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Clinical Trials/NCT00900432
NCT00900432CompletedNot Applicable

Immune Studies of Peripheral Blood From Patients With Malignant Disease Gastrointestinal Tract

University of Arizona1 site in 1 country67 target enrollmentStarted: July 2004Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
67
Locations
1
Primary Endpoint
Quantitation of T cells specific for tumor peptides (carcinoembryonic antigen and MUC1)

Study Overview

Brief Summary

RATIONALE: Studying samples of blood from patients with cancer in the laboratory may help doctors learn more about changes that may occur in the immune system that may help kill cancer cells.

PURPOSE: This laboratory study is looking at anticancer immune responses in the peripheral blood of patients with colon cancer.

Detailed Description

OBJECTIVES:

  • Quantify T cells specific for tumor peptides (carcinoembryonic antigen and MUC1) from the peripheral blood of patients with colon cancer.

OUTLINE: This is an open-label study.

Patients undergo blood collection at time of follow-up, surgery, thoracentesis, paracentesis, or leukapheresis (≤ 5 times per year). Blood is analyzed for tumor peptides (carcinoembryonic antigen and MUC1), circulating cytokines, and lymphocyte response by ELISA, ELISPOT, or intracellular flow.

PROJECTED ACCRUAL: A total of 140 patients will be accrued for this study.

Study Design

Study Type
Observational
Observational Model
Case Only
Time Perspective
Prospective

Eligibility Criteria

Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Quantitation of T cells specific for tumor peptides (carcinoembryonic antigen and MUC1)

Time Frame: 3 months

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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