Stability of Adrenal Biomarkers in Saliva
Research type
Research Study
Full title
A Study of the Stability of Salivary Adrenal Biomarker Samples Under Varying Conditions
IRAS ID
302584
Contact name
Daniel Hawcutt
Contact email
Sponsor organisation
Alder Hey Children’s NHS Foundation Trust
Clinicaltrials.gov Identifier
NA, NA
Duration of Study in the UK
0 years, 2 months, 1 days
Research summary
Previous studies have established saliva sampling to be a good indicator for how much cortisol is circulating in blood. Saliva sampling has a number of advantages over blood testing such as, being less traumatic for patients and reducing hospital visits. This is especially important for children who require regular blood tests to see the medication they are taking is working well. Limitations are that salivary cortisol as it is not always detectable; however, this is offset by the inclusion of salivary cortisone measurements.
Furthermore storage conditions may affect the levels of hormones found in the samples and therefore may compromise the results. As such this study will look to at how concentration levels of cortisol or cortisone in samples stored under various conditions, after collection and before they reach the laboratory are affected.
This will be done in 4 steps, the first of which will be to ensure that our method or collection, which requires participants to give us 4 samples in the space of 15minutes, doesn’t itself affect the results. The next step will be a comparison between two collection kits to see which one participant prefer. The third stage will be to compare samples stored at room temperature, fridge and freezer conditions and the final stage will be to compare methods of returning samples to the hospital (bus/car journey vs post). This study will be conducted all at Alder Hey Hospital and participants will attend the Clinical Research Facility there, to provide their samples. Participant will be made up of healthy adult staff members working at the hospital and as participants can take part in all stages of the study, the maximum number of visits will be four per individual. The study will be sponsored by the Alder Hey Hospital and funded through the Hugh Greenwood grant.REC name
North West - Greater Manchester Central Research Ethics Committee
REC reference
21/NW/0301
Date of REC Opinion
9 Dec 2021
REC opinion
Further Information Favourable Opinion