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ACTIVE NOT RECRUITING
NCT04767984
PHASE2

Testing Atorvastatin to Lower Colon Cancer Risk in Longstanding Ulcerative Colitis

Sponsor: Northwestern University

View on ClinicalTrials.gov

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.

Official title: A Randomized and Placebo-Controlled Phase II Trial Targeting Dominant-Negative Missense Mutant P53 by Atorvastatin for Reducing the Risk of Longstanding Ulcerative Colitis-Associated Cancer

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

42

Start Date

2021-09-24

Completion Date

2026-11-30

Last Updated

2026-01-21

Healthy Volunteers

No

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

Locations (3)

Northwestern University

Chicago, Illinois, United States

University of Chicago Comprehensive Cancer Center

Chicago, Illinois, United States

University of Kansas Cancer Center

Kansas City, Kansas, United States