Prospective, Non-interventional Clinical Study of Biomarker Expression in Patients With ACTH-Dependent Cushing's Syndrome Before and After Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 26
- 主要终点
- Gene expression levels
研究概览
简要总结
This study will investigate the potential for FK506 binding protein 5 (FKBP5) (and other gene expression markers, for example pentraxin 3 [PTX-3], serum/glucocorticoid regulated kinase 1 [SGK1], and glycogen synthase kinase 3 beta [GSK3b]) to be developed as a biomarker for use in diagnosis of Cushing's syndrome, assessment of effectiveness of medical or surgical treatment, and detection of relapse of endogenous Cushing's syndrome after surgery.
详细描述
This study will investigate the potential for FK506 binding protein 5 (FKBP5) (and other gene expression markers, for example pentraxin 3 [PTX-3], serum/glucocorticoid regulated kinase 1 [SGK1], and glycogen synthase kinase 3 beta [GSK3b]) to be developed as a biomarker for use in diagnosis of Cushing's syndrome, assessment of effectiveness of medical or surgical treatment, and detection of relapse of endogenous Cushing's syndrome after surgery.
The primary study hypothesis is that FKBP5 levels are elevated in patients with Cushing's syndrome, and these levels decrease after successful surgical treatment.
This is a non-randomized specimen collection study with pre- and post-surgery follow-up periods. This study will be performed in patients with adrenocorticotropic hormone (ACTH)-dependent Cushing's syndrome scheduled for curative surgery and followed until relapse of endogenous Cushing's syndrome or up to 3 years post-surgery. No study medication will be given.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥ 18 years of age.
- •Has a documented diagnosis of ACTH-dependent, endogenous Cushing's syndrome and is scheduled for curative surgery.
- •Must be able to comprehend and sign an approved Informed Consent Form (ICF) and other applicable study enrollment documents.
排除标准
- •Plans for pre-operative and/or intra-operative use of glucocorticoid ("steroid cover").
- •Use any of the following treatments for Cushing's syndrome, as specified:
- •4 weeks prior to first specimen collection and/or during the study period.
- •Adrenostatic medications (metyrapone, ketoconazole, fluconazole, aminoglutethimide, LCI699 or etomidate etc).
- •Short-acting somatostatin analogs (octreotide, pasireotide).
- •6 weeks prior to first specimen collection and/or during the study period.
- •o Mifepristone.
- •8 weeks prior to first specimen collection and/or during the study period.
- •o Neuromodulator drugs that act at the hypothalamic-pituitary level: serotonin antagonists (cyproheptadine, ketanserin, retanserin), dopamine agonists (bromocriptine, cabergoline), gamma-aminobutyric acid agonists (sodium valproate), and somatostatin receptor ligands (octreotide long-acting release [LAR], pasireotide LAR, lanreotide).
- •Concomitant use of the following due to their potential to stimulate the expression of FKBP5:
- •Testosterone or other steroid hormone analogues.
- •Oral contraceptives or hormonal replacement therapy.
- •History of illness that the Principal Investigator (PI) considers could interfere with or affect the conduct, results, and/or completion of the clinical trial.
- •Pregnancy or breastfeeding.
结局指标
主要结局
Gene expression levels
时间窗: three years
Change in FKBP5 expression levels from baseline to after surgical treatment but prior to glucocorticoid replacement therapy
次要结局
未报告次要终点