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

Results pending

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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Recruitment Status

UNKNOWN

Total Enrollment

246 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-06-07

Study Completion Date

2022-02-02

Brief Summary

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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.

Detailed Description

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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).

Conditions

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Adenocarcinoma Rectal Diseases Colorectal Neoplasms Adenocarcinoma, Mucinous Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Neoplasms, Cystic, Mucinous, and Serous Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases

Study Design

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Observational Model Type

COHORT

Study Time Perspective

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

1. Locally advanced primary rectal cancer (requiring pre-operative treatment); diagnosed on tissue biopsy
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

1. Metastatic disease at presentation
2. Emergency diagnosis/treatment
3. Unable to undergo staging (MRI and CT) or treatment procedures (LCRT/surgery)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pelican Cancer Foundation

OTHER

Sponsor Role collaborator

Royal Marsden NHS Foundation Trust

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

Leighton Hospital

Crewe, Cheshire, United Kingdom

Site Status

Royal Cornwall Hospital

Truro, Cornwall, United Kingdom

Site Status

Derriford Hospital

Plymouth, Devon, United Kingdom

Site Status

Poole Hospital

Poole, Dorset, United Kingdom

Site Status

University Hospital Southampton NHS Foundation Trust

Southampton, Hampshire, United Kingdom

Site Status

North Manchester General Hospital

Crumpsall, Manchester, United Kingdom

Site Status

University Hospital of South Manchester

Wythenshawe, Manchester, United Kingdom

Site Status

Kings Mill Hospital

Sutton in Ashfield, Nottinghamshire, United Kingdom

Site Status

Queen's Hospital, Burton Upon Trent

Burton-on-Trent, Staffordshire, United Kingdom

Site Status

Royal Surrey County Hospital

Guildford, Surrey, United Kingdom

Site Status

Homerton University Hospital

London, Surrey, United Kingdom

Site Status

Croydon University Hospital

Thornton Heath, Surrey, United Kingdom

Site Status

University Hospital Coventry

Coventry, West Midlands, United Kingdom

Site Status

Salisbury District Hospital

Salisbury, Wiltshire, United Kingdom

Site Status

Royal Marsden Hospital

London and Surrey, , United Kingdom

Site Status

George Eliot Hospital

Nuneaton, , United Kingdom

Site Status

Alexandra Hospital

Redditch, , United Kingdom

Site Status

South Warwickshire NHS Foundation Trust (Warwick Hospital)

Warwick, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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CCR3873

Identifier Type: -

Identifier Source: org_study_id

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