The Accuracy of Late Night Urinary Free Cortisol/Creatinine and Hair Cortisol in Cushing's Syndrome Diagnosis
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
- 否
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
leonard.saiegh
Doctor
Bnai Zion Medical Center
