NCT00897819

Brief Summary

RATIONALE: Studying samples of blood, urine, and 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 respond to treatment. PURPOSE: This laboratory study is analyzing the DNA in tissue samples from patients with advanced colorectal cancer treated with fluorouracil and oxaliplatin with or without bevacizumab on clinical trial E-3200.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
350

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2007

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 3, 2007

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2008

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

May 9, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 12, 2009

Completed
Last Updated

May 19, 2017

Status Verified

May 1, 2017

Enrollment Period

1.1 years

First QC Date

May 9, 2009

Last Update Submit

May 17, 2017

Conditions

Colorectal Cancer

Keywords

recurrent colon cancerrecurrent rectal cancerstage III colon cancerstage III rectal cancerstage IV colon cancerstage IV rectal canceradenocarcinoma of the colonadenocarcinoma of the rectum

Outcome Measures

Primary Outcomes (1)

  • Correlation of MSI and LOH to outcome and response

    1 month

Interventions

DNA methylation analysisGENETIC
loss of heterozygosity analysisGENETIC
microsatellite instability analysisGENETIC
laboratory biomarker analysisOTHER

Eligibility Criteria

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

Samples submitted for research from patients participating in E3200

DISEASE CHARACTERISTICS: * Diagnosis of adenocarcinoma of the colon or rectum * Advanced disease * Enrolled on clinical trial E-3200 and received fluorouracil and oxaliplatin * Tumor tissue blocks available * Routine pathology specimens (i.e., blood, urine) available 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 NeoplasmsColonic NeoplasmsRectal Neoplasms

Interventions

DNA Methylation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

MethylationAlkylationBiochemical PhenomenaChemical PhenomenaMetabolismGenetic Phenomena

Study Officials

  • Stanley Hamilton, MD

    M.D. Anderson Cancer Center

    STUDY CHAIR

Study Design

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

Study Record Dates

First Submitted

May 9, 2009

First Posted

May 12, 2009

Study Start

January 3, 2007

Primary Completion

January 30, 2008

Study Completion

January 30, 2008

Last Updated

May 19, 2017

Record last verified: 2017-05