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

Imperial College London

Status: Enrolling

Conditions: Cancer; Rectal Cancer

Treatments: Other: Blood sample (mrEMVI negative patient); Other: Blood sample (mrEMVI positive patient)

Study type: Observational

Funder types: Other

Identifiers

NCT02579278

DOCUMAS: 23HH8182

Details and patient eligibility

About

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.

Full 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

Enrollment: 100 estimated patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

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

Trial design

100 participants in 2 patient groups

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).

Treatment:

Other: Blood sample (mrEMVI positive patient)

mrEMVI negative rectal tumours

Description:

Patients registered who were mrEMVI positive at baseline MRI but have become mrEMVI negative post-chemoradiotherapy.

Treatment:

Other: Blood sample (mrEMVI negative patient)