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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

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ClinicalTrials.gov Identifier: NCT00972751
Recruitment Status : Completed
First Posted : September 7, 2009
Last Update Posted : September 30, 2015
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Southwest Oncology Group

Tracking Information
First Submitted Date September 4, 2009
First Posted Date September 7, 2009
Last Update Posted Date September 30, 2015
Study Start Date February 2009
Actual Primary Completion Date September 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 6, 2012)
  • 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 ]
Original Primary Outcome Measures
 (submitted: September 4, 2009)
  • Expression of thioredoxin-1 (Trx-1), thioredoxin-interacting protein (TXNIP), and hypoxia inducible factor-1 alpha (HIF-1α)
  • Correlation of expression of these proteins with tumor stage, disease-free survival, overall survival, and risk of recurrence
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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
Official Title Investigation of Thioredoxin-1 Family Protein Expression in Rectal Cancer
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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients enrolled on SWOG-9304, adenocarcinoma of the recturm Stage II or III
Condition Colorectal Cancer
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: September 4, 2009)
220
Original Estimated Enrollment Same as current
Actual Study Completion Date September 2010
Actual Primary Completion Date September 2010   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 120 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT00972751
Other Study ID Numbers CDR0000601255
U10CA032102 ( U.S. NIH Grant/Contract )
SWOG-9304A-ICSC ( Other Identifier: SWOG )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Southwest Oncology Group
Study Sponsor Southwest Oncology Group
Collaborators National Cancer Institute (NCI)
Investigators
Study Chair: Tomislav Dragovich, MD, PhD University of Arizona
PRS Account Southwest Oncology Group
Verification Date September 2015