BridgeMD
AAS-Lynch - Assessment of the effect of a daily chemoprevention by aspirin low-dose of new or recurrent colorectal adenomas in patients with Lynch syndrome
EU CTIS ID: 2024-516601-23-00
What this study is testing
To explore a preventive effect of aspirin low-dose (100 or 300 mg/d) compared with placebo on apparition of a new or recurrent colorectal adenomas in patients with Lynch syndrome.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Men and women with Lynch syndrome bearing an alteration of “mismatch repair” genes or,when no characteristic alteration has been found, with a personal or family history of Lynch syndrome according to modified Amsterdam criteria
- Aged more than 25 years, et aged more than 18 years with an early familial history and any reason to perform a colonoscopy every 2 years
- Aged less than 75 years
- A colonoscopy done within 180 days prior to inclusion, with removal of all polyps endoscopically resectable
- Patients accept that not use aspirin regularly all along the study (during 7 consecutive days during at least 3 weeks per year or during more than 21 days per year)
- Effective contraception for womens of childbearing age, defined by a hormonal method, an intrauterine device (IUD), or surgical sterilization of the patient or her partner
You likely can't join if
- History of total colectomy
- Gastrointestinal bleeding linked to ulcerative disease in the previous 12 months before inclusion
- Gastric pathology deemed significant by the investigator and not corrected by appropriate treatment
- Uncontrolled hypertension
- Kidney failure (creatinine clearance < 30 ml/mn)
- Severe hepatic impairment (defined as TP <70%)
See the full eligibility criteria
- Men and women with Lynch syndrome bearing an alteration of “mismatch repair” genes or,when no characteristic alteration has been found, with a personal or family history of Lynch syndrome according to modified Amsterdam criteria
- Aged more than 25 years, et aged more than 18 years with an early familial history and any reason to perform a colonoscopy every 2 years
- Aged less than 75 years
- A colonoscopy done within 180 days prior to inclusion, with removal of all polyps endoscopically resectable
- Patients accept that not use aspirin regularly all along the study (during 7 consecutive days during at least 3 weeks per year or during more than 21 days per year)
- Effective contraception for womens of childbearing age, defined by a hormonal method, an intrauterine device (IUD), or surgical sterilization of the patient or her partner
- Patients covered by French Social Security (AME not accepted)
- Patients signed informed consent
- History of total colectomy
- Gastrointestinal bleeding linked to ulcerative disease in the previous 12 months before inclusion
- Gastric pathology deemed significant by the investigator and not corrected by appropriate treatment
- Uncontrolled hypertension
- Kidney failure (creatinine clearance < 30 ml/mn)
- Severe hepatic impairment (defined as TP <70%)
- Severe uncontrolled heart failure
- G6PD deficiency
- Recent diagnosis of colorectal cancer implying a specific management
- Menorrhagia deemed significant by the investigator and not corrected by appropriate treatment
- Pregnancy or breast feeding
- Adenomatous polyposis related to a known alteration of the APC gene or the MYH gene
- Any disease susceptible to interfere with protocol-defined follow-up or to impair the comprehension of the information provided by the protocol and informed consent
- Patient waiting for or have been signified a justice decision
- Participation to another clinical trial during the 12 weeks before inclusion
- Allergy to aspirin (including a history of asthma induced by the administration of salicylates or substances with similar activity, including non-steroidal anti-inflammatory)
- Allergy to one food coloring potentially used in a chromo-endoscopy (indigo carmine, for example)
- Need for a prolonged treatment (prevention of cardio-vascular risk) or repeated treatments (recurring migraines) using aspirin or another non-steroidal anti-inflammatory drug (NSAID)
- Need for a prolonged and high-dose systemic glucocorticoid therapy
- Known disease affecting primary hemostasis or coagulation (gastrointestinal bleeding, hemorrhagic stroke and thrombocytopenia history)
- Need for a prolonged anticoagulant, antiplatelet agents, anagrelide, uricosurics, probenecid, ticagrelor, nicorandil, defibrotide, clopidogrel, ticlopidine, ticagrelor, ibrutinib, or cobimetinib
- History of gastro-duodenal ulcer
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.