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

Colorectal Cancer Clinical Trial

Official title:

Investigation of Thioredoxin-1 Family Protein Expression in Rectal Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00972751
• Other study ID #: CDR0000601255
• Secondary ID: U10CA032102SWOG-
• Status: Completed
• Phase: N/A
• First received: September 4, 2009
• Last updated: September 28, 2015
• Start date: February 2009
• Est. completion date: September 2010

Study information

• Verified date: September 2015
• Source: Southwest Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 220
• Est. completion date: September 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 120 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Colorectal Cancer

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Southwest Oncology Group	National Cancer Institute (NCI)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Expression of thioredoxin-1, thioredoxin-interacting protein, and hypoxia inducible factor-1 alpha		upon testing of specimens	No
Primary	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	No