Lynch SyndromePhase 2MesaCAPPNCT04920149
Mesalamine for Colorectal Cancer Prevention Program in Lynch Syndrome
A Phase 2 study testing Mesalamine in people with Lynch Syndrome and Colon Cancer, run by Ann-Sofie Backman at 8 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Lynch Syndrome, Colon Cancer, Colon Neoplasm
- What is being tested?
- Mesalamine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 8 sitesin 2 countries
- Study dates
- 21 Mar 2022to 30 Sep 2045
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 16Show fewer
- 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
Trial locations and contacts
8 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
8 sites in 2 countries
Sweden6 sites, 5 recruiting
- Recruiting
Sahlgrenska University Hsospital
Gothenburg, Gothenburg, 416 85
David Ljungman, MD PhD, david.ljungman@vgregion.se
David Ljungman, MD PhD
- Recruiting
Skåne University Hospital
Malmö, Skåne County, 205 02
Rita J Gustafsson, MD PhD, rita.j.gustafsson@skane.se
Rita J Gustafsson, MD PhD
- Recruiting
Ersta Hospital/Ersta Diakoni
Stockholm, 116 91
Ann-Sofie Backman, MD PhD, ann-sofie.backman@erstadiakoni.se
Ann-Sofie Backman, MD PhD
- Active, not recruiting
Karolinska University Hospital
Stockholm, 171 76
- Recruiting
Norrland University Hospital
Umeå, 901 85
Gustav Silander, MD PhD, gustav.silander@regionvasterbotten.se
Gustav Silander, MD PhD
- Not yet recruiting
Akademiska hospital
Uppsala, 751 85
Peter Thelin Schmidt, MD PhD, peter.thelin.schmidt@medsci.uu.se
Peter Thelin Schmidt, MD PhD
Denmark2 sites, 2 recruiting
- Not yet recruiting
Aalborg University Hospital
Aalborg, 9000
Ole Thorlacius-Ussing, MD PhD, otu@rn.dk
Ole Thorlacius-Ussing, MD PhD
- Recruiting
Hvidovre Hospital
Hvidovre, 2650
Lars Joachim Lindberg, MD PhD, lars.joachim.lindberg@regionh.dk
Lars Joachim Lindberg, MD PhD
About this study
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.
Read the 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.
- Conditions
- Lynch Syndrome, Colon Cancer, Colon Neoplasm
- Being tested
- Mesalamine, Placebo
- Medical subject headings
- Colorectal Neoplasms, Hereditary Nonpolyposis, Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MesalamineDrug
Also called Mesalazine, Pentasa sachet, 5-ASA
The IMP will be supplied as sachets with slow-releasing granules.
PlaceboDrug
The IMP will be supplied as sachets with slow-releasing granules.
| Study group | Role | What they receive |
|---|---|---|
| Mesalamine | Experimental | Mesalamine (Mesalazine, Pentasa sachet, 5-ASA) 2 g once daily for 2 years. Receives: Drug: Mesalamine |
| Placebo | Placebo comparator | Placebo for Mesalamine (Mesalazine, Pentasa sachet, 5-ASA) 2 g once daily for 2 years. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: End of treatment at 24 months +/- 1 month
Change in the occurrence of any colorectal neoplasia in LS patients
As above.
Measured: End of study at year 6 +/- 3 months.
Secondary outcomes (4)
Tumour multiplicity
The number of colorectal neoplasia (both benign and malignant tumors) per patient will be tested between groups by an analysis of variance, adjusting for country and history of cancer before randomization. In case of non-normally distributed residuals a suitable transformation to achieve normal distribution is considered. It will be tested whether 5-ASA (low- and high-dose together) reduces the number of any colorectal neoplasia (both benign and malignant tumors; tumor multiplicity) compared to placebo in LS patients at the end of treatment and end of study. Advanced adenomas are defined by a diameter above 1 cm villous or tubulo-villous histology or high grade dysplasia.
Measured: End of treatment at 24 months +/- 1 month
Tumour progress
The tumor progress in 4 ordered stages will be tested between groups stratified for country and history of cancer before randomization.
