S9304A Study of Protein Expression in Tumor Tissue Sample... | NCT00972751

Studies
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

NCT00972751

Sponsor

SWOG Cancer Research Network

Status

Completed

Last Update Posted

Sep 30, 2015Estimated

Enrollment

220Actual

Phase

Not provided

Conditions

Colorectal Cancer

Interventions

Not provided

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
U10CA032102	U.S. NIH Grant/Contract		View source
SWOG-9304A-ICSC	Other Identifier	SWOG

Status Module

Record Verification Date

Sep 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2009

Primary Completion Date

Sep 2010Actual

Completion Date

Sep 2010Actual

First Submitted Date

Sep 4, 2009

First Submission Date that Met QC Criteria

Sep 4, 2009

First Posted Date

Sep 7, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 28, 2015

Last Update Posted Date

Sep 30, 2015Estimated

Name	Class
National Cancer Institute (NCI)	NIH

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

220Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Expression of thioredoxin-1, thioredoxin-interacting protein, and hypoxia inducible factor-1 alpha		upon testing of specimens
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

120 Years

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Name	Affiliation	Role
Tomislav Dragovich, MD, PhD	University of Arizona	Study Chair

Condition Browse Module

MeSH Terms

ID	Term
D015179	Colorectal Neoplasms
D012004	Rectal Neoplasms

Ancestor Terms

ID	Term
D007414	Intestinal Neoplasms
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site

Browse Leaves

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Browse Branches

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