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HMG-CoA Reductase Inhibitor

Atorvastatin and Aspirin for Lynch Syndrome

Phase < 1
Waitlist Available
Led By Michael J Hall, MD, MS
Research Sponsored by Fox Chase Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 weeks
Awards & highlights

Study Summary

This trial will study whether atorvastatin, a common cholesterol-lowering drug, can reduce the risk of colorectal cancer in people with Lynch syndrome.

Eligible Conditions
  • Lynch Syndrome

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Genome-wide expression analyses using RNA-Seq
Proliferation (Ki-67) and apoptosis (active caspase 3) by immunohistochemical staining
Secondary outcome measures
Interventional procedure
Frequency of adverse events among patients administered atorvastatin ± aspirin for 6 weeks
Rate of adherence of healthy patients with Lynch Syndrome to a 6-week of the treatment regimen (atorvastatin ± aspirin).

Trial Design

2Treatment groups
Active Control
Group I: Atorvastatin and AspirinActive Control1 Intervention
Atorvastatin (LIPITOR) 20 milligram tablet and Aspirin 325 mg tablet daily for 6 weeks
Group II: AtorvastatinActive Control1 Intervention
Atorvastatin (LIPITOR) 20 milligram tablet daily for 6 weeks

Find a Location

Who is running the clinical trial?

Fox Chase Cancer CenterLead Sponsor
229 Previous Clinical Trials
38,130 Total Patients Enrolled
Michael J Hall, MD, MSPrincipal InvestigatorFox Chase Cancer Center

Media Library

Atorvastatin (HMG-CoA Reductase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04379999 — Phase < 1
Lynch Syndrome Research Study Groups: Atorvastatin and Aspirin, Atorvastatin
Lynch Syndrome Clinical Trial 2023: Atorvastatin Highlights & Side Effects. Trial Name: NCT04379999 — Phase < 1
Atorvastatin (HMG-CoA Reductase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04379999 — Phase < 1
~7 spots leftby Jun 2025
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