It will be tested whether 5-ASA reduces tumor progression (compared 4 ordinal stages: no colorectal neoplasia / non-advanced adenoma / advanced adenoma / carcinoma) compared to placebo in LS patients at the end of treatment and end of study. Advanced adenomas are defined by a diameter above 1 cm villous or tubulo-villous histology or high grade dysplasia.
Measured: End of treatment at 24 months +/- 1 month
Treatment effects
The dependence of treatment effects on history of colorectal cancer, sex and patients age will be assessed by modelling interactions between these factors and treatment in the corresponding regression models.
If differences between 5-ASA effects and placebo effects on the occurrence of colorectal neoplasia, tumor multiplicity or tumor progression depend on the history of colorectal cancer, sex and patients age will be investigated.
Measured: End of treatment at 24 months +/- 1 month
Significant findings & illnesses - adverse events
Safety data are described and compared between groups in an exploratory manner to determine the safety concerning 5-ASA in LS patient. Therefore significant findings/illnesses, reported after the start of the study and which meet the definition of an AE, will be recorded in the CRF.
Intention to treat set: This analysis set includes subjects who were randomized (and received at least one dose study drug). This analysis set will be chosen for safety assessment.
Measured: End of treatment at 24 months +/- 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2021
- Study start21 Mar 2022
- Primary completion30 Sep 2032 (estimated)
- Study completion30 Sep 2045 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lynch SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ann-Sofie Backman
- Sponsor type
- University, hospital or other
- Collaborators
- The Swedish Research Council, Karolinska Institutet
- Responsible party
- Sponsor-investigator, Ann-Sofie Backman, Karolinska University Hospital
- Investigators
- Ann-Sofie Backman, MD PhD, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04920149
- Sponsor's protocol ID
- MesaCAPP
- Acronym
- MesaCAPP
- Status last verified
- Dec 2024
- First submitted
- 3 Jun 2021
- Last updated
- 17 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 41213710
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mesalamine for Colorectal Cancer Prevention Program in Lynch Syndrome
- ClinicalTrials.gov ID
- NCT04920149
- Acronym / sponsor ID
- MesaCAPP / MesaCAPP
- Conditions
- Lynch Syndrome, Colon Cancer, Colon Neoplasm
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Ann-Sofie BackmanUniversity, hospital or other
- Collaborators
- The Swedish Research Council, Karolinska Institutet
- Study start
- 21 Mar 2022 (actual)
- Primary completion
- 30 Sep 2032 (estimated)
- Study completion
- 30 Sep 2045 (estimated)
- First posted
- 9 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mesalamine | Experimental | Drug: MesalamineMesalamine (Mesalazine, Pentasa sachet, 5-ASA) 2 g once daily for 2 years. |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo for Mesalamine (Mesalazine, Pentasa sachet, 5-ASA) 2 g once daily for 2 years. |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MesalamineAlso: Mesalazine, Pentasa sachet, 5-ASAThe IMP will be supplied as sachets with slow-releasing granules. | Drug | Mesalamine |
| PlaceboThe IMP will be supplied as sachets with slow-releasing granules. | Drug | Placebo |
Primary outcome
Change in the occurrence of any colorectal neoplasia in LS patients
Time frame: End of treatment at 24 months +/- 1 month
Occurrence of any colorectal neoplasia (both benign and malignant tumors) between groups is described by absolute frequencies and percentages.
Change in the occurrence of any colorectal neoplasia in LS patients
Time frame: End of study at year 6 +/- 3 months.
As above.
4 secondary outcomes
Tumour multiplicity
Time frame: End of treatment at 24 months +/- 1 month
Tumour progress
Time frame: End of treatment at 24 months +/- 1 month
Treatment effects
Time frame: End of treatment at 24 months +/- 1 month
Significant findings & illnesses - adverse events
Time frame: End of treatment at 24 months +/- 1 month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2024.
- Derived from this study: PubMed 41213710Backman 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ann-Sofie Backman, MD PhD principal investigator
Karolinska Institutet
8 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Mesalamine in people with Lynch Syndrome and Colon Cancer, run by Ann-Sofie Backman at 8 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Sweden, Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ann-Sofie Backman, MD PhD (707515285 ext. 46, ann-sofie.backman@ki.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the occurrence of any colorectal neoplasia in LS patients (time frame: End of treatment at 24 months +/- 1 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04920149, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2024.