Cancer, Rectal Cancer
Conditions
Keywords
EMVI, Extramural Venous Invasion, mrEMVI, Rectal Cancer, ctDNA, Neoplasm DNA, MRI
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
Interventions
OTHERBlood 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.
OTHERBlood sample (mrEMVI negative patient)
Sponsors
Imperial College London
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United Kingdom
Contacts
Primary ContactCaroline Martin
Backup ContactSyvella Ellis
Outcome results
None listed