Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT07838246 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

Liquid Biopsy Biomarkers for Endoscopic Surveillance in Lynch Syndrome

Study acronym: BioLynch
StatusCompleted
PhaseNot specified
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor Study First Submitted
Lynch syndrome (LS) is an autosomal dominant hereditary condition that markedly increases the risk of colorectal cancer (CRC) and other malignancies. Standard surveillance relies on colonoscopy every 1-2 years starting at age 20-25 years, an invasive and costly procedure that may become burdensome during lifelong follow-up and may miss interval cancers. This prospective, single-institution, observational study aims to identify minimally invasive plasma, stool, and urine biomarkers that could improve the detection of early colorectal lesions in individuals with LS and help refine surveillance protocols. Biomarker analyses include microsatellite instability (MSI) and MMR-related frameshift mutations in circulating tumor DNA, plasma and stool microRNA profiling, stool microbiome analysis, and exploratory urine cell-free DNA banking. Patients with genetically confirmed LS followed at Fondazione IRCCS Istituto Nazionale dei Tumori will be enrolled and followed for 24 months, undergoing surveillance colonoscopy at baseline, 12 months, and 24 months, with periodic venous blood sampling and stool, urine, and tissue collection according to protocol.
Trial Details
NCT Number NCT07838246
Lead Sponsor Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Conditions
(from sponsor)
Lynch Syndrome, Hereditary Nonpolyposis Colorectal Cancer, HNPCC, Colorectal Cancer (CRC), Colorectal Neoplasms
Related terms Colorectal Neoplasms, Colorectal Neoplasms, Hereditary Nonpolyposis, Microsatellite Instability, Turcot syndrome
Enrollment 109 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov