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NCT02134925 · ClinicalTrials.gov registry record · Phase 2
Vaccine Therapy in Treating Patients With Newly Diagnosed Advanced Colon Polyps
A Phase 2 study of Colorectal Carcinoma and Colorectal Adenoma, sponsored by National Cancer Institute (NCI).
- Active
- Registry status
- Phase 2
- Development phase
- 110
- Enrollment target
- 7
- Study locations
NCT02134925: Active Phase 2 study of Colorectal Carcinoma and Colorectal Adenoma, sponsored by National Cancer Institute (NCI).
NCT02134925 is a Phase 2 study of Colorectal Carcinoma and Colorectal Adenoma that is active but no longer recruiting, run by National Cancer Institute (NCI). The registered enrollment target is 110 participants, below the 1,094-participant average among 53 other Colorectal Carcinoma trials with a reported enrollment target (90% lower). The trial reports 7 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02134925, a Phase 2 study of Colorectal Carcinoma and Colorectal Adenoma, is active but no longer recruiting, sponsored by National Cancer Institute (NCI).
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 110 participants
- Enrollment target
- 7
- Study locations
Study Summary
This randomized phase II clinical trial studies how well MUC1 peptide-poly-ICLC adjuvant vaccine works in treating patients with newly diagnosed advanced colon polyps (adenomatous polyps). Adenomatous polyps are growths in the colon that may develop into colorectal cancer over time. Vaccines made from peptides may help the body build an effective immune response to kill polyp cells. MUC1 peptide-poly-ICLC adjuvant vaccine may also prevent the recurrence of adenomatous polyps and may prevent the development of colorectal cancer.
Primary Outcome
The ratio of the week 12 to week 0 IgG levels will be calculated and compared between the MUC1 vaccine and placebo. The Wilcoxon Rank-Sum test will be used. For all measurements of response (i.e. the primary endpoint), the 95% confidence intervals will also be provided.
Conditions Studied
Interventions
- OTHER Quality-of-Life Assessment
- OTHER Saline
- OTHER Laboratory Biomarker Analysis
- BIOLOGICAL MUC1 Peptide-Poly-ICLC Vaccine
Study Locations (7)
Pennsylvania
- Thomas Jefferson University Hospital - Philadelphia
- Fox Chase Cancer Center - Philadelphia
- University of Pittsburgh Cancer Institute (UPCI) - Pittsburgh
Massachusetts
- Massachusetts General Hospital Cancer Center - Boston
Minnesota
- Mayo Clinic in Rochester - Rochester
Missouri
- Kansas City Veterans Affairs Medical Center - Kansas City
Other
- University of Puerto Rico - San Juan
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 110 participants |
| Start Date | 2014-06-23 |
| Est. Completion | 2026-03-06 |
| Phase | Phase 2 |
What the registry record for NCT02134925 still lists
NCT02134925 is an interventional study that assigns participants to a tested intervention. The registered 110 participants enrollment target is mid-sized for trials with a published cap, below the 1,094-participant average among 53 other Colorectal Carcinoma trials with a reported enrollment target (90% lower).
The record links to 4 conditions, with Colorectal Carcinoma appearing as the primary indexed condition, and to 4 interventions - of which Quality-of-Life Assessment is the first listed.
NCT02134925 lists 7 locations in 5 states (Pennsylvania, Massachusetts, Minnesota).
Frequently Asked Questions
What is clinical trial NCT02134925 about?
NCT02134925 is a clinical study titled "Vaccine Therapy in Treating Patients With Newly Diagnosed Advanced Colon Polyps". This randomized phase II clinical trial studies how well MUC1 peptide-poly-ICLC adjuvant vaccine works in treating patients with newly diagnosed advanced colon polyps (adenomatous polyps). Adenomatous polyps are growths in the colon that may develop into colorectal cancer over time. Vaccines made fr...
What is the current status of trial NCT02134925?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 110 participants. The study started on 2014-06-23. Estimated completion is 2026-03-06.
What conditions does trial NCT02134925 study?
This clinical trial studies the following conditions: Colorectal Carcinoma, Colorectal Adenoma, Colorectal Adenoma With Severe Dysplasia, Colorectal Tubulovillous Adenoma.
What interventions are being tested in trial NCT02134925?
The interventions under investigation include: Quality-of-Life Assessment (OTHER), Saline (OTHER), Laboratory Biomarker Analysis (OTHER), MUC1 Peptide-Poly-ICLC Vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT02134925?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02134925 being conducted?
This trial has 7 study locations across Massachusetts, Minnesota, Missouri, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Colorectal Carcinoma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02134925's enrollment target sits among peer trials
110 30th of 53 higher than 24 of 53 other Colorectal Carcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Colorectal Carcinoma 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.
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