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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
| |
| mrEMVI negative rectal tumours | Patients registered who were mrEMVI positive at baseline MRI but have become mrEMVI negative post-chemoradiotherapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood sample (mrEMVI positive patient) | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| To determine if there is a link between EMVI status and ctDNA | 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. | Up to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| To investigate whether ctDNA levels change during surgery according to EMVI status | Measure the intraoperative % mutation frequency of ctDNA in EMVI positive compared with EMVI negative patients | Up to 2 years |
| To investigate the effect of ctDNA status on patient survival outcomes |
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Inclusion Criteria:
Exclusion Criteria:
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100 adult patients presenting with primary colorectal cancer proven on biopsy with no evidence of metastatic disease on CT and who are eligible for curative surgery
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Caroline Martin | Contact | +44 (0) 7749 655 817 | c.martin1@imperial.ac.uk | |
| Syvella Ellis | Contact | +44 (0) 7732 315 234 | giclinicaltrials@imperial.ac.uk |
| Name | Affiliation | Role |
|---|---|---|
| Gina Brown, MD | Imperial College London | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Queen Elizabeth the Queen Mother Hospital | Recruiting | Margate | Kent | CT9 4AN | United Kingdom |
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Each patient will have two blood samples taken that will be analysed for ctDNA. One blood sample will be taken at the time of preoperative assessment, after chemoradiotherapy, and a further sample will be taken intraoperatively, from the peripheral vein of the patient's arm. For each of the blood samples the presence or absence of ctDNA mutations (kras and p53) will be identified.
| Blood sample (mrEMVI negative patient) | Other |
|
|
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 |
| At 1, 2 and 3 years |
| St Mary's Hospital (Imperial) | Recruiting | Hammersmith | London | W2 1NY | United Kingdom |
|
| Royal Marsden Hospital NHS Foundation Trust | Recruiting | Sutton | Surrey | SM2 5PT | United Kingdom |
|
| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D012004 | Rectal Neoplasms |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
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