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Study on the Effect of Low-Dose Aspirin in Preventing New or Recurrent Colorectal Polyps in Patients with Lynch Syndrome

Fast replyRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of a daily low-dose of aspirin on preventing new or returning growths in the colon, known as colorectal adenomas, in patients with Lynch syndrome. Lynch syndrome is a genetic condition that increases the risk of developing certain types of cancer, particularly in the colon. The study aims to explore whether taking aspirin daily can help reduce the occurrence of these growths compared to a placebo.

Participants in the study will be randomly assigned to receive either a low dose of aspirin (100 mg or 300 mg) or a placebo. The treatment will be administered in the form of a gastro-resistant tablet, which is designed to dissolve in the intestines rather than the stomach, to help minimize stomach irritation. The study will last for a period of 48 months, during which participants will undergo regular check-ups and procedures to monitor the development of any new colorectal adenomas.

The primary goal of the study is to determine the number of patients who develop at least one adenoma after 48 months of treatment. Secondary goals include measuring the time it takes for adenomas to appear after treatment begins, the number of adenomas based on specific genetic factors, and the overall burden of adenomatous polyps. The study will also track the occurrence of colon cancer and other related factors during the follow-up period. Participants will be monitored closely to ensure their safety and to assess the effectiveness of the aspirin treatment compared to the placebo.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment

    Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying a diagnosis of Lynch syndrome and ensuring a recent colonoscopy has been performed within the last 180 days with all polyps removed.

  2. Step 2

    Medication administration

    Participants are randomly assigned to receive either a low-dose of aspirin or a placebo. The aspirin is administered in two possible dosages: 100 mg or 300 mg per day. The medication is taken orally in the form of a gastro-resistant tablet.

  3. Step 3

    Treatment duration

    The treatment continues for a period of 48 months. During this time, participants are required to adhere to the daily medication regimen as prescribed.

  4. Step 4

    Follow-up assessments

    Regular follow-up assessments are conducted to monitor the development of new or recurrent colorectal adenomas. These assessments include scheduled colonoscopies and chromoendoscopy to evaluate the presence and size of any adenomatous polyps.

  5. Step 5

    Data collection

    Throughout the study, data is collected on various endpoints, including the number of adenomas, the time to onset of any new adenomas, and any side effects experienced. This information is used to assess the effectiveness of the aspirin treatment compared to the placebo.

  6. Step 6

    Completion of study

    At the end of the 48-month period, a final assessment is conducted. This includes a comprehensive review of all collected data to determine the impact of the aspirin treatment on the prevention of colorectal adenomas in patients with Lynch syndrome.

Who can join the trial?

8 criteria

  • Men and women with **Lynch syndrome**, which is a genetic condition that increases the risk of certain types of cancer, must have a change in specific genes called "mismatch repair" genes. If no specific change is found, they should have a personal or family history of Lynch syndrome according to certain criteria.
  • Must be older than 25 years, or older than 18 years if there is an early family history of the condition and a need for a colonoscopy every 2 years.
  • Must be younger than 75 years.
  • Must have had a **colonoscopy** (a test to look inside the colon) within 180 days before joining the study, with all removable polyps taken out.
  • Must agree not to use **aspirin** regularly during the study, which means not taking it for 7 consecutive days for at least 3 weeks per year or for more than 21 days per year.
  • Women who can have children must use effective **contraception**, which can be a hormonal method, an intrauterine device (IUD), or surgical sterilization of the woman or her partner.
  • Must be covered by French Social Security (except AME, which is not accepted).
  • Must have signed an informed consent form, which means they agree to participate in the study after understanding all the details.

Who cannot join the trial?

4 criteria

  • Patients who do not have Lynch syndrome, a genetic condition that increases the risk of certain types of cancer, including colorectal cancer.
  • Patients who do not have colorectal adenomas, which are growths in the colon or rectum that can sometimes turn into cancer.
  • Patients who are not within the specified age range for the study.
  • Patients who are part of a vulnerable population, meaning they may have additional risks or need special protection in a clinical trial.
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Investigated drugs

Aspirin is being studied in this trial to see if taking it daily at a low dose can help prevent new or returning colorectal adenomas in patients with Lynch syndrome. Lynch syndrome is a genetic condition that increases the risk of colorectal cancer. The trial is exploring whether aspirin can have a protective effect against the development of these adenomas, which are precursors to cancer.

What is already known about the treatment

Aspirin – Aspirin is typically administered orally in tablet form. It is currently being studied for its potential preventive effects in patients with Lynch syndrome, particularly in preventing new or recurrent colorectal adenomas. The main therapeutic indication in this context is chemoprevention of colorectal adenomas. At the molecular level, aspirin works by inhibiting enzymes called cyclooxygenases, which play a role in inflammation and cell growth. It is classified as a non-steroidal anti-inflammatory drug (NSAID).

Investigated diseases

  • Colorectal adenomas

    Colorectal adenomas are benign growths that form on the lining of the colon or rectum. They are considered precursors to colorectal cancer, as they can develop into malignant tumors over time. These growths are often discovered during routine colonoscopies and can vary in size and shape. The progression from adenoma to cancer is typically slow, taking several years. Factors such as genetic mutations and lifestyle can influence their development. Regular monitoring and removal of adenomas can help prevent the progression to colorectal cancer.

  • Lynch syndrome

    Lynch syndrome is a hereditary condition that increases the risk of developing colorectal cancer and other types of cancer, often at a younger age than the general population. It is caused by inherited mutations in specific genes responsible for DNA repair. Individuals with Lynch syndrome may develop multiple polyps in the colon, which can progress to cancer if not monitored and managed. The syndrome is also associated with an increased risk of cancers in other organs, such as the uterus and stomach. Regular screening and preventive measures are crucial for managing the risks associated with this condition.

Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-516601-23-00Protocol codeP130937Estimated enrolment852 patientsSponsorAssistance Publique Hopitaux De Paris

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).