer will be used as a control group.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'women diagnosed with endometrial cancer, having undergone surgery and having received chemotherapy in our institution.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* diagnosis of endometrial cancer\n* histology block exists in hospital's library\n\nExclusion Criteria:\n\n* none"}, 'identificationModule': {'nctId': 'NCT01267357', 'briefTitle': 'P16 Staining as Prognostic Biomarker in Serous Papillary Endometrial Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Rambam Health Care Campus'}, 'officialTitle': 'Expression of the P16 Protein in Serous Papillary Endometrial Cancer, and Its Clinical and Prognostic Significance', 'orgStudyIdInfo': {'id': '230CTIL'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Serous papillary endometrial ca patients', 'description': '30 patients diagnosed with SP endometrial ca', 'interventionNames': ['Other: no intervention']}, {'label': 'Endometrioid endometrial ca', 'description': '32 patients diagnosed with Endometrioid endometrial ca', 'interventionNames': ['Other: no intervention']}], 'interventions': [{'name': 'no intervention', 'type': 'OTHER', 'armGroupLabels': ['Endometrioid endometrial ca', 'Serous papillary endometrial ca patients']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Haifa', 'country': 'Israel', 'facility': 'Rambam Medical Center', 'geoPoint': {'lat': 32.81303, 'lon': 34.99928}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rambam Health Care Campus', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Dr. Itamar Netzer', 'oldOrganization': 'Rambam Medical Center'}}}}