CancerctDNANCT02579278
Circulating Tumour DNA (ctDNA) in Patients With Colorectal Cancer and the Relationship to Imaging Features of Extramural Venous Invasion
An observational study of Cancer and Rectal Cancer, run by Imperial College London at 3 sites in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Cancer, Rectal Cancer
- What is being tested?
- Blood sample (mrEMVI positive patient) and Blood sample (mrEMVI negative patient)
- How many people
- 100 participants
- Where
- 3 sitesUnited Kingdom
- Study dates
- Nov 2015to Dec 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- Have metastatic disease (including resectable liver metastases)
- Have a synchronous second malignancy
- Are contraindicated for any imaging able to determine EMVI status
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom3 sites, 3 recruiting
- Recruiting
St Mary's Hospital (Imperial)
Hammersmith, London, W2 1NY
Afeez Adebesin, afeez.adebesin@nhs.net
James Kinross
- Recruiting
Queen Elizabeth the Queen Mother Hospital
Margate, Kent, CT9 4AN
Sharon Turney, sharon.turney@nhs.net
Jess Evans
- Recruiting
Royal Marsden Hospital NHS Foundation Trust
Sutton, Surrey, SM2 5PT
Cordelia Grant, cordelia.grant@rmh.nhs.uk
Christos Kontovounisios, MD
About this study
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.
Read the 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
- Conditions
- Cancer, Rectal Cancer
- Being tested
- Blood sample (mrEMVI positive patient), Blood sample (mrEMVI negative patient)
- Keywords
- EMVI, Extramural Venous Invasion, mrEMVI, Rectal Cancer, ctDNA, Neoplasm DNA, MRI
- Medical subject headings
- Neoplasms, Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
Also called 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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Other: Blood sample (mrEMVI positive patient) | |
| mrEMVI negative rectal tumours | Patients registered who were mrEMVI positive at baseline MRI but have become mrEMVI negative post-chemoradiotherapy. Receives: Other: Blood sample (mrEMVI negative patient) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 2 years
Secondary outcomes (2)
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
Measured: Up to 2 years
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
Measured: At 1, 2 and 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2015 (estimated)
- Study startNov 2015
- Primary completionDec 2026 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gina Brown, MD, Principal investigator, Imperial College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02579278
- Sponsor's protocol ID
- DOCUMAS: 23HH8182
- Acronym
- ctDNA
- Status last verified
- Oct 2024
- First submitted
- 6 Oct 2015
- Last updated
- 17 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Circulating Tumour DNA (ctDNA) in Patients With Colorectal Cancer and the Relationship to Imaging Features of Extramural Venous Invasion
- ClinicalTrials.gov ID
- NCT02579278
- Acronym / sponsor ID
- ctDNA / DOCUMAS: 23HH8182
- Conditions
- Cancer, Rectal Cancer
- Keywords
- EMVI, Extramural Venous Invasion, mrEMVI, Rectal Cancer, ctDNA, Neoplasm DNA, MRI
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Study start
- Nov 2015 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 19 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| mrEMVI positive rectal tumours | – | Other: Blood sample (mrEMVI positive patient)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 | – | Other: Blood sample (mrEMVI negative patient)Patients registered who were mrEMVI positive at baseline MRI but have become mrEMVI negative post-chemoradiotherapy. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- Have metastatic disease (including resectable liver metastases)
- Have a synchronous second malignancy
- Are contraindicated for any imaging able to determine EMVI status
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | mrEMVI positive rectal tumours |
| Blood sample (mrEMVI negative patient)Also: 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. | Other | mrEMVI negative rectal tumours |
Primary outcome
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.
2 secondary outcomes
To investigate whether ctDNA levels change during surgery according to EMVI status
Time frame: Up to 2 years
To investigate the effect of ctDNA status on patient survival outcomes
Time frame: At 1, 2 and 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Gina Brown, MD principal investigator
Imperial College London
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer and Rectal Cancer, run by Imperial College London at 3 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Caroline Martin (+44 (0) 7749 655 817, c.martin1@imperial.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine if there is a link between EMVI status and ctDNA (time frame: Up to 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2024.