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Study of Adrenalectomy Versus Observation for Subclinical Hypercortisolism

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ClinicalTrials.gov Identifier: NCT02001051
Recruitment Status : Terminated (Study was closed due to low accrual.)
First Posted : December 4, 2013
Results First Posted : May 8, 2018
Last Update Posted : May 8, 2018
Sponsor:
Collaborators:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
CC-OADRIS
Information provided by (Responsible Party):
Dhaval Patel, M.D., National Institutes of Health Clinical Center (CC)

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Subclinical Hypercortisolism Cushing Syndrome Adrenal Neoplasm Procedure: Adrenalectomy Other: Observation Phase 2

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Control Trial of Adrenalectomy Versus Observation for Subclinical Hypercortisolism
Actual Study Start Date : November 27, 2013
Actual Primary Completion Date : August 22, 2017
Actual Study Completion Date : February 26, 2018


Arm Intervention/treatment
Operative Arm
operative arm
Procedure: Adrenalectomy
Surgery to remove tumor when enrolled in the protocol.
Delayed Operative Arm
delayed operative arm
Other: Observation
Observation for 6 months prior to surgery



Primary Outcome Measures :
  1. Proportion of Patients That Have Normalization and/or Improvement of Metabolic Complications After Adrenalectomy [ Time Frame: 6 months ]
    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.

  2. Count of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0) [ Time Frame: Date treatment consent signed to date off study, approximately 39 months and 27 days ]
    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.


Secondary Outcome Measures :
  1. Proportion of Patients Who Are Found to Have Adrenal Cancer After Adrenalectomy [ Time Frame: 6 months ]
    Patients who were tested for and found to have adrenal cancer after adrenalectomy.

  2. Proportion of Patients Who Were Diagnosed With Subclinical Hypercortisolism by Fluorodeoxyglucose (FDG) Positron Emission Tomography (PET)/Computed Tomography (CT) Scan [ Time Frame: 6 months ]
    Proportion of patients who were diagnosed with subclinical hypercortisolism by FDG/PET/CT scan.

  3. To Determine the Optimal Diagnostic Test for Subclinical Hypercortisolism [ Time Frame: 6 months ]
    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.

  4. Proportion of Patients That Have Improvement in Quality of Life (QOL) After Adrenalectomy Compared to Medical Therapy [ Time Frame: 6 months ]
    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.

  5. Proportion of Patients That Developed Deep Venous Thrombosis With Subclinical Hypercortisolism [ Time Frame: 6 months ]
    Proportion of patients that developed deep venous thrombosis with subclinical hypercortisolism regardless of whether the participants received adrenalectomy or not.

  6. Correlation Between Dermal Thickness and Patients With Subclinical Hypercortisolism [ Time Frame: 6 months ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
  • 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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02001051


Locations
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
National Cancer Institute (NCI)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
CC-OADRIS
Investigators
Principal Investigator: Dhaval T Patel, M.D. National Cancer Institute (NCI)
  Study Documents (Full-Text)

Documents provided by Dhaval Patel, M.D., National Institutes of Health Clinical Center (CC):

Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dhaval Patel, M.D., Principal Investigator, National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier: NCT02001051     History of Changes
Other Study ID Numbers: 140021
14-C-0021
First Posted: December 4, 2013    Key Record Dates
Results First Posted: May 8, 2018
Last Update Posted: May 8, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Dhaval Patel, M.D., National Institutes of Health Clinical Center (CC):
Diabetes, Hypertension, Hypercholesterolemia, Obesity, and Osteoporosis.
Nonoperative and Operative Management
Adrenal Incidentalomas
Excess of Cortisol

Additional relevant MeSH terms:
Cushing Syndrome
Adrenocortical Hyperfunction
Adrenal Gland Neoplasms
Adrenal Gland Diseases
Endocrine System Diseases
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms