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

October 16, 2024 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

Study Contact Backup

Study Locations

  • United Kingdom
    • Kent
      • Margate, Kent, United Kingdom, CT9 4AN
        • Recruiting
        • Queen Elizabeth the Queen Mother Hospital
        • Contact:
        • Principal Investigator:
          • Jess Evans
    • London
      • Hammersmith, London, United Kingdom, W2 1NY
        • Recruiting
        • St Mary's Hospital (Imperial)
        • Contact:
        • Principal Investigator:
          • James Kinross
    • Surrey
      • Sutton, Surrey, United Kingdom, SM2 5PT
        • Recruiting
        • Royal Marsden Hospital NHS Foundation Trust
        • Contact:
        • 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

14 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:

  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

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).
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.
mrEMVI negative rectal tumours
Patients registered who were mrEMVI positive at baseline MRI but have become mrEMVI negative post-chemoradiotherapy.
Other: Blood sample (mrEMVI negative patient)
Other Names:
  • 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.

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

Imperial College London

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 (Actual)

November 1, 2015

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2029

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)

October 17, 2024

Last Update Submitted That Met QC Criteria

October 16, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

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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