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

Completed

• Conditions: Colorectal Cancer

• Registration Number: NCT00972751
• Lead Sponsor: SWOG Cancer Research Network

Brief Summary

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.

PURPOSE: 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.

Detailed Description

OBJECTIVES:

* 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.

* Determine if there is a correlation between Trx-1 and TXNIP expression and HIF-1α expression.

* Correlate expression of these proteins with tumor stage, disease-free survival, overall survival, and risk of recurrence.

* Determine interactions for patient age, performance status, and type of therapy received on clinical trial SWOG-9304.

OUTLINE: This is a multicenter study.

Paraffin-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.

Study Timeline

• Study Start: 2009-02
• Study First Submitted: 2009-09-04
• Study First Submitted QC: 2009-09-04
• Study First Posted: 2009-09-07
• Primary Completion: 2010-09
• Study Completion: 2010-09
• Status Verified: 2015-09
• Last Update Submitted: 2015-09-28
• Last Update Posted: 2015-09-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 220

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Expression of thioredoxin-1, thioredoxin-interacting protein, and hypoxia inducible factor-1 alpha	upon testing of specimens
Correlation of expression of these proteins with tumor stage, disease-free survival, overall survival, and risk of recurrence	upon provision of expression to Statistical Center