MMR MutationiCARE4LynchNCT07472686
Small Bowel Capsule Endoscopy in Lynch Syndrome
An observational study of MMR Mutation and Small Bowel Adenoma, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The impact of small bowel (SB) capsule endoscopy (CE) on the screening (followed by diagnosis and treatment) of (pre)neoplastic lesions of the small bowel in Lynch syndrome (LS) patients is unknown. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- MMR Mutation, Small Bowel Adenoma, Small-bowel Adenocarcinoma
- How many people
- 400 participants
- Where
- 1 siteFrance
- Study dates
- 16 Jun 2025to Dec 2026
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients carrying a pathogenic variant of the DNA mismatch repair gene (MMR) (MLH1, MSH2, MSH6, PMS2, EPCAM) with at least one SBCE for screening of small bowel (pre)neoplastic lesions over the study period (Jan 1st 2000 - Dec 31st 2024),
Who may be able to join
- Patient carrying a pathogenic variant of the DNA mismatch repair gene (MMR) (MLH1, MSH2, MSH6, PMS2, EPCAM)
- Capsule endoscopy screening for (pre)neoplastic lesions of the small intestine
- No opposition to the reuse of healthcare data for research purposes
Who cannot join
- Absence of documented MMR gene variant
- Opposition to the study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Center for Digestive Endoscopy, Saint-Antoine Hospital
Paris
Xavier DRAY, MD, PhD, +33 (0) 1 49 28 21 61, xavier.dray@aphp.fr
About this study
Official title: Small Bowel Capsule Endoscopy for (Pre)Neoplastic Lesion Screening in Patients With Lynch Syndrome
The impact of small bowel (SB) capsule endoscopy (CE) on the screening (followed by diagnosis and treatment) of (pre)neoplastic lesions of the small bowel in Lynch syndrome (LS) patients is unknown.
The iCARE4Lynch study is a retrospective cohort of patients carrying a pathogenic variant of the DNA mismatch repair gene (MMR) (MLH1, MSH2, MSH6, PMS2, EPCAM) who had had at least one SBCE for screening of small bowel (pre)neoplastic lesions between January 1st 2000 and December 31 2024.
Read the detailed description
Population study
Participating investigators
Members of the international CApsule endoscopy REsearch (iCARE) group
Objectives The primary objective of the study is to estimate the diagnostic performance of a first (index) SB CE for screening of small bowel (pre)neoplastic lesions in patients with LS.
Secondary objectives are to estimate, in this setting:
- the frequency and type of adverse events related to the performance of SB CE;
- the technical performances of SB CE;
- diagnostic performance of subsequent SB CEs;
- the age at diagnosis of SB (pre)neoplastic lesions
- the therapeutic impact of CE detection of SB lesions
- the frequency of SB (pre)neoplastic lesions found, depending on the type of pathogenic DNA mismatch repair gene variants.
Origin of personal health data (source(s) used) This research focuses on the analysis of data collected as part of the routine clinical care of patients (no additional examination will be requested). Data will be collected from patient medical records (paper and digital).
Personal data circuit and method for protecting the confidentiality of personal data The personal data circuit concerns the use of care data from capsule endoscopy (CE) examination reports in paper files or stored in the Orbis software present in the APHP computer network or the CE software of each associated hospital center.
A correspondence table with order numbers will be used. There will be no circulation or exchange of data. Access to the data is secured at the APHP network and the data will be archived for 15 years in the coordinating center.
Information concerning deceased persons, including that which appears on death certificates, may be processed for research, study or health evaluation purposes, unless the patient has, during his or her lifetime, expressed his or her written refusal.
The vital status of patients will be investigated before data collection (alive or deceased).
Variables and analysis Patient data: Age at SBCE; Gender; Pathogenic variant of MMR gene; History of LS-related cancer; History and type of digestive surgery; First-degree family history (parents, siblings, children) of small bowel adenocarcinoma;
Indication for SBCE: screening, family history, clinical or radiological diagnosis;
Timing and organization of the study, research or evaluation:
Data collected from January 1st 2000 to December 31st 2024. Total study duration: 12 months
- Keywords
- Cancer, Lynch syndrome, Capsule endoscopy, Screening, Small bowel, Small-bowel adenoma, Small-bowel adenocarcinoma, Small-bowel cancer, Small-bowel capsule endoscopy, pathogenic variant, DNA mismatch repair gene (MMR), MLH1, MSH2, MSH6, PMS2, EPCAM
- Medical subject headings
- Colorectal Neoplasms, Hereditary Nonpolyposis, Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
proportion of patients in whom at least one small bowel pre-neoplastic (low or high grade adenoma) or neoplastic (adenocarcinoma) lesion, secondarily proven during follow-up, was identified, compared to the total number of patients with index CE in this
Diagnostic performance of index SBCE
Measured: At the end of the study (12 month)
Secondary outcomes (9)
Proportion of adverse events during SBCE
Measured: At the end of the study (12 month)
Completeness rate to evaluate technical performances of SBCE
completeness rate is the entire small bowel visualized, depending on past surgical history
Measured: At the end of the study (12 month)
Small bowel recording duration to evaluate technical performances of SBCE
Measured: 12 months
Recourse to endoscopic techniques (duodenal release) when the capsule cannot be ingested or ingestion has failed to evaluate technical performances of SBCE
Measured: 12 months
Diagnostic performance of subsequent SBCE
Proportion of patients in whom at least one small bowel pre-neoplastic (low or high grade adenoma) or neoplastic (adenocarcinoma) lesion, secondarily proven during follow-up, was identified on a follow up SBCE, compared to the total number of patients with follow-up SBCE in this setting.
Measured: At the end of the study (12 month)
Age at diagnosis of small bowel (pre)neoplastic lesions
Age at diagnosis of small bowel (pre)neoplastic lesions in patients with LS, monitored by repeat SBCE;
Measured: At the end of the study (12 month)
Frequency of small bowel (pre)neoplastic lesions found by SBCE in patients with LS depending on the type of pathogenic DNA mismatch repair gene variants.
Diagnostic performance according to genetic variants
Measured: At the end of the study (12 month)
Type of treatment of any lesion of (pre)neoplastic appearance of the small bowel detected by SBCE.
Type of treatment: endoscopic, surgical, pharmacological, abstention or other.
Measured: At the end of the study (12 month)
Post-therapeutic follow-up
Post-therapeutic follow-up of any lesion of (pre)neoplastic appearance of the small bowel detected on a SBCE: anatomopathological analysis of any lesion of (pre)neoplastic appearance of the small bowel detected by SBCE, and consequences (cure, recurrence, additional treatments, death).
Measured: At the end of the study (12 month)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2026
- Study start16 Jun 2025
- Primary completionJun 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MMR MutationStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07472686
- Sponsor's protocol ID
- APHP241223
- Acronym
- iCARE4Lynch
- Status last verified
- Mar 2026
- First submitted
- 27 Feb 2026
- Last updated
- 16 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Small Bowel Capsule Endoscopy for (Pre)Neoplastic Lesion Screening in Patients With Lynch Syndrome
- ClinicalTrials.gov ID
- NCT07472686
- Acronym / sponsor ID
- iCARE4Lynch / APHP241223
- Keywords
- Cancer, Lynch syndrome, Capsule endoscopy, Screening, Small bowel, Small-bowel adenoma, Small-bowel adenocarcinoma, Small-bowel cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 16 Jun 2025 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 16 Mar 2026 (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.
The impact of small bowel (SB) capsule endoscopy (CE) on the screening (followed by diagnosis and treatment) of (pre)neoplastic lesions of the small bowel in Lynch syndrome (LS) patients is unknown.
The iCARE4Lynch study is a retrospective cohort of patients carrying a pathogenic variant of the DNA mismatch repair gene (MMR) (MLH1, MSH2, MSH6, PMS2, EPCAM) who had had at least one SBCE for screening of small bowel (pre)neoplastic lesions between January 1st 2000 and December 31 2024.
Detailed description
Population study
Participating investigators
Members of the international CApsule endoscopy REsearch (iCARE) group
Objectives The primary objective of the study is to estimate the diagnostic performance of a first (index) SB CE for screening of small bowel (pre)neoplastic lesions in patients with LS.
