Ongoing Clinical Trials for Hereditary Non-Polyposis Colorectal Cancer Syndrome
There are currently 2 clinical trials underway investigating preventive treatments for hereditary non-polyposis colorectal cancer syndrome. These studies are testing medications that may help reduce the development of colorectal tumors in patients with this genetic condition. The trials are taking place in Denmark, Sweden, and France. (Also known as: Lynch syndrome)
Clinical trial locations
- Denmark
- France
- Sweden
Study on Mesalamine to Prevent Colorectal Cancer in Patients with Lynch Syndrome
This trial is testing whether mesalamine, also known as 5-ASA, can help prevent colorectal tumors in patients with this genetic condition. The medication is being compared to a placebo over a 24-month period, with an additional 3-month follow-up.
Main inclusion criteria: Participants must have confirmed Lynch syndrome and be tumor-free carriers of a genetic mutation in one of the MMR genes (MLH1, MSH2, or MSH6). They must be older than 30 years. Women of childbearing potential must use highly effective birth control and have a negative pregnancy test before starting. All participants must sign an informed consent form.
Main exclusion criteria: The study excludes patients who do not have Lynch syndrome, those unwilling or unable to undergo regular colonoscopy procedures, anyone with a history of allergic reactions to mesalamine or similar medications, pregnant or breastfeeding women, and those currently participating in another clinical trial. Patients with any medical condition that would make participation unsafe are also excluded.
Focus and goals: The primary goal is to determine whether mesalamine can reduce the occurrence of colorectal tumors, both benign and malignant, compared to placebo. Regular colonoscopies will be conducted throughout the study to monitor for any signs of tumor development. The research will also gather information on the number of tumors per patient, tumor progression, and whether treatment effects vary based on factors like previous cancer history, gender, and age. Safety data will be collected and compared between the mesalamine and placebo groups.
Investigational drug: Mesalamine is an anti-inflammatory medication administered orally in the form of prolonged-release granules at a dose of 2 grams daily. It works by reducing inflammation in the colon, which may help lower the chance of developing tumors. The medication is being studied for its potential to prevent colorectal cancer in individuals with this genetic condition.
Study on the Effect of Low-Dose Aspirin in Preventing New or Recurrent Colorectal Polyps in Patients with Lynch Syndrome
This trial investigates whether daily low-dose aspirin can prevent new or recurring growths in the colon, known as colorectal adenomas, in patients with Lynch syndrome. The study will last 48 months.
Main inclusion criteria: Men and women with confirmed Lynch syndrome must have a change in specific mismatch repair genes or have a personal or family history meeting certain criteria. Participants must be older than 25 years (or older than 18 with early family history requiring colonoscopy every 2 years) and younger than 75 years. They must have had a colonoscopy within 180 days before joining, with all removable polyps removed. Participants must agree not to use aspirin regularly during the study. Women of childbearing potential must use effective contraception. Patients must be covered by French Social Security and sign an informed consent form.
Main exclusion criteria: The study excludes patients who do not have Lynch syndrome, those without colorectal adenomas, patients outside the specified age range, and those considered part of a vulnerable population who may need special protection in a clinical trial.
Focus and goals: The primary goal 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, 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 undergo regular colonoscopies and chromoendoscopy to monitor for new polyps.
Investigational drug: Aspirin is administered orally in gastro-resistant tablets at doses of either 100 mg or 300 mg per day. These tablets are designed to dissolve in the intestines rather than the stomach to minimize stomach irritation. Aspirin is a non-steroidal anti-inflammatory drug that works by inhibiting enzymes involved in inflammation and cell growth. The trial is exploring whether aspirin can have a protective effect against the development of adenomas, which are precursors to colorectal cancer.
Summary
Both ongoing trials focus on preventive strategies for patients with hereditary non-polyposis colorectal cancer syndrome. The mesalamine study is being conducted in Scandinavia (Denmark and Sweden), while the aspirin study is based in France. Both studies are investigating whether anti-inflammatory medications can reduce the development of colorectal tumors or polyps in patients with this genetic condition. The mesalamine trial has a shorter duration of 24 months, while the aspirin study extends over 48 months. Both trials require regular colonoscopy monitoring and exclude pregnant or breastfeeding women. These studies represent important efforts to find effective prevention strategies for individuals at increased risk of colorectal cancer due to inherited genetic mutations.
