Ignite Creation Date:
2025-12-24 @ 11:40 PM
Ignite Modification Date:
2025-12-28 @ 12:45 PM
Study NCT ID:
NCT00972751
Status:
COMPLETED
Last Update Posted:
2015-09-30
First Post:
2009-09-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
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
Sponsor:
SWOG Cancer Research Network
Organization:
Study Overview
Official Title:
Investigation of Thioredoxin-1 Family Protein Expression in Rectal Cancer
Status:
COMPLETED
Status Verified Date:
2015-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
* 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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| U10CA032102 | NIH | None | https://reporter.nih.gov/quic… | View |
| SWOG-9304A-ICSC | OTHER | SWOG | View |