Videocapsule Endoscopy in Lynch Syndrome

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorSan Raffaele University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Pathogenic germline variant in one of the MMR genes (MLH1, MSH2/Epcam, MSH6, or PMS2).

Disqualifiers

Patients younger than 18 years of age

Patients unwilling or unable to provide informed consent

Patients with prior small bowel surgery

Patients with a contraindication to VCE

Trial design

Design model

Single group

Treatments tested in this trial

  • Video capsule endoscopy

    Device

    Video capsule endoscopy every 2 years

Treatment groups

100 Participants
are divided into 1 treatment group
Group A: Lynch SyndromeExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Small bowel adenocarcinoma

Annual incidence

Time frame
10 years
2

Small bowel adenoma

Annual incidence

Time frame
10 years

Secondary outcomes

Other outcomes

Sponsors and contacts

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San Raffaele University

Lead sponsor

Unita' di Gastroenterologia - Policlinico Universitario di Bari

Collaborator

Centro di Riferimento Oncologico - Aviano

Collaborator

Humanitas Hospital, Italy

Collaborator