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Study of Adrenalectomy Versus Observation for Subclinical Hypercortisolism

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by National Institutes of Health Clinical Center (CC)
Sponsor:
Collaborators:
CC-OADRIS
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )
ClinicalTrials.gov Identifier:
NCT02001051
First received: November 27, 2013
Last updated: September 10, 2014
Last verified: November 2013
  Purpose

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 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 Intervention Phase
Hypercortisolism
Cushing Syndrome
Procedure: Adrenalectomy
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized Control Trial of Adrenalectomy Versus Observation for Subclinical Hypercortisolism

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Primary Outcome Measures:
  • To determine whether adrenalectomy in patients diagnosed with subclinical hypercortisolism and a unilateral adrenal neoplasm results in normalization and/or improvement of metabolic complications. [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To determine the risk of primary adrenal malignancy in patients with subclinical hypercortisolism and adrenal mass less than 5 cm. [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • To determine whether FDG PET/CT scan is diagnostic of subclinical hypercortisolism. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • To determine the optimal diagnostic test for subclinical hypercortisolism. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • To determine whether patients show an improvement in quality of life after adrenalectomy compared to medical therapy. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • To determine whether patients have an increased risk of deep venous thrombosis with subclinical hypercortisolism, regardless of treatment. [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 66
Study Start Date: November 2013
Estimated Study Completion Date: October 2016
Estimated Primary Completion Date: October 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1
operative arm
Procedure: Adrenalectomy
Surgical removal of one or both adrenal glands
2
non-operative arm
Procedure: Adrenalectomy
Surgical removal of one or both adrenal glands

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
  • INCLUSION CRITERIA:
  • An individual with a unilateral adrenal neoplasm less than 5 cm in size with biochemically confirmed evidence of hypercortisolism (2 out of 3: DST > 3 mmol/l, elevated urine free cortisol, and/or morning 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 guidelines prior to surgery as assessed by preoperative anesthesia assessment.

EXCLUSION CRITERIA:

  • Biochemically and/or radiologically confirmed pheochromocytoma, hyperaldosteronoma, 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 CT scan, and delayed washout of contrast).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02001051

Contacts
Contact: Roxanne E Merkel (301) 402-4395 merkelre@mail.nih.gov
Contact: Electron Kebebew, M.D. (301) 496-5049 kebebewe@mail.nih.gov

Locations
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike Recruiting
Bethesda, Maryland, United States, 20892
Contact: Kaitlyn Chambers    301-402-4395    kaitlyn.chambers@nih.gov   
Contact: Roxanne Merkel    (301) 402-4395    merkelre@mail.nih.gov   
Sponsors and Collaborators
CC-OADRIS
Investigators
Principal Investigator: Electron Kebebew, M.D. National Cancer Institute (NCI)
  More Information

Additional Information:
Publications:
Responsible Party: National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )
ClinicalTrials.gov Identifier: NCT02001051     History of Changes
Other Study ID Numbers: 140021, 14-C-0021
Study First Received: November 27, 2013
Last Updated: September 10, 2014
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Unilateral Adrenal Neoplasm
Cushing Syndrome
Adrenal Incidentalomas

Additional relevant MeSH terms:
Syndrome
Cushing Syndrome
Adrenocortical Hyperfunction
Disease
Pathologic Processes
Adrenal Gland Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on September 18, 2014