Colo-rectal CancerEVIDENCENCT06646341
EMVI as a Determinant of Metastasis in Colorectal Cancer
An observational study of Colo-rectal Cancer, run by Imperial College London at 1 site in United Kingdom.
Trial summary
Bowel cancer is the fourth most commonly occurring cancer and the second highest cause of cancer deaths in the UK. Despite advances in treatment, over 40% of patients will die within 5 years. This is normally due to spread of the cancer to other organs (called metastases). Read more about this study
- Who is it for?
- Ages 16 to 100 years
- Conditions the study is for
- Colo-rectal Cancer
- How many people
- 100 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Jan 2023to 31 Dec 2027
- 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 to 100 years
- All sexes
- Child, Adult, Older adult
Study population: Patients who have undergone a primary resection of their colon or rectum as well as a resection of a distant metastases
Who may be able to join
- Are aged 16 years or over with colorectal cancer
- Colon / rectum has been surgically removed
- Distant metastases has been surgically removed
- Pre operative staging in the form of CT/MRI has been undertaken and images available for review
Who cannot join
- Pathological complete response in the primary tumour
- Local resection of the primary tumour
- Inadequate quantity of tissue sample to perform analyses
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
Hampshire Hospitals Nhs Foundation Trust
Basingstoke, Hampshire, RG24 9NA
Amy Lord, MD, 0784150064, amylord@nhs.net
About this study
Bowel cancer is the fourth most commonly occurring cancer and the second highest cause of cancer deaths in the UK. Despite advances in treatment, over 40% of patients will die within 5 years. This is normally due to spread of the cancer to other organs (called metastases). Much of the current research focuses on use of additional treatments such as radiotherapy and chemotherapy before or after surgery (adjuvant treatment). It is of vital importance that patients who would benefit from adjuvant treatment can be accurately identified. At the moment, the system used locally to do this places emphasis on the presence of affected lymph nodes (glands). This is because doctors believe that cancer spreads to other organs through the lymphatic system. However, recent studies have suggested that this is not the case.
It is believed that cancer spreads to other organs through the blood stream rather than the lymph node system. This research will look at the genetic material in tumours and metastases as well as in areas of blood vessel invasion and lymph nodes. The analysis will allow us to build a 'family tree' of the tumour and allow us to map the pathway by which the tumour spreads. Tissue samples already collected through a patient's routine care will be used for this study. If the spread through the blood vessels is proven, this would change the way in which patients are selected for treatment and allow development of new treatments to target these pathways.
Read the detailed description
A retrospective ,non-interventional tissue study using archival materials collected through a patient's routine care, EVIDENCE aims to demonstrate that distant metastases in colorectal cancer are related to Extramural Venous Invasion (EMVI) and tumour deposits, not lymph nodes. As EVIDENCE is a retrospective study, there are no time dependent schedules for Case Report Form (CRF) completion or tissue submission.
It will be tested whether the vascular route of spread (as evidenced through EMVI and tumour deposits) is more important than lymph nodes in the development of metastatic disease. The sub-clonal origins of primary colorectal cancers, EMVI, tumour deposits, lymph nodes and distant metastases by reconstructing phylogenetic trees will be compared. A proof for a vascular route of spread rather than lymph nodes would lead to a paradigm shift in future decision making at national and international level.
- Conditions
- Colo-rectal Cancer
- Keywords
- Extramural Venous Invasion, Extranodal Tumour Deposits, Imaging and Pathology Biomarkers, Pelvic Recurrence, Colorectal Cancer, Local Advanced Rectal Cancer, Metastatic Spread, MRI staging, Phylogenesis, Rectal Cancer Recurrence, Sigmoid Cancer, Surgery for Pelvic Recurrence
- Medical subject headings
- Colonic Neoplasms, Colorectal Neoplasms, Sigmoid Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of proportion of subjects where Extramural Venous Invasion (EMVI) and tumour deposits vs lymph nodes are associated with distant metastases
Proportion of subjects where EMVI and tumour deposits rather than lymph nodes are associated with distant metastases. This is to determine the route of spread of distant metastases.
