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

Recruiting

• Conditions: Cancer; Rectal Cancer
• Interventions: Other: Blood sample (mrEMVI positive patient); Other: Blood sample (mrEMVI negative patient)

• Registration Number: NCT02579278
• Lead Sponsor: Imperial College London

Brief Summary

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

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

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2015-10-06
• Study First Submitted QC: 2015-10-16
• Study First Posted: 2015-10-19
• Study Start: 2015-11
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-16
• Last Update Posted: 2024-10-17
• Primary Completion: 2026-12
• Study Completion: 2029-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
mrEMVI positive rectal tumours	Blood sample (mrEMVI positive patient)	Patients will be registered whose rectal tumours are mrEMVI positive (i.e. EMVI is present in baseline and post-chemoradiotherapy MRI scans).
mrEMVI negative rectal tumours	Blood sample (mrEMVI negative patient)	Patients registered who were mrEMVI positive at baseline MRI but have become mrEMVI negative post-chemoradiotherapy.

Primary Outcome Measures

Name	Time	Method
To determine if there is a link between EMVI status and ctDNA	Up to 2 years	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.

Secondary Outcome Measures

Name	Time	Method
To investigate the effect of ctDNA status on patient survival outcomes	At 1, 2 and 3 years	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
To investigate whether ctDNA levels change during surgery according to EMVI status	Up to 2 years	Measure the intraoperative % mutation frequency of ctDNA in EMVI positive compared with EMVI negative patients

Trial Locations

Locations (3)

Queen Elizabeth the Queen Mother Hospital; 🇬🇧 Margate, Kent, United Kingdom

St Mary's Hospital (Imperial); 🇬🇧 Hammersmith, London, United Kingdom

Royal Marsden Hospital NHS Foundation Trust; 🇬🇧 Sutton, Surrey, United Kingdom