Colorectal CancerNCT00900432
Immune Response in Peripheral Blood of Patients With Colon Cancer
An observational study of Colorectal Cancer, run by University of Arizona at 1 site in United States.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- immunoenzyme technique and laboratory biomarker analysis
- How many people
- 67 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2004to Dec 2008
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: colon cancer
DISEASE CHARACTERISTICS:
- Diagnosis of colon cancer
PATIENT CHARACTERISTICS:
- Not specified
PRIOR CONCURRENT THERAPY:
- Not specified
Trial locations and contacts
1 site in 1 country.
United States1 site
Arizona Cancer Center at University of Arizona Health Sciences Center
Tucson, Arizona, 85724-5024
About this study
Official title: Immune Studies of Peripheral Blood From Patients With Malignant Disease Gastrointestinal Tract
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.
Read the 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.
- Conditions
- Colorectal Cancer
- Being tested
- immunoenzyme technique, laboratory biomarker analysis
- Keywords
- recurrent colon cancer, stage I colon cancer, stage II colon cancer, stage III colon cancer, stage IV colon cancer
- Medical subject headings
- Colorectal Neoplasms, Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
immunoenzyme techniqueOther
laboratory biomarker analysisOther
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantitation of T cells specific for tumor peptides (carcinoembryonic antigen and MUC1)
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2009 (estimated)
- Study startJul 2004
- Primary completionDec 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by University of ArizonaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arizona
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Michael Demeure, MD, Study chair, University of Arizona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00900432
- Sponsor's protocol ID
- 04-0331-01
- Other IDs
- P50CA095060, P30CA023074, UARIZ-04-81
- Status last verified
- Aug 2012
- First submitted
- 9 May 2009
- Last updated
- 3 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immune Studies of Peripheral Blood From Patients With Malignant Disease Gastrointestinal Tract
- ClinicalTrials.gov ID
- NCT00900432
- Acronym / sponsor ID
- 04-0331-01
- Conditions
- Colorectal Cancer
- Keywords
- recurrent colon cancer, stage I colon cancer, stage II colon cancer, stage III colon cancer, stage IV colon cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- University of ArizonaUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jul 2004
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 12 May 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- colon cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| immunoenzyme technique | Other | – |
| laboratory biomarker analysis | Other | – |
Primary outcome
Quantitation of T cells specific for tumor peptides (carcinoembryonic antigen and MUC1)
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Demeure, MD study chair
University of Arizona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Cancer, run by University of Arizona at 1 site in United States.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quantitation of T cells specific for tumor peptides (carcinoembryonic antigen and MUC1) (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2015.