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NCT00578721 · ClinicalTrials.gov registry record · Phase 2
Trial of Aspirin and Arginine Restriction in Colorectal Cancer
A Phase 2 study, sponsored by University of California, Irvine.
- Completed
- Registry status
- Phase 2
- Development phase
- 24
- Enrollment target
NCT00578721 is a Phase 2 study that has completed, run by University of California, Irvine. The registered enrollment target is 24 participants.
The verdict
NCT00578721, a Phase 2 study, has completed, sponsored by University of California, Irvine.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 24 participants
- Enrollment target
Study Summary
The purpose of this research study is to understand the effects of oral aspirin taken daily with an arginine-restricted diet on certain colorectal cancer biomarkers in treated colorectal cancer patients. Patients with colorectal cancer are at high risk for recurrence and for development of secondary colorectal cancers in the future. Specific chemicals (polyamines, prostaglandins) in the body referred to as biomarkers can be measured to help understand a person's risk for developing colorectal cancer. Specific biomarkers associated with colorectal cancer have been identified in prior laboratory studies. By measuring these predefined biomarkers before and after the study intervention, we can assess how they are affected by the intervention, and gain knowledge about their usefulness in colorectal cancer patients on clinical trial. This study is a Phase IIa clinical biomarker study, using oral aspirin 325 mg taken daily with an arginine-restricted diet designed to reduce arginine intake by at least 30% during the 12-week study period. The biomarkers will be obtained from patient by performing endoscopy (a procedure used to look at the inside of the bowel, rectum and colon) and biopsy (taking samples of tissue), phlebotomy (drawing blood), and urine collection. Biopsies are done to evaluate changes in tissue content that may relate to early events in colon cancer formation. This was the procedure used to diagnose your condition initially. There will be 24 patients enrolled into this study performed through University of California Irvine Medical Center.
Interventions
- DRUG Aspirin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2008-09-24 |
| Est. Completion | 2013-11-26 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00578721
The ClinicalTrials.gov registry entry for NCT00578721 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 24 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of California, Irvine, which has 368 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Aspirin is the first listed.
NCT00578721 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00578721 about?
NCT00578721 is a clinical study titled "Trial of Aspirin and Arginine Restriction in Colorectal Cancer". The purpose of this research study is to understand the effects of oral aspirin taken daily with an arginine-restricted diet on certain colorectal cancer biomarkers in treated colorectal cancer patients. Patients with colorectal cancer are at high risk for recurrence and for development of secondary...
What is the current status of trial NCT00578721?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 24 participants. The study started on 2008-09-24. Estimated completion is 2013-11-26.
What interventions are being tested in trial NCT00578721?
The interventions under investigation include: Aspirin (DRUG).
Who is sponsoring clinical trial NCT00578721?
This trial is sponsored by University of California, Irvine, which has 368 total clinical trials registered on ClinicalTrials.gov.
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