- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02579278
Circulating Tumour DNA (ctDNA) in Patients With Colorectal Cancer and the Relationship to Imaging Features of Extramural Venous Invasion (ctDNA)
August 30, 2023 updated by: Imperial College London
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
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
Study Type
Observational
Enrollment (Estimated)
100
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Caroline Martin
- Phone Number: +44 (0) 7749 655 817
- Email: c.martin1@imperial.ac.uk
Study Contact Backup
- Name: Syvella Ellis
- Phone Number: +44 (0) 7732 315 234
- Email: giclinicaltrials@imperial.ac.uk
Study Locations
-
-
Kent
-
Margate, Kent, United Kingdom, CT9 4AN
- Recruiting
- Queen Elizabeth the Queen Mother Hospital
-
Contact:
- Sharon Turney
- Email: sharon.turney@nhs.net
-
Principal Investigator:
- Jess Evans
-
-
London
-
Hammersmith, London, United Kingdom, W2 1NY
- Recruiting
- St Mary's Hospital (Imperial)
-
Contact:
- Afeez Adebesin
- Email: afeez.adebesin@nhs.net
-
Principal Investigator:
- James Kinross
-
-
Surrey
-
Sutton, Surrey, United Kingdom, SM2 5PT
- Recruiting
- Royal Marsden Hospital NHS Foundation Trust
-
Contact:
- Cordelia Grant
- Email: cordelia.grant@rmh.nhs.uk
-
Principal Investigator:
- Christos Kontovounisios, MD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
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
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
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).
|
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.
|
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
To determine if there is a link between EMVI status and ctDNA
Time Frame: 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.
|
Up to 2 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
To investigate whether ctDNA levels change during surgery according to EMVI status
Time Frame: Up to 2 years
|
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
Time Frame: 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
|
At 1, 2 and 3 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Gina Brown, MD, Imperial College London
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2015
Primary Completion (Estimated)
December 1, 2024
Study Completion (Estimated)
December 1, 2027
Study Registration Dates
First Submitted
October 6, 2015
First Submitted That Met QC Criteria
October 16, 2015
First Posted (Estimated)
October 19, 2015
Study Record Updates
Last Update Posted (Actual)
September 5, 2023
Last Update Submitted That Met QC Criteria
August 30, 2023
Last Verified
August 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DOCUMAS: 23HH8182
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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