Mesalamine for Colorectal Cancer Prevention Program in Lynch syndrome

Phase 1

• Conditions: Colorectal Cancer Prevention in Lynch syndrome; MedDRA version: 20.0 Level: LLT Classification code 10051981 Term: Lynch syndrome System Organ Class: 100000004850; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2016-003548-35-NL
• Lead Sponsor: Medical University of Vienna

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-05-31
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 540

Inclusion Criteria

- Proven tumor-free (including patients in which the polyps are removed endoscopically) carriers of a germline pathologic mutation on one of the MMR genes including MLH1, MSH2 (including EpCAM) and MSH6.
- Male or female subjects with the age > 30 years
- Signed written informed consent prior to inclusion in the study
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 270
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 270

Exclusion Criteria

- Presence of colonic endoscopically non-removable benign neoplasia (patient can be included if the adenoma is removed)
- Carriers of germline mutations in PMS 2.
- Patients with history of stage 3 and 4 cancer are excluded
- Presence of metastatic disease
- Regular use of Aspirin: daily use of =100mg in more than 3 continuous months within the last year
- Regular use of NSAIDs or COX-2 inhibitors: daily use in more than 3 continuous months within the last year
- Hypersensitivity to 5-ASA
- Patients after total or subtotal colectomy
- Colorectal surgery within the previous 6 months
- Unwillingness to participate or who is considered incompetent to give an informed consent
- Pregnant or breastfeeding women
- Participation in another clinical study investigating another IMP within 1 month prior to screening
- Renal insufficiency (GFR <30ml/min/1.73m2)
- Severe liver disease or liver failure (elevation of liver enzymes above 3xULN)
- Current or history of serious psychiatric disorder or alcohol/drug abuse that in the opinion of the investigator may impact the assessment of
safety, efficacy or protocol adherence
- Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study
participation or ability to comply with study procedures, investigational product administration and, in the judgment of the investigator, would
make the subject inappropriate for entry into this study.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified