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NCT00773097 · ClinicalTrials.gov registry record · Phase 2
Study of the MUC1 Peptide-Poly-ICLC Adjuvant Vaccine in Individuals With Advanced Colorectal Adenoma
A Phase 2 study of Risk for Colorectal Cancer, sponsored by Robert Schoen.
- Completed
- Registry status
- Phase 2
- Development phase
- 46
- Enrollment target
- 1
- Study location
NCT00773097: Completed Phase 2 study of Risk for Colorectal Cancer, sponsored by Robert Schoen.
NCT00773097 is a Phase 2 study of Risk for Colorectal Cancer that has completed, run by Robert Schoen. The registered enrollment target is 46 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (65% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00773097, a Phase 2 study of Risk for Colorectal Cancer, has completed, sponsored by Robert Schoen.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 46 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this study is to evaluate the immune response to MUC1 - poly-ICLC vaccine, an investigational or study vaccine. The MUC1 - poly-ICLC vaccine is being tested in persons with a history of advanced adenomatous polyps, the precursor to colorectal cancer. The MUC1 - poly-ICLC vaccine is being developed to prevent polyps from advancing into colon cancer and to prevent polyps from recurring. MUC1 is mucus that is normally present on the lining of the human colon. However, MUC1 is expressed in a larger amount and in a modified form on adenomatous polyps and colorectal cancer. These changes in MUC1 are thought to be part of the process of progression from adenomas toward cancer. The goal of a vaccine is to help the immune system in the body identify the changes in MUC1 that accompany the progression to cancer and eliminate the abnormal cells that make abnormal MUC1.
Primary Outcome
Evaluation of the immune response to MUC1 peptide vaccine administered with Poly-ICLC, measured by Anti MUC1 antibody, in patients with a history of advanced colorectal adenoma.
Conditions Studied
Interventions
- BIOLOGICAL MUC1 - Poly ICLC
Study Locations (1)
Pennsylvania
- Digestive Disorders Clinic - Pittsburgh
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 46 participants |
| Start Date | 2008-10 |
| Est. Completion | 2012-10 |
| Phase | Phase 2 |
What the finished NCT00773097 record still lists
NCT00773097 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 46 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (65% lower).
The record links to 1 condition, with Risk for Colorectal Cancer appearing as the primary indexed condition, and to 1 intervention - of which MUC1 - Poly ICLC is the first listed.
NCT00773097 reports a single indexed study location in Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT00773097 about?
NCT00773097 is a clinical study titled "Study of the MUC1 Peptide-Poly-ICLC Adjuvant Vaccine in Individuals With Advanced Colorectal Adenoma". The purpose of this study is to evaluate the immune response to MUC1 - poly-ICLC vaccine, an investigational or study vaccine. The MUC1 - poly-ICLC vaccine is being tested in persons with a history of advanced adenomatous polyps, the precursor to colorectal cancer. The MUC1 - poly-ICLC vaccine is be...
What is the current status of trial NCT00773097?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 46 participants. The study started on 2008-10. Estimated completion is 2012-10.
What conditions does trial NCT00773097 study?
This clinical trial studies the following conditions: Risk for Colorectal Cancer.
What interventions are being tested in trial NCT00773097?
The interventions under investigation include: MUC1 - Poly ICLC (BIOLOGICAL).
Who is sponsoring clinical trial NCT00773097?
This trial is sponsored by Robert Schoen, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00773097 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00773097's enrollment target sits among peer trials
46 1286th of 2000 higher than 705 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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