NCT03974789进行中（未招募）不适用
Discriminant Capacity and Thresholds of Salivary Cortisol in Chemiluminescence in the Diagnosis of Hypercorticisms: Phase III Diagnostic Evaluation Study
Centre Hospitalier Universitaire de Nīmes1 个研究点 分布在 1 个国家目标入组 380 人开始时间: 2019年7月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 380
- 试验地点
- 1
- 主要终点
- Salivary cortisol measured by Roche Elecsys cortisol kit
研究概览
简要总结
Automated immunodosage methods (Roche Elecsys cortisol and IDS cortisol dosing kits) offer a simple and inexpensive technology routinely used in a medical biology laboratory. They can be used to define robust diagnostic thresholds for salivary cortisol for the diagnosis of Cushing's syndrome and pseudo-Cushing combining the three tests performed as part of the patient's usual management. (ie two urinary free cortisol (UFC), the dexamethasone suppression test, and Diurnal variation of plasma cortisol).
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patient is under consultation in the department of metabolic and endocrine disorders at the CHU Nimes for diagnosis or follow-up of hypercortisol assessment
- •The patient must be a member or beneficiary of a health insurance plan
排除标准
- •The patient is pregnant, parturient or breastfeeding
- •The patient has a cardiovascular or metabolic state against the indication of dexamethasone
- •- Patient with DFG < 30 ml/min/1.73 m2
- •The patient has suffered urinary incontinence rendering 24-hour urinary collection impossible or non-interpretable
- •The patient has a urinary catheter
- •The patient is taking corticoids (oral, inhaled, intra-venous or cutaneous)
- •.Patient exposed to interfering treatments (Itraconazole, ritonavir, megestrol acetate, medroxyprogesterone acetate, TSH, estrogen-progestogen pill, hormonal coil)
- •The subject is in a period of exclusion determined by a previous study
- •The subject opposes their participation in the study
- •It is impossible to give the subject informed information
- •The patient is under safeguard of justice or state guardianship
结局指标
主要结局
Salivary cortisol measured by Roche Elecsys cortisol kit
时间窗: Day 1 (at screening)
nmol/l
Salivary cortisol measured by IDS cortisol dosing kit at screening
时间窗: Day 1 (at screening)
nmol/l
次要结局
- Salivary cortisol measured by Roche Elecsys cortisol kit(Day 2 and Day 3)
- Salivary cortisol measured by IDS cortisol dosing kit(Day 2 and Day 3)
- Salivary cortisol measured measured by LC-MS/MS(Day 1, 2 and 3)
- Dexamethasone suppression test(Day 4)
- Diurnal variation of plasma cortisol(Day 3)
- Urinary free cortisol(Day 3)
研究者
研究点 (1)
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