REVEAL version 1
Research type
Research Study
Full title
Molecular profiling of tumour tissue, circulating nucleic acids and circulating tumour cells in early stage breast cancer.
IRAS ID
173297
Contact name
Carlos Caldas
Contact email
Sponsor organisation
R&D Office
Clinicaltrials.gov Identifier
A093584, R&D Number
Duration of Study in the UK
6 years, 0 months, 0 days
Research summary
REVEAL is a translational research study that will collect tissue and blood samples from women with breast cancer who have undergone primary curative surgery at Addenbrooke’s Hospital, Cambridge. The study will involve the collection of serial blood samples over six years, commencing immediately before surgery. These samples will be used for the isolation of tumour specific circulating DNA (ctDNA) and circulating tumour cells (CTCs), which can be found in the bloodstream of individuals with cancer. The measurement of ctDNA and CTCs provides an opportunity to study tumour specific parameters in real-time using a minimally invasive technique that can be repeated at serial intervals.
The aim of this study is to determine whether the rate at which ctDNA and CTC levels decrease post surgery correlates with long term prognosis, and to ascertain the clinical significance of detecting ctDNA and/or CTCs following curative treatment. This research will address whether the measurement of ctDNA and CTCs in this setting can be integrated into clinical practice to predict and possibly detect early relapse. In addition, the study will characterise the molecular profile of breast tumour tissue collected during surgery, and findings will be correlated to long-term survival statistics. This molecular information may prove useful in guiding the selection of optimal therapies in the future.
REC name
North West - Liverpool Central Research Ethics Committee
REC reference
15/NW/0994
Date of REC Opinion
24 Dec 2015
REC opinion
Favourable Opinion