Status:
COMPLETED
Studying Tissue Samples From Patients With Stage II Colon Cancer Treated on Clinical Trial CLB-9581
Lead Sponsor:
Alliance for Clinical Trials in Oncology
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Colorectal Cancer
Eligibility:
All Genders
18+ years
Brief Summary
This research trial studies tissue samples from patients with stage II colon cancer treated on Cancer and Leukemia Group B (CALGB)-9581 or CALGB-90903. Studying samples of tissue from patients with ca...
Detailed Description
PRIMARY OBJECTIVES: I. To evaluate the impact of loss of p21 and mutations in p53 on the relationship between higher intake of a Western dietary pattern (manifested by higher red meat and total fat i...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
July 1 2007
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 1 2019
Estimated Enrollment :
2059 Patients enrolled
Trial Details
Trial ID
NCT00897429
Start Date
July 1 2007
End Date
February 1 2019
Last Update
February 19 2019
Active Locations (1)
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1
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115