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Immune Response in Peripheral Blood of Patients With Colon Cancer

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00900432
First Posted: May 12, 2009
Last Update Posted: December 3, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of Arizona
  Purpose

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.


Condition Intervention
Colorectal Cancer Other: immunoenzyme technique Other: laboratory biomarker analysis

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Immune Studies of Peripheral Blood From Patients With Malignant Disease Gastrointestinal Tract

Further study details as provided by University of Arizona:

Primary Outcome Measures:
  • Quantitation of T cells specific for tumor peptides (carcinoembryonic antigen and MUC1) [ Time Frame: 3 months ]

Enrollment: 67
Study Start Date: July 2004
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
colon cancer
Criteria

DISEASE CHARACTERISTICS:

  • Diagnosis of colon cancer

PATIENT CHARACTERISTICS:

  • Not specified

PRIOR CONCURRENT THERAPY:

  • Not specified
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00900432


Locations
United States, Arizona
Arizona Cancer Center at University of Arizona Health Sciences Center
Tucson, Arizona, United States, 85724-5024
Sponsors and Collaborators
University of Arizona
National Cancer Institute (NCI)
Investigators
Study Chair: Michael Demeure, MD University of Arizona
  More Information

Responsible Party: University of Arizona
ClinicalTrials.gov Identifier: NCT00900432     History of Changes
Other Study ID Numbers: 04-0331-01
P50CA095060 ( U.S. NIH Grant/Contract )
P30CA023074 ( U.S. NIH Grant/Contract )
UARIZ-04-81 ( Other Identifier: CDR0000491215 )
First Submitted: May 9, 2009
First Posted: May 12, 2009
Last Update Posted: December 3, 2015
Last Verified: August 2012

Keywords provided by University of Arizona:
recurrent colon cancer
stage I colon cancer
stage II colon cancer
stage III colon cancer
stage IV colon cancer

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases