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

Cancer Clinical Trial

— ctDNA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02579278
• Other study ID #: DOCUMAS: 23HH8182
• Status: Recruiting
• Start date: November 2015
• Est. completion date: December 2027

Study information

• Verified date: August 2023
• Source: Imperial College London
• Contact: Caroline Martin
• Phone: +44 (0) 7749 655 817
• Email: c.martin1[@]imperial.ac.uk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2027
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer
• Rectal Cancer
• Rectal Neoplasms

Intervention

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.
• Blood sample (mrEMVI negative patient)

Locations

Country	Name	City	State
United Kingdom	St Mary's Hospital (Imperial)	Hammersmith	London
United Kingdom	Queen Elizabeth the Queen Mother Hospital	Margate	Kent
United Kingdom	Royal Marsden Hospital NHS Foundation Trust	Sutton	Surrey

Sponsors (1)

Lead Sponsor	Collaborator
Imperial College London

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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
Secondary	To investigate the effect of ctDNA status on patient survival outcomes	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