Immune Response in Peripheral Blood of Patients With Colon Cancer

Colorectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00900432
• Other study ID #: 04-0331-01
• Secondary ID: P50CA095060P30CA
• Status: Completed
• Phase: N/A
• First received: May 9, 2009
• Last updated: December 2, 2015
• Start date: July 2004
• Est. completion date: December 2008

Study information

• Verified date: August 2012
• Source: University of Arizona
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 67
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

DISEASE CHARACTERISTICS:

• Diagnosis of colon cancer

PATIENT CHARACTERISTICS:

• Not specified

PRIOR CONCURRENT THERAPY:

• Not specified

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Colorectal Cancer

Intervention

Other:
• immunoenzyme technique

• laboratory biomarker analysis

Locations

Country	Name	City	State
United States	Arizona Cancer Center at University of Arizona Health Sciences Center	Tucson	Arizona

Sponsors (2)

Lead Sponsor	Collaborator
University of Arizona	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quantitation of T cells specific for tumor peptides (carcinoembryonic antigen and MUC1)		3 months	No