NCT02791698

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2016

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

May 24, 2016

Completed
8 days until next milestone

Study Start

First participant enrolled

June 1, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 7, 2016

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2019

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2020

Completed
Last Updated

January 18, 2019

Status Verified

January 1, 2019

Enrollment Period

2.9 years

First QC Date

May 24, 2016

Last Update Submit

January 17, 2019

Conditions

Cushing Syndrome

Keywords

cortisolhairurinary

Outcome Measures

Primary Outcomes (1)

  • Diagnosis of Cushing's syndrome

    1 months

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Saiegh leonard

Haifa, 24908, Israel

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

urine and hair

MeSH Terms

Conditions

Cushing Syndrome

Condition Hierarchy (Ancestors)

Adrenocortical HyperfunctionAdrenal Gland DiseasesEndocrine System Diseases

Study Officials

  • Leonard Saiegh, M.D.

    Bnai Zion Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Leonard Saiegh, M.D.

CONTACT

0097248359931leonard.saiegh@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

May 24, 2016

First Posted

June 7, 2016

Study Start

June 1, 2016

Primary Completion

May 1, 2019

Study Completion

May 1, 2020

Last Updated

January 18, 2019

Record last verified: 2019-01

Data Sharing

IPD Sharing
Will not share

Locations

IL(1)