Mesalamine for Colorectal Cancer Prevention Program in Lynch Syndrome

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Brief Title

Mesalamine for Colorectal Cancer Prevention Program in Lynch Syndrome

Official Title

Mesalamine for Colorectal Cancer Prevention Program in Lynch Syndrome

Brief Summary

      Multicenter, multinational, randomized, 2-arm, double-blind, phase II clinical study with
      2000mg mesalamine, or placebo for prevention of colorectal neoplasia in Lynch Syndrome
      patients during and following daily intake for 2 years.
    

Detailed Description

      This is a multicenter, multinational, randomized, 2-arm, double-blind, phase II clinical
      study with 2000mg mesalamine (5-ASA) or placebo in LS patients for a 2-year treatment. 260
      tumor free carriers of a known genetic mutation in a major MMR gene (including patients in
      which the polyps are endoscopically removed) will be randomized 1:1 to receive 2000mg
      mesalamine or placebo. Patients will be identified through local or national registries and
      through collaboration with sites. Tumor free patients, assessed by white light high
      resolution colonoscopy, will be randomized to the study. Blood and stool samples will be
      collected for analysis of microbiota, ctDNA and potential biomarkers. Biopsies of the normal
      tissue of ascending colon and rectum will be taken at the first and the last colonoscopy.

      The aim of the study is to investigate the effect of regular treatment with mesalamine
      (5-ASA) on the occurrence of any colorectal neoplasia, tumor multiplicity (the number of
      detected adenomas/carcinomas) and tumor progression in LS patients.

      Tumor multiplicity and tumor progression (severity of the neoplastic lesions) will be
      investigated.
    

Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

Change in the occurrence of any colorectal neoplasia in LS patients

Secondary Outcome

 Tumour multiplicity

Condition

Lynch Syndrome

Intervention

Mesalamine

Study Arms / Comparison Groups

 Mesalamine
Description:  Mesalamine (Mesalazine, Pentasa sachet, 5-ASA) 2 g once daily for 2 years.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

260

Start Date

August 9, 2021

Completion Date

October 15, 2038

Primary Completion Date

October 15, 2028

Eligibility Criteria

        Inclusion Criteria:

          -  Proven tumor-free (including patients in which the polyps are removed endoscopically)
             carriers of a germline pathologic mutation in one of the MMR genes including MLH1,
             MSH2 (including EpCAM) and MSH6

          -  Male or female subjects with the age of 30 years or older

          -  Females who have been post-menopausal more than one (1) year or females of
             childbearing potential using a highly efficient method of contraception with less than
             1% failure rate (i.e. oral hormonal contraceptives, hormone implants, hormone
             injections, sterilization, hormonal or copper intrauterine device,
             sterilized/vasectomized partner, or diaphragm in combination with a condom, spermicide
             or birth control pills) or should agree to abstain from heterosexual activity during
             treatment period. Females of childbearing potential must have a negative pregnancy
             test at screening and before randomization.

          -  Signed written informed consent prior to inclusion in the study

        Exclusion Criteria:

          -  Presence of colorectal endoscopically non-removable benign neoplasia (patient can be
             included if the adenoma is removed)

          -  Carriers of germline mutations in PMS2

          -  Patients with history of stage 3 and 4 CRC are excluded

          -  Presence of metastatic disease

          -  Regular use of aspirin/ASA: 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 any subtotal or total 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 IMP safety and efficacy or
             protocol adherence

          -  Prior history of myocarditis or pericarditis. Other severe acute or chronic medical
             condition such as severe chronic lung (COPD, including asthma, kidney and heart
             diseases) 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
      

Gender

All

Ages

30 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Ann-Sofie Backman, MD PhD, 707515285, [email protected]

Location Countries

Denmark

Location Countries

Denmark

Administrative Informations


NCT ID

NCT04920149

Organization ID

MesaCAPP


Responsible Party

Sponsor-Investigator

Study Sponsor

Ann-Sofie Backman

Collaborators

 The Swedish Research Council

Study Sponsor

Ann-Sofie Backman, MD PhD, Principal Investigator, Karolinska University Hospital


Verification Date

July 2021