Biomarker Expression in Patients With ACTH-Dependent Cushing's Syndrome Before and After Surgery
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 16-006331
NCT ID: NCT02922257
Sponsor Protocol Number: FKBP5-700
About this study
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.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- ≥ 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.
Exclusion Criteria:
- 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.
- 8 weeks prior to first specimen collection and/or during the study period.
- 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.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator Irina Bancos, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available