PROACT PLUS Registry & Echo Sub-study (version 1.0)
Research type
Research Study
Full title
PROACT PLUS Registry and Echocardiography sub-study: An observational, prospective, cohort study assessing the use of novel echocardiographic tools and troponin to detect early signs of cardiotoxicity in patients treated for breast cancer
IRAS ID
245613
Contact name
Sharareh Vahabi
Contact email
Sponsor organisation
South Tees NHS Foundation Trust
Clinicaltrials.gov Identifier
35193, ISRCTN (submission reference number)
Duration of Study in the UK
3 years, 0 months, 1 days
Research summary
Breast cancer is one of the most common cancers. In the UK 150 people per day are diagnosed. Often breast cancer is treated with anti-cancer drugs, called chemotherapy. Anthracyclines are a type of chemotherapy often used to treat breast cancer and are very effective. However, as with all drugs anthracyclines come with side effects. Heart damage is the most serious side effect. Heart damage can happen at the time of treatment, but symptoms only develop much later.
Detecting heart damage relies on heart scans (called echocardiography, or echo for short). The usual measurements can only identify heart damage when it is already established. Waiting until damage is established means a reduced chance of heart recovery. Unfortunately, anthracycline heart damage can sometimes be severe and affect length and quality of life. Doctors and patients need better ways of detecting heart damage earlier.
This study aims to understand if new echo measurements can be used to detect heart side effects sooner. We don't know yet if these new measurements are better than what is currently done. Some patients are already involved in a linked study called PROACT. These patients have already given their permission for echo studies and analysis. We plan to ask another group of patients receiving chemotherapy as part of standard care but not currently in PROACT, to participate in a study called the PROACT PLUS registry. There will not be any study treatments in the registry, but patients will have additional echo scans performed and blood tests (called troponin). The additional echo analysis is performed on stored echo pictures and is called the PROACT echo sub-study. We plan to follow up the registry patients for 18 months. We plan to combine the information from both trial and registry groups to answer the study questions.
REC name
East Midlands - Nottingham 1 Research Ethics Committee
REC reference
18/EM/0177
Date of REC Opinion
13 Jul 2018
REC opinion
Further Information Favourable Opinion