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

Investigation of Thioredoxin-1 Family Protein Expression in Rectal Cancer

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00972751

Enrollment

220

Registered

2009-09-07

Start date

2009-02-28

Completion date

2010-09-30

Last updated

2015-09-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Cancer

Keywords

stage II rectal cancer, stage III rectal cancer, adenocarcinoma of the rectum

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 120 Years

Healthy volunteers

Inclusion criteria

DISEASE CHARACTERISTICS: * Histologically confirmed adenocarcinoma of the rectum * Stage II or III disease * No metastases * Enrolled on clinical trial SWOG-9304 PATIENT CHARACTERISTICS: * Not specified PRIOR CONCURRENT THERAPY: * See Disease Characteristics

Design outcomes

Primary

Measure	Time frame
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

Outcome results