Circulating Tumour DNA (ctDNA) in Patients With Colorectal Cancer and the Relationship to Imaging Features of Extramural Venous Invasion

Study Overview
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Brief Summary
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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.

Detailed Description
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A multicentre observational study, ctDNA aims to provide the evidence base for metatstatic disease being caused by vascular methods of spread by determining if there is a link between EMVI status and ctDNA

Official Title
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Circulating Tumour DNA (ctDNA) in Patients With Colorectal Cancer and the Relationship to Imaging Features of Extramural Venous Invasion

Conditions
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Cancer, Rectal Cancer

Intervention / Treatment
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* Other: Blood sample (mrEMVI positive patient)
* Other: Blood sample (mrEMVI negative patient)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Have a biopsy-confirmed colorectal adenocarcinoma Is eligible for curative surgery Has no metastatic disease on CT scan Has completed pre-operative staging scan within six weeks prior to surgery Have provided written informed consent to participate in the study Be aged 16 years or over Exclusion Criteria: Have metastatic disease (including resectable liver metastases) Have a synchronous second malignancy Are contraindicated for any imaging able to determine EMVI status

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| mrEMVI positive rectal tumours<br>Patients will be registered whose rectal tumours are mrEMVI positive (i.e. EMVI is present in baseline and post-chemoradiotherapy MRI scans). | Other: Blood sample (mrEMVI positive patient)<br>* Two blood samples are taken from each patient with mrEMVI positive tumours post chemoradiotherapy. One pre-surgery and one during surgery from a peripheral vein.<br>|
| mrEMVI negative rectal tumours<br>Patients registered who were mrEMVI positive at baseline MRI but have become mrEMVI negative post-chemoradiotherapy. | Other: Blood sample (mrEMVI negative patient)<br> <br> * Other names: Two blood samples are taken from each patient with mrEMVI negative tumours post chemoradiotherapy. One pre-surgery and one during surgery from a peripheral vein.;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine if there is a link between EMVI status and ctDNA | 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. | Up to 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To investigate whether ctDNA levels change during surgery according to EMVI status | Measure the intraoperative % mutation frequency of ctDNA in EMVI positive compared with EMVI negative patients | Up to 2 years | 
| To investigate the effect of ctDNA status on patient survival outcomes | Record survival outcomes of patients who are: EMVI negative with low ctDNA levels, EMVI negative with high ctDNA levels, EMVI positive with low ctDNA levels, EMVI positive with high ctDNA levels | At 1, 2 and 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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EMVI, Extramural Venous Invasion, mrEMVI, Rectal Cancer, ctDNA, Neoplasm DNA, MRI