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

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.

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Key information

Conditions

Colorectal Cancer Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases Rectal Neoplasms

Age range

18 year–120 year

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

Expression of thioredoxin-1, thioredoxin-interacting protein, and hypoxia inducible factor-1 alpha

Time frame: upon testing of specimens
Correlation of expression of these proteins with tumor stage, disease-free survival, overall survival, and risk of recurrence

Time frame: upon provision of expression to Statistical Center

Sponsors and collaborators

Lead sponsor

SWOG Cancer Research Network

Network

Collaborators

National Cancer Institute (NCI)

Registry information

Official study title

Investigation of Thioredoxin-1 Family Protein Expression in Rectal Cancer

Important dates

Study start: 2009
Primary completion: 2010
Study completion: 2010
First posted: Sep 7, 2009
Registry last updated: Sep 30, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed