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Statins

Atorvastatin for Ulcerative Colitis

Phase 2
Recruiting
Led By Seema A Khan
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Eastern Cooperative Oncology Group (ECOG) performance status =< 1 (Karnofsky >= 70%)
Participants must have ulcerative colitis with > 8 years history and clinical remission (including the clinical remission for an extraintestinal manifestation/complication) confirmed by yearly surveillance endoscopy examination (Mayo grading < 3)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights

Study Summary

This trial is studying atorvastatin as a possible treatment for ulcerative colitis to help prevent large intestinal cancer.

Who is the study for?
Adults aged 18-70 with longstanding ulcerative colitis and a specific P53 mutation, in clinical remission for at least 8 years. They must not have used statins or had chemotherapy within the last year or two respectively, no recent corticosteroid use, and cannot be pregnant. Participants should have stable cholesterol levels and agree to contraception during the study.Check my eligibility
What is being tested?
The trial is testing if Atorvastatin can lower colon cancer risk in patients with ulcerative colitis who are at increased risk of large intestinal cancer. It involves taking Atorvastatin versus a placebo while monitoring health through biopsies, blood tests, questionnaires, and biospecimen collection.See study design
What are the potential side effects?
Atorvastatin may cause muscle pain or weakness, liver enzyme changes leading to potential liver damage, digestive issues like nausea or constipation, increased blood sugar levels which could signal diabetes risk, and possible confusion or memory problems.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am mostly self-sufficient and can carry out daily activities.
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I have had ulcerative colitis for over 8 years and am in remission, confirmed by yearly endoscopy.
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I had hepatitis C but am cured, or I'm being treated with no detectable virus.
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My hepatitis B is under control with treatment.
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My cholesterol is below 240 mg/dl and my LDL-C is under 190 mg/dl.
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I can take care of myself but might not be able to do heavy physical work.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Reduction in mutant p53 staining in biopsy samples obtained during colonoscopies done before and after intervention
Secondary outcome measures
Analysis of spectrum, hotspot and load of TP53 gene mutations
Banking of colorectal specimens
Clinical efficacy on UC related symptoms
+3 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Arm I (atorvastatin, biospecimen collection)Experimental Treatment4 Interventions
Patients receive atorvastatin PO QD for 12 months. Patients also undergo colonoscopy with biopsy, and collection of blood on the trial.
Group II: Arm II (placebo, biospecimen collection)Placebo Group4 Interventions
Patients receive placebo PO QD for 12 months. Patients also undergo colonoscopy with biopsy, and collection of blood on the trial.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Biospecimen Collection
2004
Completed Phase 2
~1700
Atorvastatin Calcium
2023
Completed Phase 4
~240

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,665 Previous Clinical Trials
40,925,784 Total Patients Enrolled
3 Trials studying Ulcerative Colitis
443 Patients Enrolled for Ulcerative Colitis
Seema A KhanPrincipal InvestigatorNorthwestern University
2 Previous Clinical Trials
232 Total Patients Enrolled
Seema KhanStudy ChairNorthwestern University
8 Previous Clinical Trials
417 Total Patients Enrolled

Media Library

Atorvastatin Calcium (Statins) Clinical Trial Eligibility Overview. Trial Name: NCT04767984 — Phase 2
Ulcerative Colitis Research Study Groups: Arm I (atorvastatin, biospecimen collection), Arm II (placebo, biospecimen collection)
Ulcerative Colitis Clinical Trial 2023: Atorvastatin Calcium Highlights & Side Effects. Trial Name: NCT04767984 — Phase 2
Atorvastatin Calcium (Statins) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04767984 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

To what extent could Atorvastatin Calcium pose a risk to patients?

"Due to the lack of clinical evidence demonstrating Atorvastatin Calcium's effectiveness, our team assessed its safety as a 2 on a scale from 1 to 3."

Answered by AI

Could you enumerate the previous experiments conducted using Atorvastatin Calcium?

"Atorvastatin Calcium has been studied since as early as 2005, when it was first tested at OHSU Hospital. To date, 660 studies have concluded their results with an additional 70 still recruiting participants - many of these in the area surrounding Chicago."

Answered by AI

Are octogenarians accepted into the current trial?

"Applicants that meet the age requirement of being between 18 and 70 are welcome to join this medical trial."

Answered by AI

Can I be a part of this investigation?

"Seventy individuals aged 18 to 70 with current ulcer conditions can take part in this trial. Furthermore, the must be clinically remissive of UC and have had a DALM resected by endoscopic mucosa resection. Lastly, they should have an ECOG performance status ≤ 1 (Karnofsky ≥70%)."

Answered by AI

Is this pioneering experiment a unique endeavor?

"Since 2005, Atorvastatin Calcium has been the subject of clinical research. Merck Sharp & Dohme LLC sponsored its first study in that year with 80 participants and it was subsequently approved for Phase 4 drug trials. Today, 70 studies are actively conducted at 162 sites worldwide across 28 different countries."

Answered by AI

Is this research seeking participants at the moment?

"According to clinicaltrials.gov, this trial is actively recruiting participants; the initial post was made on September 24th 2021 and subsequently amended on October 12th 2022."

Answered by AI

What maladies is Atorvastatin Calcium typically administered to address?

"Atorvastatin Calcium is regularly used to treat disorders of the lipid profile, though it can also be beneficial in managing postoperative thromboembolism, anginal pain, and transient ischemic attack."

Answered by AI

What is the extent of the current cohort for this research endeavor?

"70 eligible participants are required to complete this study. It is possible to take part in it from two different sites, namely the University of Chicago Comprehensive Cancer Center and National Cancer Institute, both located within Illinois and Maryland respectively."

Answered by AI

Who else is applying?

What state do they live in?
Illinois
How old are they?
65+
What site did they apply to?
Northwestern University
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
Testing Atorvastatin to Lower Colon Cancer Risk in Longstanding Ulcerative Colitis
2021. "Testing Atorvastatin to Lower Colon Cancer Risk in Longstanding Ulcerative Colitis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04767984.
All > Colorectal Cancer San Diego > Lipitor
~14 spots leftby Dec 2024
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