Participants sought for studies Investigating whether a known intestinal drug can prevent high hereditary risk of bowel cancer (Lynch syndrome)
We are seeking participants with Lynch syndrome for a research study. The study will investigate whether a known intestinal drug can prevent cell changes in the colon and thus prevent colon cancer.
Lynch syndrome means that you have several relatives who have had bowel or uterine cancer at a young age and have been tested for heredity using a blood test (genetic test). The gene makes it more difficult to repair cellular damage and therefore puts people at risk of developing various forms of cancer early in life. Therefore, these individuals are offered screening programmes with colonoscopies to detect cancer early.
Since colonoscopy does not protect against the development of cancer, but only aims to detect early cancer, it would be good to be able to add a protective medicine that prevents the development of cell changes. A protective medicine should cause as few side effects as possible if it is to be taken as a preventive measure.
Mesalazine is used to treat and prevent inflammatory bowel disease and is well tolerated by both children and adults who receive daily treatment. This study will test whether mesalazine prevents cell changes in Lynch syndrome and whether it is well tolerated for prevention.
How it works
- The study participant is randomised to take the study drug mesalazine or a placebo.
- The participant does not know which drug is assigned.
- The study drug is given for two years and is a granule (small grains).
- Before starting the study, colonoscopy, blood and faecal samples are taken. During the study, colonoscopy is performed after one year and after two years.
- Further sampling with blood samples, bowel samples, faecal samples and control visits are carried out according to the protocol during the study.
The samples are taken partly to check the participant's health but also to study markers to see if cancer can be found early.
Some criteria for participation:
- You must not have had surgery to remove part of your bowel.
- You must have a heredity test and have been diagnosed with Lynch syndrome.
To be considered as a study participant, you need to do your control scopies during the two-year study period at Ersta Hospital in Stockholm, Östra Hospital in Gothenburg, Norrland University Hospital in Umeå, Skåne University Hospital in Malmö or Hvidovre Hospital in Copenhagen. These hospitals have research units with research nurses and doctors.
Whether or not you can take part in the study is something you discuss with the research nurse and the doctor in charge of the research.
Before you agree to participate in the study, you should read the patient information and also receive oral information at the study centre.
The study is funded by the Swedish Research Council, the Swedish Cancer Society and ALF funds. This is an academic study.
Contact
Send an email to the FoU-unit at Ersta sjukhus (fou-enheten@erstadiakoni.se) to register your interest to participate. They will help you with contacts to the right study centre and send you complete patient information.
Processing of personal data
Your personal data is processed for the purposes of this study in accordance with GDPR (General Data Protection Regulation). The legal entity responsible for processing of your personal data is Karolinska Institutet. The Data Protection Officer can be reached at dataskyddsombud@ki.se. The data will be analyzed on a group level, handled confidentially and it will be stored in a secure database at Karolinska Institutet. You can terminate your participation in the study at any time.