NCT04920149

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for phase_2

Timeline
236mo left

Started Mar 2022

Longer than P75 for phase_2

Geographic Reach
2 countries

8 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress18%
Mar 2022Sep 2045

First Submitted

Initial submission to the registry

June 3, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 9, 2021

Completed
10 months until next milestone

Study Start

First participant enrolled

March 21, 2022

Completed
10.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2032

Expected
13 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2045

Last Updated

December 17, 2024

Status Verified

December 1, 2024

Enrollment Period

10.5 years

First QC Date

June 3, 2021

Last Update Submit

December 12, 2024

Conditions

Lynch SyndromeColon CancerColon Neoplasm

Outcome Measures

Primary Outcomes (2)

  • Change in the occurrence of any colorectal neoplasia in LS patients

    Occurrence of any colorectal neoplasia (both benign and malignant tumors) between groups is described by absolute frequencies and percentages.

    End of treatment at 24 months +/- 1 month

  • Change in the occurrence of any colorectal neoplasia in LS patients

    As above.

    End of study at year 6 +/- 3 months.

Secondary Outcomes (4)

  • Tumour multiplicity

    End of treatment at 24 months +/- 1 month

  • Tumour progress

    End of treatment at 24 months +/- 1 month

  • Treatment effects

    End of treatment at 24 months +/- 1 month

  • Significant findings & illnesses - adverse events

    End of treatment at 24 months +/- 1 month

Study Arms (2)

Mesalamine

EXPERIMENTAL

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

Drug: Mesalamine

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

MesalamineDRUG

The IMP will be supplied as sachets with slow-releasing granules.

Also known as: Mesalazine, Pentasa sachet, 5-ASA
Mesalamine
PlaceboDRUG

The IMP will be supplied as sachets with slow-releasing granules.

Placebo

Eligibility Criteria

Age30 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Aalborg University Hospital

Aalborg, 9000, Denmark

NOT YET RECRUITING

Hvidovre Hospital

Hvidovre, 2650, Denmark

RECRUITING

Sahlgrenska University Hsospital

Gothenburg, Gothenburg, 416 85, Sweden

RECRUITING

Skåne University Hospital

Malmo, Skåne County, 205 02, Sweden

RECRUITING

Ersta Hospital/Ersta Diakoni

Stockholm, 116 91, Sweden

RECRUITING

Karolinska University Hospital

Stockholm, 171 76, Sweden

ACTIVE NOT RECRUITING

Norrland University Hospital

Umeå, 901 85, Sweden

RECRUITING

Akademiska hospital

Uppsala, 751 85, Sweden

NOT YET RECRUITING

Related Publications (1)

  • Backman AS, Frank A, Lindberg LJ, Ljungman D, Silander G, Gustafsson RJ, Bozso T, Schmidt PT, Ingre M, Mittlbock M, Lowbeer C, Marsal J, Lindblom A, Tham E, Therkildsen C, Gasche C; International MesaCAPP Study Group. Mesalamine for Colorectal Cancer Prevention Programme in Lynch syndrome (MesaCAPP): a multicentre, multinational, randomised, two-arm, double-blind, phase II clinical study with mesalamine or placebo in carriers with Lynch syndrome - a study protocol. BMJ Open. 2025 Nov 9;15(11):e100082. doi: 10.1136/bmjopen-2025-100082.

    PMID: 41213710DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms, Hereditary NonpolyposisColonic Neoplasms

Interventions

Mesalamine

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsNeoplastic Syndromes, HereditaryDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesDNA Repair-Deficiency DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

meta-AminobenzoatesAminobenzoatesBenzoatesAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsAminosalicylic AcidsSalicylatesHydroxybenzoatesHydroxy AcidsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPhenols

Study Officials

  • Ann-Sofie Backman, MD PhD

    Karolinska Institutet

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ann-Sofie Backman, MD PhD

CONTACT

707515285ann-sofie.backman@ki.se

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Consultant gastroenterology

Study Record Dates

First Submitted

June 3, 2021

First Posted

June 9, 2021

Study Start

March 21, 2022

Primary Completion (Estimated)

September 30, 2032

Study Completion (Estimated)

September 30, 2045

Last Updated

December 17, 2024

Record last verified: 2024-12

Locations

DK(2)SE(6)