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Hair Cortisol and Cushing's Disease

NCT04201444 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 51

Last updated 2023-07-18

No results posted yet for this study

Summary

The biochemical tools usable to assess the control of hypercortisolism in patients with Cushing's disease receiving medical treatments are debatable. The aim of the study is to compare the results of the measurement of cortisol and cortisone using high-performance liquid chromatography-tandem mass spectrometry (LC-MS/MS) in scalp hair (so called "Hair Cortisol") to that of 24h urinary free cortisol (UFC) and late night salivary cortisol (LNSC) for the monitoring of medical therapy in patients with Cushing's disease (CD).

Conditions

  • Cushing Disease

Interventions

DIAGNOSTIC_TEST

Patient group

Patients with Cushing Disease (CD) receiving a medical treatment: n = 30 Plasmatic cortisol UFC Urine biocollection Salive biocollection

DIAGNOSTIC_TEST

Remission control group

Patients in remission of CD and having recovered a normal pituitary function for at least 12 months following pituitary surgery (normal UFC associated to: cortisol suppression following dexamethasone suppression test, or normal LNSC, or midnight serum cortisol \< 200 nmol/L) n = 15 Plasmatic cortisol UFC Urine biocollection Salive biocollection Haircortisol

DIAGNOSTIC_TEST

Bilateral surrenalectomy control group

Patients with previous CD, treated with bilateral adrenalectomy and receiving weight adjusted doses of hydrocortisone for at least 6 months. Last daily dose of Hydrocortisone should be administered no later than 5 pm. n = 15 Plasmatic cortisol UFC Urine biocollection Salive biocollection Haircortisol

Sponsors & Collaborators

  • University Hospital, Bordeaux

    lead OTHER

Principal Investigators

  • Antoine TABARIN, Pr · University Hospital, Bordeaux

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-10
Primary Completion
2022-06-10
Completion
2022-06-10

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04201444 on ClinicalTrials.gov