Trial Title:
Molecular, Pathologic and MRI Investigation of the Prognostic and Redictive Importance of Extramural Venous Invasion in Rectal Cancer (MARVEL) Trial
NCT ID:
NCT01995942
Condition:
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:
Neoplasms
Adenocarcinoma
Rectal Neoplasms
Colorectal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type
Intestinal Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Cystic, Mucinous, and Serous
Adenocarcinoma, Mucinous
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
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
Overall status:
Unknown status
Study design:
Time perspective:
Prospective
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:
Study pop:
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.
Sampling method:
Non-Probability Sample
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)
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Peterborough City Hospital
Address:
City:
Peterborough
Zip:
PE3 9GZ
Country:
United Kingdom
Facility:
Name:
Leighton Hospital
Address:
City:
Crewe
Zip:
CW1 4QJ
Country:
United Kingdom
Facility:
Name:
Royal Cornwall Hospital
Address:
City:
Truro
Zip:
TR1 3LQ
Country:
United Kingdom
Facility:
Name:
Derriford Hospital
Address:
City:
Plymouth
Zip:
PL6 8DH
Country:
United Kingdom
Facility:
Name:
Poole Hospital
Address:
City:
Poole
Zip:
BH15 2JB
Country:
United Kingdom
Facility:
Name:
University Hospital Southampton NHS Foundation Trust
Address:
City:
Southampton
Zip:
SO16 6YD
Country:
United Kingdom
Facility:
Name:
North Manchester General Hospital
Address:
City:
Crumpsall
Zip:
M8 5RB
Country:
United Kingdom
Facility:
Name:
University Hospital of South Manchester
Address:
City:
Wythenshawe
Zip:
M23 9LT
Country:
United Kingdom
Facility:
Name:
Kings Mill Hospital
Address:
City:
Sutton-in-Ashfield
Zip:
NG17 4JL
Country:
United Kingdom
Facility:
Name:
Queen's Hospital, Burton Upon Trent
Address:
City:
Burton-on-Trent
Zip:
Burton-on-Trent
Country:
United Kingdom
Facility:
Name:
Royal Surrey County Hospital
Address:
City:
Guildford
Zip:
GU2 7XX
Country:
United Kingdom
Facility:
Name:
Homerton University Hospital
Address:
City:
London
Zip:
E9 6SR
Country:
United Kingdom
Facility:
Name:
Croydon University Hospital
Address:
City:
Thornton Heath
Zip:
CR7 7YE
Country:
United Kingdom
Facility:
Name:
University Hospital Coventry
Address:
City:
Coventry
Zip:
CV2 2DX
Country:
United Kingdom
Facility:
Name:
Salisbury District Hospital
Address:
City:
Salisbury
Zip:
SP2 8BJ
Country:
United Kingdom
Facility:
Name:
Royal Marsden Hospital
Address:
City:
London And Surrey
Country:
United Kingdom
Facility:
Name:
George Eliot Hospital
Address:
City:
Nuneaton
Zip:
CV10 7DJ
Country:
United Kingdom
Facility:
Name:
Alexandra Hospital
Address:
City:
Redditch
Zip:
B98 7UB
Country:
United Kingdom
Facility:
Name:
South Warwickshire NHS Foundation Trust (Warwick Hospital)
Address:
City:
Warwick
Zip:
CV34 5BW
Country:
United Kingdom
Start date:
June 7, 2013
Completion date:
February 2, 2022
Lead sponsor:
Agency:
Royal Marsden NHS Foundation Trust
Agency class:
Other
Collaborator:
Agency:
Pelican Cancer Foundation
Agency class:
Other
Source:
Royal Marsden NHS Foundation Trust
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT01995942
