Molecular, Pathologic and MRI Investigation of the Prognostic and Redictive Importance of Extramural Venous Invasion in Rectal Cancer (MARVEL) Trial
Conditions
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
Conditions: official terms
Adenocarcinoma - Adenocarcinoma, Mucinous - Colorectal Neoplasms - Digestive System Diseases - Digestive System Neoplasms - Gastrointestinal Diseases - Gastrointestinal Neoplasms - Intestinal Diseases - Intestinal Neoplasms - Neoplasms - Neoplasms by Histologic Type - Neoplasms by Site - Neoplasms, Glandular and Epithelial - Rectal Diseases
Conditions: Keywords
Rectal Cancer, EMVI, Extramural Venous Invasion, Microarray, Biomarker, mrEMVI, Tumour Regression Grade, Cancer, Circumferential Resection Margin, CRM, MRI, Radiology, Surgery, Pathology
Study Type
Observational
Study Phase
N/A
Study Design
Observational Model: Cohort, Time Perspective: Prospective
Overall Status
Recruiting
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.
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).
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: 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)
Locations
University Hospital Southampton NHS Foundation Trust
Southampton, Hampshire, United Kingdom
Status: Recruiting
Contact: Andrea Lodge - A.Lodge@soton.ac.uk
Homerton University Hospital
London, Surrey, United Kingdom
Status: Not yet recruiting
Contact: Eleni Ntala - eleni.ntala@homerton.nhs.uk
Croydon University Hospital
Thornton Heath, Surrey, United Kingdom
Status: Not yet recruiting
Contact: Yvonne Campbell - Yvonne.Campbell@croydonhealth.nhs.uk
University Hospital Coventry
Coventry, West Midlands, United Kingdom
Status: Not yet recruiting
Contact: Maggie Brown - Maggie.Brown@uhcw.nhs.uk
Salisbury District Hospital
Salisbury, Wiltshire, United Kingdom
Status: Not yet recruiting
Contact: Julie Atlee - julie.atlee@salisbury.nhs.uk
Royal Marsden Hospital
London and Surrey, United Kingdom
Status: Not yet recruiting
Contact: Lisa Scerri - 0208 915 6067 - lisa.scerri@gmail.com
George Eliot Hospital
Nuneaton, United Kingdom
Status: Not yet recruiting
Contact: Maggie Brown - maggie.brown@uhcw.nhs.uk
Alexandra Hospital
Redditch, United Kingdom
Status: Not yet recruiting
Contact: Maggie Brown - maggie.brown@uhcw.nhs.uk
South Warwickshire NHS Foundation Trust (Warwick Hospital)
Warwick, United Kingdom
Status: Not yet recruiting
Contact: Maggie Brown - maggie.brown@uhcw.nhs.uk
Start Date
June 2013
Completion Date
June 2018
Sponsors
Royal Marsden NHS Foundation Trust
Source
Royal Marsden NHS Foundation Trust
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page