PRIME-ACT - version 1.3
Research type
Research Study
Full title
Identification of new biomarkers for classification and management of adrenocortical tumours (PRecIsion MEdicine in AdrenoCortical Tumours (PRIME-ACT) Study).
IRAS ID
261291
Contact name
Cristina L Ronchi
Contact email
Sponsor organisation
University of Birmingham
Clinicaltrials.gov Identifier
MR/R002339/1, Medical Research Council (MRC) Clinical Research Training Fellowship ; ENSAT-HT (633983), ENSAT-HT
Duration of Study in the UK
2 years, 11 months, 31 days
Research summary
Tumours of the adrenal gland are frequent in the general population and are mostly harmless. However, in about one third of cases, they can secrete steroid hormones in excess and be responsible for clinical syndromes associated with cardiovascular and/or metabolic diseases. In the rare situation that these tumours are cancerous (adrenocortical carcinomas, ACC), they tend to be highly aggressive. About half of the patients who had an ACC removed see the tumour come back within 2 years and most die within 5 years from diagnosis.
In this study, we intend to answer to the following important open questions for patients with adrenal tumours:
• Are there any clinical parameters or biological molecules that can clearly distinguish benign from malignant tumours and steroid-producing from clinically indolent ones? May these parameters also predict the clinical outcome of patients with adrenal tumours?
• Follow-up of patients with ACC currently requires frequent scans that are expensive, result in increased radiation exposure and cannot always answer diagnostic questions. Can we identify any other markers that can improve surveillance of these patients?
• No effective treatment exists nowadays for patients with advanced stage ACC. Are there any molecular alterations that can be targeted by new drugs?
Our ultimate aim will be to establish and validate easily applicable methods to transfer our diagnostic and prognostic tools into the clinical practice, for an individualised management of patients with adrenal tumours.REC name
North West - Preston Research Ethics Committee
REC reference
20/NW/0207
Date of REC Opinion
5 Jun 2020
REC opinion
Further Information Favourable Opinion