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ACTIVE NOT RECRUITING Phase 2

Testing Atorvastatin to Lower Colon Cancer Risk in Longstanding Ulcerative Colitis

NCT04767984 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 42 participants
Start Date 2021-09-24
Est. Completion 2026-11-30
Phase Phase 2

Sponsor

Northwestern University

1,033 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04767984

The ClinicalTrials.gov registry entry for NCT04767984 describes a study currently listed as active not recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 42 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Northwestern University, which has 1,033 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT04767984 reports 3 study locations spanning 2 distinct geographic areas — top geographies include Illinois, Kansas. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04767984?

This trial is sponsored by Northwestern University, which has 1,033 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial