Endogenous Cushing’s syndrome: cyclicity in hypercortisolaemia

• Research type

  Research Study

• Full title

  Endogenous Cushing’s syndrome: investigating cyclicity in hypercortisolaemia

• IRAS ID

  292790

• Contact name

  John Wass

• Contact email

  john.wass@nhs.net

• Sponsor organisation

  Oxford University Hospitals NHS Foundation Trust

• Duration of Study in the UK

  2 years, 0 months, 1 days

• Research summary

  Background:
  Cyclical Cushing’s syndrome (CS) is a rare disorder. It can be defined as repeated episodes of cortisol excess in blood, saliva and/or urine with intervening normal cortisol levels, on at least 2-3 occasions. Each episode can last for a variable duration, occuring regularly or irregularly. This syndrome should be strongly suspected in patients with symptoms or signs of hypercortisolism but normal cortisol levels when screened biochemically. Responses to treatment must be closely monitored because fluctuations in underlying corticosteroid production can leave the patient susceptible to periods of hyper- and/or hypo-cortisolism. The percentage of true cyclical versus non-cyclical course of Cushing’s syndrome is largely unknown. Diagnosing a cyclical version of Cushing’s can be clinically challenging as affected individuals may return normal laboratory results if analysis is undertaken during a quiescent period.
  Study hypothesis
  • Cyclical CS is under diagnosed.
  • In post-operative CS patients, who have a recurrence of CS, hypercortisolaemia is largely cyclical, especially in early stages.
  • Patients with strong clinical suspicion for CS but misleading laboratory tests may still have CS and need a longer duration of repeated investigation.
  Timeline
  The duration of this study is expected to be 2 years.
  Study design: a prospective observational study over time in which CS patients are divided into sub-groups and serial testing is done over 6 months period for each patient.
  Patients are involved from 6 Endocrinology centres around the UK:
  1. Oxford University Hospitals NHS Foundation Trust
  2. University Hospitals Birmingham NHS Foundation Trust
  3. Sheffield Teaching Hospitals NHS Foundation Trust
  4. Cambridge University Hospitals NHS Foundation Trust
  5. Barts Health NHS Foundation Trust
  6. University Hospitals of Leicester NHS Foundation Trust

  This study is funded by HRA-Pharma grant for clinical studies.

• REC name

  Wales REC 3

• REC reference

  24/WA/0101

• Date of REC Opinion

  29 Mar 2024

• REC opinion

  Favourable Opinion