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NCT04767984 · ClinicalTrials.gov registry record · Phase 2
Testing Atorvastatin to Lower Colon Cancer Risk in Longstanding Ulcerative Colitis
A Phase 2 study of Ulcerative Colitis and Colorectal Carcinoma, sponsored by Northwestern University.
- Active
- Registry status
- Phase 2
- Development phase
- 42
- Enrollment target
- 3
- Study locations
NCT04767984: Active Phase 2 study of Ulcerative Colitis and Colorectal Carcinoma, sponsored by Northwestern University.
NCT04767984 is a Phase 2 study of Ulcerative Colitis and Colorectal Carcinoma that is active but no longer recruiting, run by Northwestern University. The registered enrollment target is 42 participants, below the 2,057-participant average among 122 other Ulcerative Colitis trials with a reported enrollment target (98% lower). The trial reports 3 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04767984, a Phase 2 study of Ulcerative Colitis and Colorectal Carcinoma, is active but no longer recruiting, sponsored by Northwestern University.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 42 participants
- Enrollment target
- 3
- Study locations
Study Summary
This phase II trial studies the effect of atorvastatin in treating patients with ulcerative colitis who have a dominant-negative missense P53 mutation and are at risk of developing large intestinal cancer. Patients with ulcerative colitis are known to have an increased risk of developing large intestinal cancer. Better ways to control ulcerative colitis and more knowledge about how to prevent colon cancer are needed. Atorvastatin is a drug used to lower the amount of cholesterol in the blood and to prevent stroke, heart attack, and angina (chest pain). It blocks an enzyme that helps make cholesterol in the body. It also causes an increase in the breakdown of cholesterol. The information gained from this study may help doctors learn more about atorvastatin as an agent in cancer prevention, and may help to improve public health.
Primary Outcome
Counted as p53 positive cells/100 epithelial cells under at least 5 high powered fields per slide or 100 crypts or 2000 cells/slide per biopsy, measured by immunohistochemistry (IHC) staining. The level of biomarker expression will be determined by chromogenic staining. Because multiple samples will be obtained per participant, participant-level %p53 mutation will be summarized as the average %p53 across these samples. Descriptive statistics will be used to summarize changes in each arm, as well
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- OTHER Questionnaire Administration
- DRUG Placebo Administration
- DRUG Atorvastatin Calcium
- PROCEDURE Biopsy of Colon
Study Locations (3)
Illinois
- Northwestern University - Chicago
- University of Chicago Comprehensive Cancer Center - Chicago
Kansas
- University of Kansas Cancer Center - Kansas City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 42 participants |
| Start Date | 2021-09-24 |
| Est. Completion | 2026-11-30 |
| Phase | Phase 2 |
What the registry record for NCT04767984 still lists
NCT04767984 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 42 participants, a relatively small participant target, below the 2,057-participant average among 122 other Ulcerative Colitis trials with a reported enrollment target (98% lower).
The record links to 2 conditions, with Ulcerative Colitis appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.
NCT04767984 reports a single indexed study location in Illinois, Kansas.
Frequently Asked Questions
What is clinical trial NCT04767984 about?
NCT04767984 is a clinical study titled "Testing Atorvastatin to Lower Colon Cancer Risk in Longstanding Ulcerative Colitis". This phase II trial studies the effect of atorvastatin in treating patients with ulcerative colitis who have a dominant-negative missense P53 mutation and are at risk of developing large intestinal cancer. Patients with ulcerative colitis are known to have an increased risk of developing large intes...
What is the current status of trial NCT04767984?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 42 participants. The study started on 2021-09-24. Estimated completion is 2026-11-30.
What conditions does trial NCT04767984 study?
This clinical trial studies the following conditions: Ulcerative Colitis, Colorectal Carcinoma.
What interventions are being tested in trial NCT04767984?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Questionnaire Administration (OTHER), Placebo Administration (DRUG), Atorvastatin Calcium (DRUG), Biopsy of Colon (PROCEDURE).
Who is sponsoring clinical trial NCT04767984?
This trial is sponsored by Northwestern University, which has 1,209 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04767984 being conducted?
This trial has 3 study locations across Illinois, Kansas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04767984's enrollment target sits among peer trials
42 93rd of 122 higher than 30 of 122 other Ulcerative Colitis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Ulcerative Colitis 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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