The Accuracy of Late Night Urinary Free Cortisol/Creatinine and Hair Cortisol in Cushing's Syndrome Diagnosis

January 17, 2019 updated by: leonard.saiegh, Bnai Zion Medical Center
The investigators will conduct a prospective study, in which they will determine sensitivity, specificity and diagnostic accuracy of late evening urinary free cortisol concentration/creatinine and hair cortisol in differentiating Cushing's syndrome from Pseudo-Cushing's syndrome.

Study Overview

Status

Unknown

Conditions

Detailed Description

24h-Urine free cortisol (24h-UFC) and other screening tests may turn out normal in Cushing's syndrome (CS) patients, probably due to high variability and cyclicity in cortisol secretion. To rule out cyclic cortisol secretion, the recommendation is to repeat 24h-UFC measurements on different and several occasions. As 24h-UFC is technically inconvenient, especially in the elderly and in women, compliance may not be optimal, and results could be falsely low especially if collection is not properly conducted.

Alternatively, the status of cortisol circadian rhythm and urinary cortisol secretion may be assessed in a non-invasive and more convenient manner through the measurement of late evening urinary free cortisol concentration/creatinine concentration (Late-UFC). These measurements have been useful in screening outpatients for CS, but their performances have not been properly and enough validated.

It appears that the assessment of Late-UFC can offer a non-invasive and convenient diagnostic tool for evaluating cortisol circadian rhythm and urinary cortisol secretion in ambulatory populations, especially in the case of patients for whom 24h-UFC should be repeated yet is technically not convenient to perform.

Hair sample testing has gained increasing attention and recognition over the last 20 years, especially for detecting illegal drug use and for other forensic purposes. This is because hair provides a relatively long-term retrospective record of levels of various bio-markers in the body.

In light of the foregoing evidence, it has been suggested that hair cortisol measurement could be a novel method for assessing dynamic systemic cortisol exposure, and could provide unique historical information on variation and cyclicity in cortisol exposure.

The investigators will conduct a prospective cohort study which will include patients referred to outpatient endocrinology clinic for medical evaluation due to CS suspicion or adrenal incidentaloma evaluation. Participants will be asked to provide informed consent before study enrollment. All Participants will be asked to perform the routine screening tests for CS diagnosis. On the same day participants will collect the 24h-UFC, they will be asked to empty their urinary bladder at 22:00 hour to the urinary collection bottle, and to give a single urinary sample at 24:00 hour for Late-UFC determination.

Immediately after study enrollment, hair sample of approximately 100-150 strands and 2-3 cm long will be collected from the posterior vertex, and cortisol concentration in hair will be determined.

All patients enrolled will be diagnosed as "CS", "Pseudo-Cushing's syndrome" or "undermined". CS will be classified as ACTH-dependent CS or ACTH-independent CS. ACTH-dependent CS will be diagnosed when at least two screening tests for CS are positive (not including Late-UFC and HC), normal or elevated basal plasma ACTH concentration, and positive ACTH stained histology and/or post-surgical hypoadrenalism. ACTH-independent CS will be diagnosed when at least one screening test is positive, depressed basal plasma ACTH concentration (ACTH concentration below 2.2 pmol/L) and the patient has adrenal-post-surgical hypoadrenalism. Patients will be diagnosed as "Pseudo-Cushing's syndrome" when only one screening test is positive out of at least three tests performed, patients harboring no typical features for CS, and there is no deterioration in biochemical or clinical status during the study follow-up. Patients will be diagnosed as "undermined" when harboring two or more positive screening tests, yet the clinical and biochemical profile do not support definitive diagnosis.

To address the questions of the study, the investigators will compare the two groups of "CS" and "Pseudo-Cushing's syndrome" determining sensitivity, specificity and diagnostic accuracy of Late-UFC and Hair cortisol in differentiating Cushing's syndrome from Pseudo-Cushing's syndrome.

Study Type

Observational

Enrollment (Anticipated)

80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 76 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

patients referred to our outpatient endocrinology clinic for medical evaluation due to Cushing's syndrome suspicion or adrenal incidentaloma evaluation

Description

Inclusion Criteria:

1. Patients referred to our outpatient endocrinology clinic for medical evaluation due to CS suspicion or adrenal incidentaloma evaluation

Exclusion Criteria:

  1. Serum creatinine level concentration above 1.5 mg/deciliter
  2. Systemic, dermal or nasal steroid use
  3. Chronic inflammatory disease
  4. Any infectious disease requiring hospitalization or more that 2 weeks of antibiotic treatment in the previous 3 months

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Diagnosis of Cushing's syndrome
Time Frame: 1 months
1 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bnai Zion Medical Center

Investigators

  • Principal Investigator: Leonard Saiegh, M.D., Bnai Zion Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2016

Primary Completion (Anticipated)

May 1, 2019

Study Completion (Anticipated)

May 1, 2020

Study Registration Dates

First Submitted

May 24, 2016

First Submitted That Met QC Criteria

June 1, 2016

First Posted (Estimate)

June 7, 2016

Study Record Updates

Last Update Posted (Actual)

January 18, 2019

Last Update Submitted That Met QC Criteria

January 17, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0049-15-BNZ

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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