Clinical trial · Interventional
Development and Validation of a Circulating Tumour DNA Marker for Pre-neoplastic Colorectal Tumours.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Colorectal Laterally Spreading Tumours (LSTs) | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Blood Collection for ctDNA Analysis | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- ctDNA-LST Study Cohort
- description
- 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.
- interventionNames
- Diagnostic Test: Blood Collection for ctDNA Analysis
Primary outcomes (1)
- measure
- Pre-resection ctDNA Detection Rate
- timeFrame
- Baseline
- description
- 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.
Secondary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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: * Known concurrent or prior colorectal cancer, or another active malignancy that could contribute circulating tumour DNA. * Lesion \< 10 mm. * Inability to provide informed consent.
References
Publications (0)
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