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Videocapsule Endoscopy in Lynch Syndrome

StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Notable Primary completion date: Dec 31, 2025 to Dec 31, 2028
    • Study completion date: Dec 31, 2026 to Dec 31, 2029
    v4
  2. Minor Re-verified, no change to tracked fieldsv3
  3. Minor Study description shortened, about 647 wordsv2
  4. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Background Lynch syndrome is caused by a pathogenic variant in one of the four Mismatch Repair genes (MMR): MLH1, MSH2/Epcam, MSH6, or PMS2. These pathogenic variants confer a higher risk of developing colorectal and other cancers, including small bowel cancer. The risk of developing a small bowel adenocarcinoma is about 100 times higher compared to individuals without Lynch syndrome, and the lifetime risk of small bowel cancer is estimated at 4,2%. The diagnosis of a small bowel cancer depends on videocapsule endoscopy (VCE). This device is swalled so that it can record images of the small bowel, which are then stored on a wearable device for about 8 hours. The capsule is then expelled in the feces while the images are transferred to a computer to be analysed. To date, there is conflicting evidence on the efficacy of small bowel cancer screening with VCE Rationale: this registry study will collect prospective data from patients with LS undergoing VCE Aim: evaluate the incidence of neoplastic and pre-neoplastic lesions in patients with LS during a VCE-based small bowel cancer screening study Design: this is a multicentric, observational study that analyzes data from diagnostic techniques already approved. Patients will not undergo diagnostic procedures beyond what would be recommended by clinical practice.
Trial Details
NCT Number NCT05704010
Lead Sponsor San Raffaele University
Collaborators: Unita' di Gastroenterologia - Policlinico Universitario di Bari, Centro di Riferimento Oncologico - Aviano, Humanitas Hospital, Italy
Conditions
(from sponsor)
Lynch Syndrome, Lynch Syndrome I, Lynch Syndrome II, MLH1 Gene Mutation, MSH2 Gene Mutation, MSH6 Gene Mutation, PMS2 Gene Mutation, Small Bowel Adenocarcinoma
Related terms Colorectal Neoplasms, Hereditary Nonpolyposis, Lynch Syndrome II
Enrollment 100 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov