Completed

Tumor Replication Error (RER) Status and Outcome in a Colon Cancer Adjuvant Chemotherapy Trial

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What is being collected

Genetic Data

+ genetic Data

Collected from today forward - Prospective
GeneticDNA Samples
Who is being recruted

Colonic Diseases+9

+ Digestive System Diseases

+ Digestive System Neoplasms

See all eligibility criteria
How is the trial designed

Case-Only

Examining characteristics of individuals with a disease in order to identify genetic or environmental factors contributing to the condition.
Observational
Study Start: August 1998
See protocol details

Summary

Principal SponsorAlliance for Clinical Trials in Oncology
Last updated: July 6, 2016
Sourced from a government-validated database.Claim as a partner

Study start date: August 1, 1998

Actual date on which the first participant was enrolled.

OBJECTIVES: Determine the relationship between disease free survival, overall survival, and tumor replication error status for patients who have received adjuvant chemotherapy for colon cancer on CALGB protocol 8896. Determine the prognostic and predictive values for response to this therapy in these patients.

NCT00003571
Principal SponsorAlliance for Clinical Trials in Oncology
Last updated: July 6, 2016
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

300 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Case-only

These studies focus only on individuals who have a specific disease. Researchers examine patterns—often genetic or environmental—to uncover what might be linked to the condition.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Colonic DiseasesDigestive System DiseasesDigestive System NeoplasmsGastrointestinal DiseasesGastrointestinal NeoplasmsIntestinal DiseasesIntestinal NeoplasmsNeoplasmsNeoplasms by SiteRectal DiseasesColonic NeoplasmsColorectal Neoplasms

Criteria

DISEASE CHARACTERISTICS: Patients who received chemotherapy for colon cancer as part of CALGB protocol 8896 Underwent an initial resection for adenocarcinoma of the colon and were determined to have a high risk of tumor recurrence based upon nodal disease or local extension of tumor with obstruction or perforation due to tumor Surgical specimen blocks available, including tumor tissue and normal tissue

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 44 locations

Veterans Affairs Medical Center - Birmingham

Birmingham, United StatesOpen Veterans Affairs Medical Center - Birmingham in Google Maps

University of California San Diego Cancer Center

La Jolla, United States

Veterans Affairs Medical Center - San Francisco

San Francisco, United States

UCSF Cancer Center and Cancer Research Institute

San Francisco, United States
Completed44 Study Centers