Bone Recovery After Treatment Study (BRATS)
Research type
Research Study
Full title
Induction Chemotherapy resets the Bone Marrow Micro-environment facilitating Bone Recovery – A Window of Opportunity for Anabolic Therapy.
IRAS ID
150568
Contact name
Andrew Chantry
Contact email
Sponsor organisation
Sheffield Teaching Hospitals NHS FT
Clinicaltrials.gov Identifier
n/a, n/a
Duration of Study in the UK
6 years, 11 months, 29 days
Research summary
Cancer-induced bone disease ruins patient lives and costs the NHS millions of pounds every year. Patients particularly at risk are those suffering from multiple myeloma. Even when the cancer responds to treatment, patients can experience chronic problems with debilitating bone pain and fractures affecting quality of life (QOL).
Currently, myeloma patients who are eligible, receive treatment with induction chemotherapy (which may be followed by autologous stem cell transplant). We want to answer the question – does induction chemotherapy reset the bone microenvironment? If we can understand how bone behaves through this crucial treatment period, we could direct future research and treatment developments (e.g anabolic agents) and in theory – heal bone. This research could lead to improvements in patient outcomes, reduce unnecessary patient suffering and lower NHS costs caused by cancer related bone disease.
This observational study will commence in 2018 and aims to recruit a first cohort (pilot) of 20 patients from Sheffield Teaching Hospitals who have a new diagnosis of myeloma. The study will be re-opened for a second round of recruitment (cohort 2) of up to 100 patients. Patients will be seen at recruitment and up to monthly during treatment and for twelve-months post treatment (study participation 18-24 months). In total, patients will undergo three whole-body low-dose CT scans, up to monthly blood tests, three bone marrow biopsies, and will be monitored for symptoms (including skeletal events and QOL) by completing 4 questionnaires throughout the study.
We will assess bone disease using radiological reporting, as well as using new innovative software to analyse CT images, which if successful could have future clinical benefits. We will also assess bone biomarkers, histomorphology of bone trephines and DNA/RNA analysis. These findings, as well as the clinical information from the study, will be an invaluable opportunity to comprehensively assess myeloma bone disease.
REC name
Yorkshire & The Humber - Bradford Leeds Research Ethics Committee
REC reference
18/YH/0275
Date of REC Opinion
4 Sep 2018
REC opinion
Further Information Favourable Opinion