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Development and Validation of a Circulating Tumour DNA Marker for Pre-neoplastic Colorectal Tumours.

NCT07776548 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 110

Last updated 2026-08-20

No results posted yet for this study

Summary

The goal of this prospective interventional biomarker development and validation study is to determine whether circulating tumour DNA (ctDNA) can be detected in patients with large pre-neoplastic colorectal lesions undergoing endoscopic resection and whether ctDNA can be used to identify local recurrence after resection.

The main questions it aims to answer are:

* Can advanced colorectal laterally spreading tumours (LSTs) shed detectable ctDNA into the bloodstream before endoscopic resection?
* Can ctDNA measured at the first surveillance colonoscopy detect or predict local recurrence after endoscopic resection?

Participants will:

* Provide a blood sample before their planned endoscopic resection procedure for ctDNA analysis.
* Undergo standard endoscopic resection of their colorectal lesion.
* Allow collection and molecular analysis of tissue samples obtained from the resected lesion.
* Allow researchers to collect clinical, endoscopic, pathological, and molecular data from their medical records for research purposes.

The study does not alter the standard clinical management, resection technique, or surveillance schedule. The only study-specific procedures are blood sample collections performed during routine intravenous catheter placement for the participant's endoscopic procedures.

Conditions

  • Advanced Colorectal Laterally Spreading Tumours (LSTs)

Interventions

DIAGNOSTIC_TEST

Blood Collection for ctDNA Analysis

Blood samples will be collected before endoscopic resection for circulating tumour DNA (ctDNA) analysis. Results will be correlated with tumour tissue sequencing findings and surveillance colonoscopy outcomes.

Sponsors & Collaborators

  • Centre hospitalier de l'Université de Montréal (CHUM)

    lead OTHER

Principal Investigators

  • Roupen Djinbachian, MD, PhD · Centre Hospitalier Universitaire de Montréal (CHUM)

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2027-01-04
Primary Completion
2028-06-30
Completion
2029-01-03

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07776548 on ClinicalTrials.gov