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Atorvastatin ± Aspirin in Lynch Syndrome Syndrome

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Conditions

Lynch SyndromeHNPCCMLH1MSH2MSH6PMS2EPCAMLYNCH

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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 colorectal cancer (CRC) in high-risk individuals with Lynch syndrome.

Official Title

Impact of Atorvastatin ± Aspirin on Colorectal Biomarkers in Patients With Lynch Syndrome: a Pilot Study

Quick Facts

Study Start:2018-09-10
Study Completion:2025-08-04
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT04379999

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 75 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Subjects who are 18 years of age or older
  2. * Able to read and sign an informed consent document in English
  3. * Eligible subjects will have molecular evidence of Lynch Syndrome (mutation in MLH1, MSH2, MSH6, EPCAM or PMS2)
  4. * History of colorectal cancer if surgically cured and \> 1 year from completion of adjuvant chemotherapy
  1. * Are \<18 years of age
  2. * Unable to read and sign an informed consent document in English
  3. * Have active cancer or are less than 3 years post hormonal maintenance therapy for cancer
  4. * Have statin intolerance or contraindication for aspirin or atorvastatin use
  5. * Are pregnant or are actively breast feeding

Contacts and Locations

Principal Investigator

Michael J Hall, MD, MS
PRINCIPAL_INVESTIGATOR
Fox Chase Cancer Center

Study Locations (Sites)

Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
United States

Collaborators and Investigators

Sponsor: Fox Chase Cancer Center

  • Michael J Hall, MD, MS, PRINCIPAL_INVESTIGATOR, Fox Chase Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2018-09-10
Study Completion Date2025-08-04

Study Record Updates

Study Start Date2018-09-10
Study Completion Date2025-08-04

Terms related to this study

Keywords Provided by Researchers

  • HNPCC
  • MLH1
  • MSH2
  • MSH6
  • PMS2
  • EPCAM
  • LYNCH

Additional Relevant MeSH Terms

  • Lynch Syndrome