Cushing Syndrome Clinical Trial
Official title:
Randomized Control Trial of Adrenalectomy Versus Observation for Subclinical Hypercortisolism
Verified date | May 2018 |
Source | National Institutes of Health Clinical Center (CC) |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Background:
- Adrenal tumors are a common kind of tumor. Some of these secrete extra cortisol into the
body, which can lead to diabetes, obesity, and other diseases. Some people with extra
cortisol will show symptoms like bruising and muscle weakness. Others will show no signs.
This is called subclinical hypercortisolism. Some of these adrenal tumors become malignant.
Researchers want to know the best way to treat people with subclinical hypercortisolism. They
want to know if removing the tumor by surgery reduces the long-term effects of the disease.
Objectives:
- To see if removing an adrenal tumor by surgery improves blood pressure, diabetes, obesity,
osteoporosis, or cholesterol, and cancer detection.
Eligibility:
- Adults 18 and older with an adrenal tumor and high cortisol levels.
Design:
- Participants will be screened with medical history, blood tests, and a computed
tomography (CT) scan.
- Participants will have a baseline visit. They will have blood and urine tests and 7
scans. For most scans, a substance is injected through a tube in the arm. Participants
will lie still on a table in a machine that takes images.
- Participants will have surgery to remove their tumor. Some will have surgery right away.
Some will have surgery 6 months later, after 2 follow-up appointments.
- Participants will have 4 follow-up visits in the first year after surgery. They will
have 2 visits the second year, then yearly visits for 3 years. At each follow-up visit,
they will have scans and blood tests.
Status | Terminated |
Enrollment | 4 |
Est. completion date | February 26, 2018 |
Est. primary completion date | August 22, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 99 Years |
Eligibility |
- INCLUSION CRITERIA: - An individual with an adrenal neoplasm less than 5 cm in size with biochemically confirmed evidence of hypercortisolism (2 out of 3: dexamethasone suppression test (DST) >3 mcgl/dL, elevated urine free cortisol, and/or morning adrenocorticotropic hormone (ACTH) <2.2 pmol/l) without overt clinical signs and symptoms. - Age greater than or equal to 18 years. - Adults must be able to understand and sign the informed consent document. - Patients must have laboratory and physical examination parameters within acceptable limits by standard of practice. EXCLUSION CRITERIA: - Biochemically and/or radiologically confirmed pheochromocytoma, hyperaldosteronism, or adrenocortical carcinoma. - Nonfunctioning adrenal neoplasm. - Pre-existing cancers and/or metastatic disease to the adrenal glands. - Pregnancy and/or lactation. - Lack of metabolic complications. - Imaging features worrisome for malignancy (heterogeneous tumor, presence of calcifications, necrosis, >10 Hounsfield units on an unenhanced computed tomography (CT) scan, and delayed washout of contrast). |
Country | Name | City | State |
---|---|---|---|
United States | National Institutes of Health Clinical Center, 9000 Rockville Pike | Bethesda | Maryland |
Lead Sponsor | Collaborator |
---|---|
National Cancer Institute (NCI) | Clinical Center Office of the Associates Director for Radiologic&Imaging Sciences, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
United States,
Chiodini I. Clinical review: Diagnosis and treatment of subclinical hypercortisolism. J Clin Endocrinol Metab. 2011 May;96(5):1223-36. doi: 10.1210/jc.2010-2722. Epub 2011 Mar 2. Review. — View Citation
Reincke M. Subclinical Cushing's syndrome. Endocrinol Metab Clin North Am. 2000 Mar;29(1):43-56. Review. — View Citation
Toniato A, Merante-Boschin I, Opocher G, Pelizzo MR, Schiavi F, Ballotta E. Surgical versus conservative management for subclinical Cushing syndrome in adrenal incidentalomas: a prospective randomized study. Ann Surg. 2009 Mar;249(3):388-91. doi: 10.1097/SLA.0b013e31819a47d2. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Proportion of Patients That Have Normalization and/or Improvement of Metabolic Complications After Adrenalectomy | Normalization and/or improvement of metabolic complications including hypertension, diabetes, osteoporosis, hypercholesterolemia and/or obesity after adrenalectomy is defined as 35% of patients who improve with surgery versus 5% who do not have surgery. | Assessed at 6 months | |
Primary | Count of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0) | Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned. | Date treatment consent signed to date off study, approximately 39 months and 27 days | |
Secondary | Proportion of Patients Who Are Found to Have Adrenal Cancer After Adrenalectomy | Patients who were tested for and found to have adrenal cancer after adrenalectomy. | Assessed at 6 months | |
Secondary | Proportion of Patients Who Were Diagnosed With Subclinical Hypercortisolism by Fluorodeoxyglucose (FDG) Positron Emission Tomography (PET)/Computed Tomography (CT) Scan | Proportion of patients who were diagnosed with subclinical hypercortisolism by FDG/PET/CT scan. | Assessed at 6 months | |
Secondary | To Determine the Optimal Diagnostic Test for Subclinical Hypercortisolism | An assessment of whether 1 mg dexamethasone suppression test, basal adrenocorticotropic hormone (ACTH), midnight salivary cortisol, or urinary free cortisol is the optimal test to diagnose patients with subclinical hypercortisolism. | Assessed at 6 months | |
Secondary | Proportion of Patients That Have Improvement in Quality of Life (QOL) After Adrenalectomy Compared to Medical Therapy | QOL questionnaires were provided to participants to assess well being pre and post operatively. Participants take a self-administered questionnaire to assess physical and mental health according to Cushing's Quality of Life Questionnaire. The score has a minimum of 12 and maximum of 60. A higher score indicates an improved quality of life. | Assessed at 6 months | |
Secondary | Proportion of Patients That Developed Deep Venous Thrombosis With Subclinical Hypercortisolism | Proportion of patients that developed deep venous thrombosis with subclinical hypercortisolism regardless of whether the participants received adrenalectomy or not. | Assessed at 6 months | |
Secondary | Correlation Between Dermal Thickness and Patients With Subclinical Hypercortisolism | A skin biopsy and skin ultrasound were done to measure the dermal layer of skin to look for a decrease in the thickness of skin as compared to normal values reported in the literature as measured in millimeters of thickness. Diagnostic sensitivity and changes in skin thickness were assessed. | Assessed at 6 months |
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