Immune Response in Peripheral Blood of Patients With Colon Cancer
| Tracking Information | |||||
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| First Received Date ICMJE | May 9, 2009 | ||||
| Last Updated Date | August 13, 2012 | ||||
| Start Date ICMJE | July 2004 | ||||
| Primary Completion Date | December 2008 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Quantitation of T cells specific for tumor peptides (carcinoembryonic antigen and MUC1) [ Time Frame: 3 months ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE |
Quantitation of T cells specific for tumor peptides (carcinoembryonic antigen and MUC1) [ Designated as safety issue: No ] | ||||
| Change History | Complete list of historical versions of study NCT00900432 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Immune Response in Peripheral Blood of Patients With Colon Cancer | ||||
| Official Title ICMJE | Immune Studies of Peripheral Blood From Patients With Malignant Disease Gastrointestinal Tract | ||||
| 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. |
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| Detailed Description | OBJECTIVES:
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. |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Case-Only Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Probability Sample | ||||
| Study Population | colon cancer |
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| Condition ICMJE | Colorectal Cancer | ||||
| Intervention ICMJE |
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| Study Group/Cohort (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 67 | ||||
| Completion Date | December 2008 | ||||
| Primary Completion Date | December 2008 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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| Gender | Both | ||||
| Ages | Not Provided | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00900432 | ||||
| Other Study ID Numbers ICMJE | 04-0331-01, P50CA095060, P30CA023074, UARIZ-04-81 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| Responsible Party | University of Arizona | ||||
| Study Sponsor ICMJE | University of Arizona | ||||
| Collaborators ICMJE | National Cancer Institute (NCI) | ||||
| Investigators ICMJE |
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| Information Provided By | University of Arizona | ||||
| Verification Date | August 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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