Clinical trial · Observational
Circulating Tumour DNA (ctDNA) in Patients With Colorectal Cancer and the Relationship to Imaging Features of Extramural Venous Invasion
NCT02579278CI-TRIAL-00081679ctDNArecruitingClinicalTrials.gov clinicaltrialsProvenance
- 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)
This study does not involve randomization or treatment. Eligible patients have colorectal adenocarcinoma with no metastases eligible for curative surgery. A pre operative staging scan must have been completed within 6 weeks prior to surgery. Two x 20ml blood samples will be taken from each patient, one prior to and one during or within 24hrs after surgery. Patients are annually followed up to 3 years.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Rectal Cancer | Malignant Rectal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Blood sample (mrEMVI negative patient) | Other | — | UNRESOLVED |
| Blood sample (mrEMVI positive patient) | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- mrEMVI positive rectal tumours
- description
- Patients will be registered whose rectal tumours are mrEMVI positive (i.e. EMVI is present in baseline and post-chemoradiotherapy MRI scans).
- interventionNames
- Other: Blood sample (mrEMVI positive patient)
- label
- mrEMVI negative rectal tumours
- description
- Patients registered who were mrEMVI positive at baseline MRI but have become mrEMVI negative post-chemoradiotherapy.
- interventionNames
- Other: Blood sample (mrEMVI negative patient)
Primary outcomes (1)
- measure
- To determine if there is a link between EMVI status and ctDNA
- timeFrame
- Up to 2 years
- description
- Proportion of patients who are EMVI positive demonstrating higher % mutation frequency of circulating cell-free and tumour specific DNA compared with patients who are EMVI negative.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 16 Years
Show eligibility criteria text
Inclusion Criteria: 1. Have a biopsy-confirmed colorectal adenocarcinoma 2. Is eligible for curative surgery 3. Has no metastatic disease on CT scan 4. Has completed pre-operative staging scan within six weeks prior to surgery 5. Have provided written informed consent to participate in the study 6. Be aged 16 years or over Exclusion Criteria: 1. Have metastatic disease (including resectable liver metastases) 2. Have a synchronous second malignancy 3. Are contraindicated for any imaging able to determine EMVI status
References
Publications (0)
Data not yet available
No reference posted for this study.