NCT04201444

Brief 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
51

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2021

Geographic Reach
1 country

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 4, 2019

Completed
3 months until next milestone

First Posted

Study publicly available on registry

December 17, 2019

Completed
1.2 years until next milestone

Study Start

First participant enrolled

March 10, 2021

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 10, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 10, 2022

Completed
Last Updated

July 18, 2023

Status Verified

July 1, 2023

Enrollment Period

1.3 years

First QC Date

September 4, 2019

Last Update Submit

July 17, 2023

Conditions

Cushing Disease

Keywords

UFCLNSCHair cortisolmedical treatment

Outcome Measures

Primary Outcomes (1)

  • Evaluate cortisol chronic tissue impregnation

    Hypercortisolism will be controlled using 3 cm scalp hair sample in which Hair Cortisol will be measured in patients with Cushing Disease (CD) receiving a medical treatment.

    3 months after inclusion day

Secondary Outcomes (8)

  • Evaluate Hair Cortisol (Hcort) measure for Cushing Disease control

    3 months after inclusion day

  • Compare cortisol tissue impregnation thanks to Hair Cortisol measurements in patients with CD receiving a medical treatment and patients control

    3 months after inclusion day

  • Compare cortisol tissue impregnation thanks to Hair Cortisol measurements in patients cured from CD and patient with bilateral adrenalectomy

    3 months after inclusion day

  • Evaluate Hair Cortisol intra-individual variability

    At day 0 and day 90

  • Evaluate UFC intra-individual variability

    3 months after inclusion day

  • +3 more secondary outcomes

Study Arms (3)

Patient group

EXPERIMENTAL
Diagnostic Test: Patient group

Remission control group

ACTIVE COMPARATOR
Diagnostic Test: Remission control group

Bilateral surrenalectomy control group

ACTIVE COMPARATOR
Diagnostic Test: Bilateral surrenalectomy control group

Interventions

Patient groupDIAGNOSTIC_TEST

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

Patient group
Remission control groupDIAGNOSTIC_TEST

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

Remission control group
Bilateral surrenalectomy control groupDIAGNOSTIC_TEST

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

Bilateral surrenalectomy control group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • In the three groups:
  • Age \> 18
  • Cushing's disease medical history: histology confirming an ACTH staining adenoma, or ACTH-dependant Cushing syndrome with MRI confirmation of pituitary adenoma, or pituitary secretion of ACTH confirmed with petrosal sinus gradient
  • Written informed consent
  • Hair length ≥ 3 cm
  • In patient group:
  • Persistent CD diagnosed on usual criteria in expert centers including overt hypercortisolism with at least 2 UFC \> 1.5 N prior to the start of medical treatment
  • Previous treatment with pasireotide, cabergoline, metyrapone, ketoconazole (alone or in association) AND hypercortisolism considered as controlled for at least 3 months based on 2 normal UFC.
  • In remission control group:
  • o Patients cured 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)
  • In bilateral surrenalectomy control group:
  • o 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.

You may not qualify if:

  • In the three groups:
  • Renal Failure (Cl \< 30 mL/min)
  • Non-compliant patients
  • Hair length \< 3 cm
  • Severe depression and psychosis
  • Drug addiction and active alcoholism
  • Myocardial infarction or cerebrovascular accident \< 3 months
  • Intense physical activity (marathon runner)
  • Night-shifters
  • Obesity with BMI \> 35 kg/m2
  • Type 1 diabetes
  • Type 2 diabetes with HbA1C \> 9 %
  • In patient group:
  • Patients receiving mifepristone and/or mitotane
  • Patients treated with anticortisolic agents during the titration process
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Service d'Endocrinologie - CHU Caen

Caen, 14000, France

Location

Service d'endocrinologie - HCL

Lyon, 69000, France

Location

Service d'Endocrinologie, Diabète et Maladies Métaboliques - APHM

Marseille, 13000, France

Location

CIC d'Endocrinologie, Maladies Métaboliques et Nutrition - CHU de Nantes

Nantes, 44000, France

Location

Service d'Endocrinologie - APHP Cochin

Paris, 75000, France

Location

Service d'Endocrinologie et des Maladies de la Reproduction - APHP Bicêtre

Paris, 75000, France

Location

Service d'endocirnologie, diabète, nutrition, Hôpital Haut Lévêque - CHU de Bordeaux

Pessac, 33604, France

Location

Related Publications (1)

  • Mohammedi K, Bertherat J, Raverot G, Drui D, Reznik Y, Castinetti F, Chanson P, Fafin M, Brossaud J, Tabarin A. Evidence of Persistent Mild Hypercortisolism in Patients Medically Treated for Cushing Disease: the Haircush Study. J Clin Endocrinol Metab. 2023 Sep 18;108(10):e963-e970. doi: 10.1210/clinem/dgad251.

    PMID: 37144820DERIVED

MeSH Terms

Conditions

Pituitary ACTH Hypersecretion

Condition Hierarchy (Ancestors)

HyperpituitarismPituitary DiseasesHypothalamic DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesEndocrine System Diseases

Study Officials

  • Antoine TABARIN, Pr

    University Hospital, Bordeaux

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 4, 2019

First Posted

December 17, 2019

Study Start

March 10, 2021

Primary Completion

June 10, 2022

Study Completion

June 10, 2022

Last Updated

July 18, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations

FR(7)