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

This study is currently recruiting participants.
Verified October 2016 by leonard.saiegh, Bnai Zion Medical Center
Sponsor:
ClinicalTrials.gov Identifier:
NCT02791698
First Posted: June 7, 2016
Last Update Posted: October 27, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
leonard.saiegh, Bnai Zion Medical Center
  Purpose
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.

Condition
Cushing Syndrome

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Accuracy of Late Night Urinary Free Cortisol/Creatinine and Hair Cortisol in Cushing's Syndrome Diagnosis

Resource links provided by NLM:


Further study details as provided by leonard.saiegh, Bnai Zion Medical Center:

Primary Outcome Measures:
  • Diagnosis of Cushing's syndrome [ Time Frame: 1 months ]

Biospecimen Retention:   Samples Without DNA
urine and hair

Estimated Enrollment: 80
Study Start Date: June 2016
Estimated Study Completion Date: May 2020
Estimated Primary Completion Date: May 2019 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02791698


Contacts
Contact: Leonard Saiegh, M.D. 0097248359931 leonard.saiegh@gmail.com

Locations
Israel
Saiegh leonard Recruiting
Haifa, Israel, 24908
Contact: Leonard Saiegh    506267262    leonard.saiegh@gmail.com   
Contact: Michal Yeiches    0528283062    yeiches@gmail.com   
Sponsors and Collaborators
Bnai Zion Medical Center
Investigators
Principal Investigator: Leonard Saiegh, M.D. Bnai Zion Medical Center
  More Information

Responsible Party: leonard.saiegh, Doctor, Bnai Zion Medical Center
ClinicalTrials.gov Identifier: NCT02791698     History of Changes
Other Study ID Numbers: 0049-15-BNZ
First Submitted: May 24, 2016
First Posted: June 7, 2016
Last Update Posted: October 27, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by leonard.saiegh, Bnai Zion Medical Center:
cortisol
hair
urinary

Additional relevant MeSH terms:
Cushing Syndrome
Syndrome
Disease
Pathologic Processes
Adrenocortical Hyperfunction
Adrenal Gland Diseases
Endocrine System Diseases
Hydrocortisone 17-butyrate 21-propionate
Hydrocortisone acetate
Cortisol succinate
Hydrocortisone
Anti-Inflammatory Agents