Ignite Creation Date:
2025-12-24 @ 11:40 PM
Ignite Modification Date:
2025-12-28 @ 12:45 PM
Study NCT ID:
NCT00972751
Status:
COMPLETED
Last Update Posted:
2015-09-30
First Post:
2009-09-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
S9304A Study of Protein Expression in Tumor Tissue Samples From Patients With Stage II or Stage III Rectal Cancer Enrolled in Clinical Trial SWOG-9304
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D012004', 'term': 'Rectal Neoplasms'}], 'ancestors': [{'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 220}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-09', 'completionDateStruct': {'date': '2010-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-09-28', 'studyFirstSubmitDate': '2009-09-04', 'studyFirstSubmitQcDate': '2009-09-04', 'lastUpdatePostDateStruct': {'date': '2015-09-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-09-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Expression of thioredoxin-1, thioredoxin-interacting protein, and hypoxia inducible factor-1 alpha', 'timeFrame': 'upon testing of specimens'}, {'measure': 'Correlation of expression of these proteins with tumor stage, disease-free survival, overall survival, and risk of recurrence', 'timeFrame': 'upon provision of expression to Statistical Center'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['stage II rectal cancer', 'stage III rectal cancer', 'adenocarcinoma of the rectum'], 'conditions': ['Colorectal Cancer']}, 'descriptionModule': {'briefSummary': 'RATIONALE: Studying samples of tumor 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. It may also help doctors predict how patients will respond to treatment.\n\nPURPOSE: This research study is looking at protein expression in tumor tissue samples from patients with stage II or stage III rectal cancer enrolled in clinical trial SWOG-9304.', 'detailedDescription': 'OBJECTIVES:\n\n* Determine expression levels of thioredoxin-1 (Trx-1), thioredoxin-interacting protein (TXNIP), and hypoxia inducible factor-1 alpha (HIF-1α) in paraffin-embedded resected tumor tissue samples from patients with stage II or III rectal cancer enrolled in clinical trial SWOG-9304.\n* Determine if there is a correlation between Trx-1 and TXNIP expression and HIF-1α expression.\n* Correlate expression of these proteins with tumor stage, disease-free survival, overall survival, and risk of recurrence.\n* Determine interactions for patient age, performance status, and type of therapy received on clinical trial SWOG-9304.\n\nOUTLINE: This is a multicenter study.\n\nParaffin-embedded resected tumor tissue samples are analyzed for protein expression levels (thioredoxin-1, thioredoxin-interacting protein, and hypoxia inducible factor-1 alpha) by tissue microarray and immunostaining.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '120 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients enrolled on SWOG-9304, adenocarcinoma of the recturm Stage II or III', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Histologically confirmed adenocarcinoma of the rectum\n\n * Stage II or III disease\n * No metastases\n* Enrolled on clinical trial SWOG-9304\n\nPATIENT CHARACTERISTICS:\n\n* Not specified\n\nPRIOR CONCURRENT THERAPY:\n\n* See Disease Characteristics'}, 'identificationModule': {'nctId': 'NCT00972751', 'briefTitle': 'S9304A Study of Protein Expression in Tumor Tissue Samples From Patients With Stage II or Stage III Rectal Cancer Enrolled in Clinical Trial SWOG-9304', 'organization': {'class': 'NETWORK', 'fullName': 'SWOG Cancer Research Network'}, 'officialTitle': 'Investigation of Thioredoxin-1 Family Protein Expression in Rectal Cancer', 'orgStudyIdInfo': {'id': 'CDR0000601255'}, 'secondaryIdInfos': [{'id': 'U10CA032102', 'link': 'https://reporter.nih.gov/quickSearch/U10CA032102', 'type': 'NIH'}, {'id': 'SWOG-9304A-ICSC', 'type': 'OTHER', 'domain': 'SWOG'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Tomislav Dragovich, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Arizona'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'SWOG Cancer Research Network', 'class': 'NETWORK'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}