FOrMAT
Research type
Research Study
Full title
FOrMAT: Feasibility of a Molecular characterisation Approach to Treatment
IRAS ID
128520
Contact name
Naureen Starling
Contact email
Sponsor organisation
The Royal Marsden NHS Foundation Trust
Research summary
This is a single-centre prospective translational research study involving the collection and analysis of tumour tissue, blood samples and clinical data from patients with locally advanced/metastatic gastrointestinal cancer. The aim of the study is to assess the feasibility of genetically sequencing tumours to identify patients who have molecular characteristics that mean they might be suitable for targeted drugs.
These molecular characteristics will be determined through analysis of tumour DNA and RNA extracted from tissue samples (these may be either archival samples or obtained through a repeat biopsy). A blood sample will be collected for analysis of circulating tumour DNA and germline DNA. Clinical, pathological and demographic data will be collected into a research database to assist with decision-making regarding the clinical relevance of any mutations found and to facilitate further research.
Sequencing results will be discussed by the Sequencing Tumour Board to determine the relevance of any abnormalities found. The patient’s treatment options will be cross-referenced against standard recommendations (including national guidelines), their potential suitability for current clinical trials (either within the Gastrointestinal unit or Phase 1 unit) and the potential availability (e.g. via an individual funding request or compassionate access program) of accessing drugs on an individual patient basis. Results will then be disclosed to the patient. The patient’s views on cancer research will also be assessed by a baseline questionnaire.
This is not a therapeutic study and this protocol does not dictate treatment options, but rather aims to use genetic sequencing to facilitate the personalization of future treatments.
In addition, this study involves optional biopsies and blood samples when a patient’s response to treatment is assessed. This would allow the comparison of molecular characteristics between their baseline and post-treatment samples and the potential identification of any changes that might be associated with response or resistance to treatment.
REC name
London - Stanmore Research Ethics Committee
REC reference
13/LO/1274
Date of REC Opinion
17 Sep 2013
REC opinion
Favourable Opinion