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NCT Number: NCT02579278

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

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.

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Key information

Conditions

Cancer Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Cancer Rectal Diseases Rectal Neoplasms

Age range

16 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Queen Elizabeth the Queen Mother Hospital, Margate, Kent, United Kingdom

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Blood sample (mrEMVI negative patient)

Other

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

  2. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Caroline Martin

CONTACT

[email protected]

+44 (0) 7749 655 817

Syvella Ellis

CONTACT

[email protected]

+44 (0) 7732 315 234

Sponsors and collaborators

Lead sponsor

Imperial College London

Other

Registry information

Acronym: ctDNA

Important dates

Study start
2015
Primary completion
2026
Study completion
2029
First posted
Oct 19, 2015
Registry last updated
Oct 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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