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Testing Atorvastatin to Lower Colon Cancer Risk in Longstanding Ulcerative Colitis

NCT04767984 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2026-01-21

No results posted yet for this 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.

Conditions

Interventions

DRUG

Atorvastatin Calcium

Given PO

PROCEDURE

Biopsy of Colon

Undergo colonoscopy with biopsy

PROCEDURE

Biospecimen Collection

Undergo collection of blood samples

DRUG

Placebo Administration

Given PO

OTHER

Questionnaire Administration

Ancillary studies

Sponsors & Collaborators

Principal Investigators

  • Stephen B Hanauer, MD · Northwestern University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-24
Primary Completion
2025-12-04
Completion
2026-11-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04767984 on ClinicalTrials.gov