VALIDATE
Research type
Research Study
Full title
A study of the utility of saliVary Androgen profiLes as a diagnostic tool in chilDren with premATure aDrenarchE (VALIDATE)
IRAS ID
335258
Contact name
Christopher Parry
Contact email
Sponsor organisation
ALDER HEY CHILDREN'S NHS FOUNDATION TRUST
Duration of Study in the UK
0 years, 11 months, 30 days
Research summary
Premature pubarche (PP) is a term used to describe children with pubic and underarm hair growth and adult body odour without breast development in girls younger than eight and testicular development in boys younger than nine. This condition is most commonly caused by Exaggerated Adrenache (EA). EA is usually diagnosed by hormone levels in blood or urine tests; however a blood test can be an upsetting experience for a child and urine samples can be difficult to collect. For these reasons, analyzing hormone levels in saliva samples rather than blood or urine tests may be a more tolerable and more cost-effective option. This study aims to gather pilot information on the use of saliva tests to diagnose this condition. The information will be used to design a further, more definitive study on the use of saliva tests. Girls aged six to eight and boys aged six to nine presenting to the endocrine clinic at Alder Hey Children’s Hospital with PP will be invited to partake in the study. They will be asked to provide an early morning saliva sample which is to be taken at home and bought to clinic at the next opportunity. We will measure levels of the following hormones: androstenedione, 11-ketotestosterone, 11β-hydroxyandrostenedione and testosterone, in the saliva samples and compare the levels of these hormones in children with EA and healthy age and sex matched children. We will also look at the acceptability of saliva tests and their effectiveness compared to other diagnostic methods such as blood and urine tests. To collect this information, we will ask participants to complete a questionnaire and score activities involved in the study from one to ten. Ultimately, this study hopes to provide evidence for the use and acceptability of saliva tests for the diagnosis of EA.
REC name
London - Hampstead Research Ethics Committee
REC reference
23/PR/1398
Date of REC Opinion
7 Dec 2023
REC opinion
Favourable Opinion