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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Southwest Oncology Group
ClinicalTrials.gov Identifier:
NCT00972751
First received: September 4, 2009
Last updated: March 6, 2012
Last verified: March 2012

September 4, 2009
March 6, 2012
February 2009
September 2010   (final data collection date for primary outcome measure)
  • Expression of thioredoxin-1, thioredoxin-interacting protein, and hypoxia inducible factor-1 alpha [ Time Frame: upon testing of specimens ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Expression of thioredoxin-1 (Trx-1), thioredoxin-interacting protein (TXNIP), and hypoxia inducible factor-1 alpha (HIF-1α) [ Designated as safety issue: No ]
  • Correlation of expression of these proteins with tumor stage, disease-free survival, overall survival, and risk of recurrence [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00972751 on ClinicalTrials.gov Archive Site
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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

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Retrospective
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Non-Probability Sample

Patients enrolled on SWOG-9304, adenocarcinoma of the recturm Stage II or III

Colorectal Cancer
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
220
September 2010
September 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00972751
CDR0000601255, U10CA032102, SWOG-9304A-ICSC
No
Southwest Oncology Group
Southwest Oncology Group
National Cancer Institute (NCI)
Study Chair: Tomislav Dragovich, MD, PhD University of Arizona
Southwest Oncology Group
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP