Clinical trial · Observational
Small Bowel Capsule Endoscopy in Lynch Syndrome
Small Bowel Capsule Endoscopy for (Pre)Neoplastic Lesion Screening in Patients With Lynch Syndrome
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Lynch Syndrome | — | UNRESOLVED | — |
| MMR Mutation | — | UNRESOLVED | — |
| Small-bowel Adenocarcinoma | Small Intestinal Adenocarcinoma | ALIAS | 0.90 |
| Small Bowel Adenoma | Small Intestinal Adenoma | ALIAS | 0.90 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- 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
- timeFrame
- At the end of the study (12 month)
- description
- Diagnostic performance of index SBCE
Secondary outcomes (9)
- measure
- Proportion of adverse events during SBCE
- timeFrame
- At the end of the study (12 month)
- measure
- Completeness rate to evaluate technical performances of SBCE
- timeFrame
- At the end of the study (12 month)
- description
- completeness rate is the entire small bowel visualized, depending on past surgical history
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * Absence of documented MMR gene variant * Opposition to the study
References
Publications (0)
Data not yet available