Measured: 1 year from last registered patient
Secondary outcomes (4)
Comparison of tumour phylogenetic profile between primary tumour, EMVI, tumour deposits, metastases
Comparison of tumour phylogenetic profile between primary tumour, EMVI, tumour deposits, metastases. This is to investigate the clonal origins of metastases in relation to the primary tumour deposits, EMVI and lymph nodes
Measured: 1 year from last registered patient
Comparison of tumour phylogenes between different metastatic sites and primary tumour
Comparison of tumour phylogenes between different metastatic sites and primary tumour. This is to determine if there are different routes of spread to different organs (i.e. lung, liver, brain, peritoneal)
Measured: 1 year from last registered patient
Comparison of immunohistochemistry staining profile between primary tumour, EMVI, tumour deposits, metastases
Comparison of immunohistochemistry staining profile between primary tumour, EMVI, tumour deposits, metastases. This is to evaluate the similarities in the immunohistochemistry profile of metastases compared with primary tumour deposits, EMVI and lymph nodes
Measured: 1 year from last registered patient
Comparison of overall survival based on clonal origins of metastases
Comparison of overall survival based on clonal origins of metastases. This is to investigate the relationship between the clonal origins of metastases and outcomes according to primary tumour deposits, EMVI and lymph nodes
Measured: 1 year from last registered patient
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2024
- Study start1 Jan 2023
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colo-rectal 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
- Case only
- Time perspective
- Retrospective
- 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
- NCT06646341
- Sponsor's protocol ID
- DOCUMAS: 22HH7583
- Acronym
- EVIDENCE
- Status last verified
- Oct 2024
- First submitted
- 15 Oct 2024
- Last updated
- 1 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EMVI as a Determinant of Metastasis in Colorectal Cancer
- ClinicalTrials.gov ID
- NCT06646341
- Acronym / sponsor ID
- EVIDENCE / DOCUMAS: 22HH7583
- Conditions
- Colo-rectal Cancer
- Keywords
- Extramural Venous Invasion, Extranodal Tumour Deposits, Imaging and Pathology Biomarkers, Pelvic Recurrence, Colorectal Cancer, Local Advanced Rectal Cancer, Metastatic Spread, MRI staging
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 17 Oct 2024 (actual)
- 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.
Bowel cancer is the fourth most commonly occurring cancer and the second highest cause of cancer deaths in the UK. Despite advances in treatment, over 40% of patients will die within 5 years. This is normally due to spread of the cancer to other organs (called metastases). Much of the current research focuses on use of additional treatments such as radiotherapy and chemotherapy before or after surgery (adjuvant treatment). It is of vital importance that patients who would benefit from adjuvant treatment can be accurately identified. At the moment, the system used locally to do this places emphasis on the presence of affected lymph nodes (glands). This is because doctors believe that cancer spreads to other organs through the lymphatic system. However, recent studies have suggested that this is not the case.
It is believed that cancer spreads to other organs through the blood stream rather than the lymph node system. This research will look at the genetic material in tumours and metastases as well as in areas of blood vessel invasion and lymph nodes. The analysis will allow us to build a 'family tree' of the tumour and allow us to map the pathway by which the tumour spreads. Tissue samples already collected through a patient's routine care will be used for this study. If the spread through the blood vessels is proven, this would change the way in which patients are selected for treatment and allow development of new treatments to target these pathways.
Detailed description
A retrospective ,non-interventional tissue study using archival materials collected through a patient's routine care, EVIDENCE aims to demonstrate that distant metastases in colorectal cancer are related to Extramural Venous Invasion (EMVI) and tumour deposits, not lymph nodes. As EVIDENCE is a retrospective study, there are no time dependent schedules for Case Report Form (CRF) completion or tissue submission.
It will be tested whether the vascular route of spread (as evidenced through EMVI and tumour deposits) is more important than lymph nodes in the development of metastatic disease. The sub-clonal origins of primary colorectal cancers, EMVI, tumour deposits, lymph nodes and distant metastases by reconstructing phylogenetic trees will be compared. A proof for a vascular route of spread rather than lymph nodes would lead to a paradigm shift in future decision making at national and international level.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 16 to 100 years
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Patients who have undergone a primary resection of their colon or rectum as well as a resection of a distant metastases
Key inclusion criteria (4 listed)
- Are aged 16 years or over with colorectal cancer
- Colon / rectum has been surgically removed
- Distant metastases has been surgically removed
- Pre operative staging in the form of CT/MRI has been undertaken and images available for review
Key exclusion criteria (3 listed)
- Pathological complete response in the primary tumour
- Local resection of the primary tumour
- Inadequate quantity of tissue sample to perform analyses
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Comparison of proportion of subjects where Extramural Venous Invasion (EMVI) and tumour deposits vs lymph nodes are associated with distant metastases
Time frame: 1 year from last registered patient
Proportion of subjects where EMVI and tumour deposits rather than lymph nodes are associated with distant metastases. This is to determine the route of spread of distant metastases.
4 secondary outcomes
Comparison of tumour phylogenetic profile between primary tumour, EMVI, tumour deposits, metastases
Time frame: 1 year from last registered patient
Comparison of tumour phylogenes between different metastatic sites and primary tumour
Time frame: 1 year from last registered patient
Comparison of immunohistochemistry staining profile between primary tumour, EMVI, tumour deposits, metastases
Time frame: 1 year from last registered patient
Comparison of overall survival based on clonal origins of metastases
Time frame: 1 year from last registered patient
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 1 Nov 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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colo-rectal Cancer, run by Imperial College London at 1 site 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 4 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 1 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Comparison of proportion of subjects where Extramural Venous Invasion (EMVI) and tumour deposits vs lymph nodes are associated with distant metastases (time frame: 1 year from last registered patient). 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 1 Nov 2024.