- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01995942
Molecular, Pathologic and MRI Investigation of the Prognostic and Redictive Importance of Extramural Venous Invasion in Rectal Cancer (MARVEL) Trial (MARVEL)
Molecular, Pathologic and MRI Investigation of the Prognostic and Redictive Importance of Extramural Venous Invasion in Rectal Cancer
Study Overview
Status
Conditions
- Digestive System Diseases
- Gastrointestinal Diseases
- Neoplasms
- Neoplasms by Histologic Type
- Neoplasms by Site
- Adenocarcinoma
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Intestinal Diseases
- Colorectal Neoplasms
- Intestinal Neoplasms
- Rectal Diseases
- Neoplasms, Cystic, Mucinous, and Serous
- Adenocarcinoma, Mucinous
Detailed Description
Neoadjuvant chemoradiotherapy (CRT) is widely accepted as beneficial to selected patients in terms of decreased risk of local recurrence and overall survival. Current management of rectal cancer involves risk stratification through pre-operative staging leading to formulation of treatment strategy. Very little is known about the long-term outcomes and response to CRT on MRI detected extramural venous invasion (mrEMVI). Although mrEMVI is accepted as a marker of poor prognosis, whether it has a predictive value and should be specifically treated is not known.
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).
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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London And Surrey, United Kingdom
- Royal Marsden Hospital
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Nuneaton, United Kingdom, CV10 7DJ
- George Eliot Hospital
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Redditch, United Kingdom, B98 7UB
- Alexandra Hospital
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Warwick, United Kingdom, CV34 5BW
- South Warwickshire NHS Foundation Trust (Warwick Hospital)
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Cambridgeshire
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Peterborough, Cambridgeshire, United Kingdom, PE3 9GZ
- Peterborough City Hospital
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Cheshire
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Crewe, Cheshire, United Kingdom, CW1 4QJ
- Leighton Hospital
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Cornwall
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Truro, Cornwall, United Kingdom, TR1 3LQ
- Royal Cornwall Hospital
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Devon
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Plymouth, Devon, United Kingdom, PL6 8DH
- Derriford Hospital
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Dorset
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Poole, Dorset, United Kingdom, BH15 2JB
- Poole Hospital
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Hampshire
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Southampton, Hampshire, United Kingdom, SO16 6YD
- University Hospital Southampton NHS Foundation Trust
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Manchester
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Crumpsall, Manchester, United Kingdom, M8 5RB
- North Manchester General Hospital
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Wythenshawe, Manchester, United Kingdom, M23 9LT
- University Hospital of South Manchester
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Nottinghamshire
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Sutton-in-Ashfield, Nottinghamshire, United Kingdom, NG17 4JL
- Kings Mill Hospital
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Staffordshire
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Burton-on-Trent, Staffordshire, United Kingdom, Burton-on-Trent
- Queen's Hospital, Burton Upon Trent
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Surrey
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Guildford, Surrey, United Kingdom, GU2 7XX
- Royal Surrey County Hospital
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London, Surrey, United Kingdom, E9 6SR
- Homerton University Hospital
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Thornton Heath, Surrey, United Kingdom, CR7 7YE
- Croydon University Hospital
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West Midlands
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Coventry, West Midlands, United Kingdom, CV2 2DX
- University Hospital Coventry
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Wiltshire
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Salisbury, Wiltshire, United Kingdom, SP2 8BJ
- Salisbury District Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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
Exclusion Criteria
- Metastatic disease at presentation
- Emergency diagnosis/treatment
- Unable to undergo staging (MRI and CT) or treatment procedures (LCRT/surgery)
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
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Group 1
Patients with mrEMVI positive rectal cancer
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Group 2
Patients with mrEMVI negative rectal cancer
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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The primary endpoint will be time to relapse pertaining to the primary objective of relapse rate at 1 year and 3 years.
Time Frame: 3 years
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3 years
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
Time Frame: 3 years
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3 years
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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).
Time Frame: 5 months
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mrEMVI Regression Grade Scoring Table: Grade 5 - No response (intermediate signal intensity, same appearances as original tumour) Grade 4 - Slight response (little areas of fibrosis or mucin but mostly tumour) Grade 3 - Moderate response (>50% fibrosis or mucin, and visible intermediate signal) Grade 2 - Good response (dense fibrosis; no obvious residual tumour, signifying minimal residual disease or no tumour) Grade 1 - Radiological complete response (rCR) (linear/crescentic 1-2mm scar in mucosa or submucosa only.)
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5 months
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Gina Brown, Royal Marsden NHS Foundation Trust
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Carcinoma
- Colonic Diseases
- Neoplasms
- Colorectal Neoplasms
- Adenocarcinoma
- Rectal Neoplasms
- Gastrointestinal Diseases
- Digestive System Diseases
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Intestinal Diseases
- Adenocarcinoma, Mucinous
- Intestinal Neoplasms
- Neoplasms, Glandular and Epithelial
- Neoplasms by Site
- Neoplasms by Histologic Type
- Rectal Diseases
- Neoplasms, Cystic, Mucinous, and Serous
Other Study ID Numbers
- CCR3873
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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