Studying Tissue Samples From Patients With Stage II Colon Cancer Treated on Clinical Trial CLB-9581

Plain-language summary

This study examined tissue samples, using laboratory biomarker analysis, from Stage II colon cancer patients previously treated on the CLB-9581 (CALGB 9581) clinical trial. It included patients enrolled on CALGB 9581 or 89803 with sufficient samples available. Run by the Alliance for Clinical Trials in Oncology, it was a study without an assigned phase and has been completed.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

N/A

Status

Completed

Sponsor

Alliance for Clinical Trials in Oncology

Intervention

laboratory biomarker analysis

Start date

7/1/2007

Estimated completion

2/1/2019

Countries

United States

Related genes

Locations

• Boston, United States

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

Inclusion Criteria:

* Registration to CALGB 9581 or 89803
* Samples present within the CALGB Pathology Coordinating Office (PCO) or at the institutions providing treatment that are sufficient to meet study aims
* Institutional Review Board (IRB) review and approval at the institution where the laboratory work will be performed is required
* CALGB does not require that a separate consent form be signed for this study:

  * The subject population to be studied in this protocol includes patients selected from either of the following CALGB treatment protocols: CALGB 9581 or 89803; all such patients have signed (or will sign) a written informed consent document meeting all federal, state, and institutional guidelines as part of entry into those trials
  * All samples to be studied are obtained and stored as part of the patient's respective treatment trial; the material and data obtained from the patient's protocol record will be used to obtain appropriate clinical information; in no instance will the patient be contacted directly
  * There should be no physical, psychological, social, or legal risks associated with this study; no invasive procedures are recommended or requested
  * All appropriate and necessary procedures will be utilized to maintain confidentiality; all patients who have had samples submitted for analysis will have their CALGB study number used to identify specimens
  * This study does not require direct patient contact and no specific risk or benefits to individuals involved in the trial are anticipated; it is likely, however, that the information gained will substantially help similar patients in the future