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Not yet recruitingNCT07776548ctDNA-LSTUpdated Aug 20, 2026

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

An interventional study of Blood Collection for ctDNA Analysis in Advanced Colorectal Laterally Spreading Tumours (LSTs), sponsored by Centre hospitalier de l'Université de Montréal (CHUM). Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-20.

Sponsored by Centre hospitalier de l'Université de Montréal (CHUM) · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
110
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

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.

02

Conditions studied

  • Advanced Colorectal Laterally Spreading Tumours (LSTs)
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Age ≥ 18 years.
  • Referred for resection of a large (≥ 10 mm) colorectal laterally spreading tumour (LST).
  • Lesion judged amenable to endoscopic resection by the treating endoscopist.
  • Able to provide written informed consent.

Exclusion criteria

Exclusion Criteria:

  • Known concurrent or prior colorectal cancer, or another active malignancy that could contribute circulating tumour DNA.
  • Lesion \< 10 mm.
  • Inability to provide informed consent.
04

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
110 participants (estimated)

Study arms

  • Experimental
    ctDNA-LST Study Cohort

    Participants with large colorectal laterally spreading tumours (LSTs) undergoing standard-of-care endoscopic resection will provide blood samples before resection. Tumour tissue and blood samples will be analyzed to develop and evaluate a patient-specific circulating tumour DNA (ctDNA) assay for detection of advanced pre-neoplastic colorectal lesions and local recurrence after resection.

    Diagnostic Test: Blood Collection for ctDNA Analysis

Interventions

  • Diagnostic testBlood 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.

05

What researchers measure

Primary outcomes

  1. Pre-resection ctDNA Detection Rate

    Detection of circulating tumour DNA (ctDNA) in the pre-resection plasma sample using a tumour-informed assay. A positive result is defined according to the prespecified threshold for detected tumour-specific variants. The primary outcome is the proportion of evaluable lesions with detectable ctDNA prior to endoscopic resection.

    Time frame: Baseline

Secondary outcomes

  1. Local recurrence according to pre-resection ctDNA status

    Proportion of patients with local recurrence at the first surveillance colonoscopy stratified by pre-resection ctDNA status (positive vs negative).

    Time frame: 6 months

  2. Quantitative pre-resection ctDNA signal

    Distribution of quantitative plasma ctDNA measurements (variant allele fraction and/or tumor molecules per mL) in evaluable lesions.

    Time frame: Baseline

  3. ctDNA detection rate by lesion characteristics

    Pre-resection ctDNA detection rate according to lesion size, histology, dysplasia grade, morphology, and location.

    Time frame: Baseline

06

Study locations

No study locations are listed for this record.

07

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07776548
Lead sponsor
Centre hospitalier de l'Université de Montréal (CHUM)
Responsible party
Sponsor
First posted
Aug 20, 2026
Start date
Jan 4, 2027 (estimated)
Primary completion
Jun 30, 2028 (estimated)
Completion
Jan 3, 2029 (estimated)
Last update
Aug 20, 2026

Study contacts

Roupen Djinbachian, MD, PhD
Contact
roupen.djinbachian.med@ssss.gouv.qc.ca
514-890-8000
Samira Hanin
Contact
samira.hanin.chum@ssss.gouv.qc.ca
514-890-8000 ext. 30916
Roupen Djinbachian, MD, PhD
principal investigator · Centre Hospitalier Universitaire de Montréal (CHUM)

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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