Circulating Tumour DNA (ctDNA) in Patients With Colorectal Cancer and the Relationship to Imaging Features of Extramural Venous Invasion
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Blood sample (mrEMVI positive patient), Blood sample (mrEMVI negative patient).
- Who it may be relevant to
- Registry conditions: Cancer, Rectal Cancer. Basic parameters: from 16 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United Kingdom
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
Interventions
- Other 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. - Other Blood sample (mrEMVI negative patient)
Primary outcome measures
- To determine if there is a link between EMVI status and ctDNA [Time frame: Up to 2 years]
Secondary outcome measures (2)
- To investigate whether ctDNA levels change during surgery according to EMVI status [Time frame: Up to 2 years]
- To investigate the effect of ctDNA status on patient survival outcomes [Time frame: At 1, 2 and 3 years]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United Kingdom · 3 centers
- Queen Elizabeth the Queen Mother Hospital — Margate
- St Mary's Hospital (Imperial) — Hammersmith
- Royal Marsden Hospital NHS Foundation Trust — Sutton
Identifiers
NCT: NCT02579278 · DOCUMAS: 23HH8182