Secondary objectives are to estimate, in this setting:
- the frequency and type of adverse events related to the performance of SB CE;
- the technical performances of SB CE;
- diagnostic performance of subsequent SB CEs;
- the age at diagnosis of SB (pre)neoplastic lesions
- the therapeutic impact of CE detection of SB lesions
- the frequency of SB (pre)neoplastic lesions found, depending on the type of pathogenic DNA mismatch repair gene variants.
Origin of personal health data (source(s) used) This research focuses on the analysis of data collected as part of the routine clinical care of patients (no additional examination will be requested). Data will be collected from patient medical records (paper and digital).
Personal data circuit and method for protecting the confidentiality of personal data The personal data circuit concerns the use of care data from capsule endoscopy (CE) examination reports in paper files or stored in the Orbis software present in the APHP computer network or the CE software of each associated hospital center.
A correspondence table with order numbers will be used. There will be no circulation or exchange of data. Access to the data is secured at the APHP network and the data will be archived for 15 years in the coordinating center.
Information concerning deceased persons, including that which appears on death certificates, may be processed for research, study or health evaluation purposes, unless the patient has, during his or her lifetime, expressed his or her written refusal.
The vital status of patients will be investigated before data collection (alive or deceased).
Variables and analysis Patient data: Age at SBCE; Gender; Pathogenic variant of MMR gene; History of LS-related cancer; History and type of digestive surgery; First-degree family history (parents, siblings, children) of small bowel adenocarcinoma;
Indication for SBCE: screening, family history, clinical or radiological diagnosis;
Timing and organization of the study, research or evaluation:
Data collected from January 1st 2000 to December 31st 2024. Total study duration: 12 months
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients carrying a pathogenic variant of the DNA mismatch repair gene (MMR) (MLH1, MSH2, MSH6, PMS2, EPCAM) with at least one SBCE for screening of small bowel (pre)neoplastic lesions over the study period (Jan 1st 2000 - Dec 31st 2024),
Key inclusion criteria (3 listed)
- Patient carrying a pathogenic variant of the DNA mismatch repair gene (MMR) (MLH1, MSH2, MSH6, PMS2, EPCAM)
- Capsule endoscopy screening for (pre)neoplastic lesions of the small intestine
- No opposition to the reuse of healthcare data for research purposes
Key exclusion criteria (2 listed)
- Absence of documented MMR gene variant
- Opposition to the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
proportion of patients in whom at least one small bowel pre-neoplastic (low or high grade adenoma) or neoplastic (adenocarcinoma) lesion, secondarily proven during follow-up, was identified, compared to the total number of patients with index CE in this
Time frame: At the end of the study (12 month)
Diagnostic performance of index SBCE
9 secondary outcomes
Proportion of adverse events during SBCE
Time frame: At the end of the study (12 month)
Completeness rate to evaluate technical performances of SBCE
Time frame: At the end of the study (12 month)
Small bowel recording duration to evaluate technical performances of SBCE
Time frame: 12 months
Recourse to endoscopic techniques (duodenal release) when the capsule cannot be ingested or ingestion has failed to evaluate technical performances of SBCE
Time frame: 12 months
Diagnostic performance of subsequent SBCE
Time frame: At the end of the study (12 month)
Age at diagnosis of small bowel (pre)neoplastic lesions
Time frame: At the end of the study (12 month)
Frequency of small bowel (pre)neoplastic lesions found by SBCE in patients with LS depending on the type of pathogenic DNA mismatch repair gene variants.
Time frame: At the end of the study (12 month)
Type of treatment of any lesion of (pre)neoplastic appearance of the small bowel detected by SBCE.
Time frame: At the end of the study (12 month)
Post-therapeutic follow-up
Time frame: At the end of the study (12 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 16 Mar 2026.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of MMR Mutation and Small Bowel Adenoma, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 3 inclusion and 2 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 16 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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 Xavier DRAY, MD PhD (+33 (0) 1 49 28 21 61, xavier.dray@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
proportion of patients in whom at least one small bowel pre-neoplastic (low or high grade adenoma) or neoplastic (adenocarcinoma) lesion, secondarily proven during follow-up, was identified, compared to the total number of patients with index CE in this (time frame: At the end of the study (12 month)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Mar 2026.