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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-11-30

Study Completion Date

2029-12-31

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.

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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

Conditions

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Cancer Rectal Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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mrEMVI positive rectal tumours

Patients will be registered whose rectal tumours are mrEMVI positive (i.e. EMVI is present in baseline and post-chemoradiotherapy MRI scans).

Blood sample (mrEMVI positive patient)

Intervention Type OTHER

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.

mrEMVI negative rectal tumours

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

Blood sample (mrEMVI negative patient)

Intervention Type OTHER

Interventions

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Blood sample (mrEMVI positive patient)

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.

Intervention Type OTHER

Blood sample (mrEMVI negative patient)

Intervention Type OTHER

Other Intervention Names

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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.

Eligibility Criteria

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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

Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No