MAGENTA - v1.2
Research type
Research Study
Full title
MAGENTA: METABONOMIC-GENOMIC SIGNATURE CORRELATES OF CLINICAL RESISTANCE IN METASTATIC CANCER TREATED WITH ANTI-EGFR THERAPY
IRAS ID
139411
Contact name
Becky Ward
Contact email
Sponsor organisation
Imperial College London
Research summary
Patients presenting to the Cancer Centre will receive an information sheet broadly describing research into the molecular biology of metastatic cancer. It will be made clear to patients that clinical information will be coded and linked to the molecular information. Security of the data will be ensured by establishing a coded linked system for which there will be keyholders (Mr Adam Beech and Miss Mohana Suppiah), and data controllers (Dr Harpreet Wasan and Prof Bob Brown). We will explain that thousands of such molecules are generated from these analyses and therefore to focus on individual detail is inappropriate. We will also explain that none of this information will be returned to the patient, and that it has no implication for patient management today. They will also be told that no additional tests other than those which are clinically indicated will be performed, but a small additional volume (20-40ml, which amounts to 4-8 teaspoons) of blood will be taken when appropriate blood tests are performed. Should further biopsies of tissue, fluid or blood be clinically indicated we should like to archive tissue/fluid from these samples at the Hammersmith Tissue Bank. A population based genome wide, multiplatform profilling approach will be adopted. The deliverables principally include comprehensive molecular classification of metastatic cancer in an selected clinical population presenting to the Cancer Centre who will be receiving Cetuximab therapy. Linkage to prospectively collected, ontologically appropriate clinical information coded and updated in real time is a central component of this clinical profiling approach, which will be facilitated by our collaboration with the microarray centre. Targets of potential clinical utility identified by this approach will be explored fully in terms of their molecular description. This is likely to necessitate a return to the same sample, plus analyses of a validation set of clinical samples in order to assess individual molecules/genes at the level of DNA, RNA, proteins and metabolites in order to achieve a comprehensive understanding of these molecules in multiple clinical and clinicopathological contexts in metastatic cancer. No molecule identified will be used in the individual clinical management prospectively of patients, and further ethics submissions will be placed if clinical activities are to be potentially altered by discoveries regarding these molecules.
REC name
London - Queen Square Research Ethics Committee
REC reference
14/LO/1650
Date of REC Opinion
10 Nov 2014
REC opinion
Further Information Favourable Opinion