Molecular, Pathologic and MRI Investigation of the Prognostic and Redictive Importance of Extramural Venous Invasion in Rectal Cancer (MARVEL) Trial
NCT ID: NCT01995942
Last Updated: 2018-09-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
246 participants
OBSERVATIONAL
2013-06-07
2022-02-02
Brief Summary
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Detailed Description
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Molecular and genetic profiling provides us with an opportunity to understand the underlying mechanisms which govern clinical behaviour in rectal cancer. Using high-throughput technology such as tissue microarray analysis allows large-scale analysis of specimens in a relatively short amount of time. It offers the ability to compare the molecular profiles of different subtypes of rectal cancer such as mrEMVI-positive and -negative tumours and whether any changes are observed following CRT. This can then be correlated with clinical behaviour over the medium and long-term with regards to local recurrence, distant metastases and overall survival.
This study will identify important differences between key rectal cancer tumour subtypes. Identification of reliable pathological markers of EMVI pathways (from both the primary tumour sample, but more importantly from the pre-operative biopsies) has real potential for taking us a step closer to more personalised management of rectal cancer by establishing prognostic biomarkers reflective of disease type, but also through the underlying biology that may be highlighted (with its promise of therapeutic translation).
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Group 1
Patients with mrEMVI positive rectal cancer
No interventions assigned to this group
Group 2
Patients with mrEMVI negative rectal cancer
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
2. Adult patients - over 18 years
3. Able to undergo curative (TME) surgery
4. Able to undergo MRI and CT with relevant contrast agent
5. Able to undergo LCRT
Exclusion Criteria
2. Emergency diagnosis/treatment
3. Unable to undergo staging (MRI and CT) or treatment procedures (LCRT/surgery)
18 Years
ALL
No
Sponsors
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Pelican Cancer Foundation
OTHER
Royal Marsden NHS Foundation Trust
OTHER
Responsible Party
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Principal Investigators
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Gina Brown
Role: PRINCIPAL_INVESTIGATOR
Royal Marsden NHS Foundation Trust
Locations
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Peterborough City Hospital
Peterborough, Cambridgeshire, United Kingdom
Leighton Hospital
Crewe, Cheshire, United Kingdom
Royal Cornwall Hospital
Truro, Cornwall, United Kingdom
Derriford Hospital
Plymouth, Devon, United Kingdom
Poole Hospital
Poole, Dorset, United Kingdom
University Hospital Southampton NHS Foundation Trust
Southampton, Hampshire, United Kingdom
North Manchester General Hospital
Crumpsall, Manchester, United Kingdom
University Hospital of South Manchester
Wythenshawe, Manchester, United Kingdom
Kings Mill Hospital
Sutton in Ashfield, Nottinghamshire, United Kingdom
Queen's Hospital, Burton Upon Trent
Burton-on-Trent, Staffordshire, United Kingdom
Royal Surrey County Hospital
Guildford, Surrey, United Kingdom
Homerton University Hospital
London, Surrey, United Kingdom
Croydon University Hospital
Thornton Heath, Surrey, United Kingdom
University Hospital Coventry
Coventry, West Midlands, United Kingdom
Salisbury District Hospital
Salisbury, Wiltshire, United Kingdom
Royal Marsden Hospital
London and Surrey, , United Kingdom
George Eliot Hospital
Nuneaton, , United Kingdom
Alexandra Hospital
Redditch, , United Kingdom
South Warwickshire NHS Foundation Trust (Warwick Hospital)
Warwick, , United Kingdom
Countries
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Other Identifiers
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CCR3873
Identifier Type: -
Identifier Source: org_study_id
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