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临床试验/NCT02791698
NCT02791698Unknown不适用

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

Bnai Zion Medical Center1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2016年6月最近更新:
适应症

试验速览

阶段
不适用
入组人数
80
试验地点
1
主要终点
Diagnosis of Cushing's syndrome

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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

结局指标

主要结局

Diagnosis of Cushing's syndrome

时间窗: 1 months

次要结局

未报告次要终点

研究者

申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

leonard.saiegh

Doctor

Bnai Zion Medical Center

研究点 (1)

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