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

NCT ID: NCT00972751

Last Updated: 2015-09-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

220 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-02-28

Study Completion Date

2010-09-30

Brief Summary

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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

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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.

Conditions

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Colorectal Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

120 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

SWOG Cancer Research Network

NETWORK

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Tomislav Dragovich, MD, PhD

Role: STUDY_CHAIR

University of Arizona

Other Identifiers

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U10CA032102

Identifier Type: NIH

Identifier Source: secondary_id

View Link

SWOG-9304A-ICSC

Identifier Type: OTHER

Identifier Source: secondary_id

CDR0000601255

Identifier Type: -

Identifier Source: org_study_id

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