Developing a new blood test for diagnosing the start of puberty
Investigation of the utility of transcriptomic and epigenetic data for diagnosing the onset of puberty.
- Hospital – Speciality: Laboratories – Biochemistry
- Study type – Pilot diagnostic test development and accuracy study
- Funder: Part of the Higher Specialist Scientist Training Programme for NHS England
Currently to make a diagnosis of puberty in children with early or delayed signs of puberty, a gonadotrophin stimulation test is needed. This involves a plastic tube being inserted into the child’s vein and a medicine given to stimulate the body’s production of hormones involved in puberty. Several blood samples are then taken over the next hour. Sometimes there are side effects from the medicine given such as nausea or headache. Children have to be in hospital for several hours to have this test.
The researchers have begun to develop a new test to replace these gonadotrophin stimulation tests. This new test is based on measuring the activity level of the genes in the blood. The new test would require just one blood collection and would not need a drip or an injection of medicine. The purpose of this study is to compare the results from this new test with the results from the gonadotrophin tests. To do this the researchers need a group of children to have both the old and new tests as part of this research study.
Children attending Royal Manchester Children’s Hospital for a Gonadotrophin-releasing hormone (GnRH) Stimulation test.
Patients will be identified by their Consultant Paediatric Endocrinologist at the time they decide a GnRH test is required. The consultant will then provide the family with the appropriate information sheets and consent forms. For any children who have a GnRH test booked but there is no opportunity to provide this information in clinic then it will be posted out to them.
Study open date and expected length
Opened: 30 June 2023
Expected end date: 30 September 2025
Pending – this study is currently active
Telephone number: 0161 701 1678
Email address: firstname.lastname@example.org / email@example.com
- IRAS number: 310719