Status:
COMPLETED
Atorvastatin ± Aspirin in Lynch Syndrome Syndrome
Lead Sponsor:
Fox Chase Cancer Center
Collaborating Sponsors:
Prevent Cancer Foundation
Conditions:
Lynch Syndrome
Eligibility:
All Genders
18-75 years
Phase:
EARLY_PHASE1
Brief Summary
The goal of this study is to investigate that a common cholesterol lowering agent (atorvastatin) alone or combining with a nonsteroidal anti-inflammatory drug (aspirin) would reduce the risk of colore...
Detailed Description
This is an exploratory biomarker trial to assess the ability of atorvastatin (common cholesterol lowering agent) alone or combining with aspirin (a nonsteroidal anti-inflammatory drug) to reduce the r...
Eligibility Criteria
Inclusion
- Subjects who are 18 years of age or older
- Able to read and sign an informed consent document in English
- Eligible subjects will have molecular evidence of Lynch Syndrome (mutation in MLH1, MSH2, MSH6, EPCAM or PMS2)
- History of colorectal cancer if surgically cured and \> 1 year from completion of adjuvant chemotherapy
Exclusion
- Are \<18 years of age
- Unable to read and sign an informed consent document in English
- Have active cancer or are less than 3 years post hormonal maintenance therapy for cancer
- Have statin intolerance or contraindication for aspirin or atorvastatin use
- Are pregnant or are actively breast feeding
Key Trial Info
Start Date :
September 10 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 4 2025
Estimated Enrollment :
43 Patients enrolled
Trial Details
Trial ID
NCT04379999
Start Date
September 10 2018
End Date
August 4 2025
Last Update
August 7 2025
Active Locations (1)
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1
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111