NCT00972751

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
220

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2009

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2009

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

September 4, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 7, 2009

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2010

Completed
Last Updated

September 30, 2015

Status Verified

September 1, 2015

Enrollment Period

1.6 years

First QC Date

September 4, 2009

Last Update Submit

September 28, 2015

Conditions

Colorectal Cancer

Keywords

stage II rectal cancerstage III rectal canceradenocarcinoma of the rectum

Outcome Measures

Primary Outcomes (2)

  • 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

Eligibility Criteria

Age18 Years - 120 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

MeSH Terms

Conditions

Colorectal NeoplasmsRectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • Tomislav Dragovich, MD, PhD

    University of Arizona

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 4, 2009

First Posted

September 7, 2009

Study Start

February 1, 2009

Primary Completion

September 1, 2010

Study Completion

September 1, 2010

Last Updated

September 30, 2015

Record last verified: 2015-09