Molecular, Pathologic and MRI Investigation of the Prognostic and Redictive Importance of Extramural Venous Invasion in Rectal Cancer (MARVEL) Trial
MARVEL
1 other identifier
observational
246
1 country
19
Brief Summary
Extramural venous invasion (EMVI) is the spread of microscopic tumour cells into the veins around the tumour. Rectal cancer treatment has improved greatly over recent years. However, it is important for us to learn as much about the tumours as possible in order to develop newer therapies. Current treatments may benefit from new genetic information relating to the cancer. We hope to identify genetic differences in certain types of rectal cancer which will allow future treatments.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2013
Longer than P75 for all trials
19 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 7, 2013
CompletedFirst Submitted
Initial submission to the registry
November 21, 2013
CompletedFirst Posted
Study publicly available on registry
November 27, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 2, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
February 2, 2022
CompletedSeptember 14, 2018
September 1, 2018
3.7 years
November 21, 2013
September 13, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The primary endpoint will be time to relapse pertaining to the primary objective of relapse rate at 1 year and 3 years.
3 years
Secondary Outcomes (2)
Response rates (in terms of mrTstage, mrN stage, involvement of CRM (circumferential resection margin) and mrTRG (tumour regression grade)) in addition to recurrence rates at 1 year and 3 years.
3 years
Measurement of the change in mrEMVI from pre to post pre-operative therapy, will be based on a new proposed EMVI-TRG classification (EMVI TRG 1-5).
5 months
Study Arms (2)
Group 1
Patients with mrEMVI positive rectal cancer
Group 2
Patients with mrEMVI negative rectal cancer
Eligibility Criteria
Patients aged over 18 years of age presenting with adenocarcinoma of the rectum. This will be diagnosed on colonoscopy and/or biopsy and MRI, and treatment strategy will include pre-operative CRT followed by surgery.
You may qualify if:
- Locally advanced primary rectal cancer (requiring pre-operative treatment); diagnosed on tissue biopsy
- Adult patients - over 18 years
- Able to undergo curative (TME) surgery
- Able to undergo MRI and CT with relevant contrast agent
- Able to undergo LCRT
You may not qualify if:
- Metastatic disease at presentation
- Emergency diagnosis/treatment
- Unable to undergo staging (MRI and CT) or treatment procedures (LCRT/surgery)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Royal Marsden NHS Foundation Trustlead
- Pelican Cancer Foundationcollaborator
Study Sites (19)
Peterborough City Hospital
Peterborough, Cambridgeshire, PE3 9GZ, United Kingdom
Leighton Hospital
Crewe, Cheshire, CW1 4QJ, United Kingdom
Royal Cornwall Hospital
Truro, Cornwall, TR1 3LQ, United Kingdom
Derriford Hospital
Plymouth, Devon, PL6 8DH, United Kingdom
Poole Hospital
Poole, Dorset, BH15 2JB, United Kingdom
University Hospital Southampton NHS Foundation Trust
Southampton, Hampshire, SO16 6YD, United Kingdom
North Manchester General Hospital
Crumpsall, Manchester, M8 5RB, United Kingdom
University Hospital of South Manchester
Wythenshawe, Manchester, M23 9LT, United Kingdom
Kings Mill Hospital
Sutton in Ashfield, Nottinghamshire, NG17 4JL, United Kingdom
Queen's Hospital, Burton Upon Trent
Burton-on-Trent, Staffordshire, Burton-on-Trent, United Kingdom
Royal Surrey County Hospital
Guildford, Surrey, GU2 7XX, United Kingdom
Homerton University Hospital
London, Surrey, E9 6SR, United Kingdom
Croydon University Hospital
Thornton Heath, Surrey, CR7 7YE, United Kingdom
University Hospital Coventry
Coventry, West Midlands, CV2 2DX, United Kingdom
Salisbury District Hospital
Salisbury, Wiltshire, SP2 8BJ, United Kingdom
Royal Marsden Hospital
London and Surrey, United Kingdom
George Eliot Hospital
Nuneaton, CV10 7DJ, United Kingdom
Alexandra Hospital
Redditch, B98 7UB, United Kingdom
South Warwickshire NHS Foundation Trust (Warwick Hospital)
Warwick, CV34 5BW, United Kingdom
Biospecimen
Histopathology samples taken after rectal tumour removal surgery will be analysed using micrarray techniques. The pathological tissue microarrays (TMAs) will be generated using the Alphelys Tissue Arrayer Minicore®3 system. Markers that will be evaluated will be initially directed at epithelial to mesenchymal (EMT) transition pathways, as our preliminary studies suggest that this phylogenetically conserved molecular program has important roles in tumour dissemination and resistance to conventional chemotherapy.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Gina Brown
Royal Marsden NHS Foundation Trust
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 21, 2013
First Posted
November 27, 2013
Study Start
June 7, 2013
Primary Completion
February 2, 2017
Study Completion
February 2, 2022
Last Updated
September 14, 2018
Record last verified: 2018-09