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Study of Adrenalectomy Versus Observation for Subclinical Hypercortisolism

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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 7, 2017
Last verified: September 6, 2017
  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
Subclinical Hypercortisolism Cushing Syndrome Adrenal Neoplasm Procedure: Adrenalectomy Other: Observation Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Proportion of patients that have normalization and/or improvementof metabolic complications after adrenalectomy. [ Time Frame: 6 months ]

Secondary Outcome Measures:
  • Proportion of patients who are found to have adrenal cancer afteradrenalectomy. [ Time Frame: 6 months ]
  • Proportion of patients who were diagnosed with subclinicalhypercortisolism by FDG PET/CT scan [ Time Frame: 6 months ]
  • To determine the optimal diagnostic test for subclinical hypercortisolism. [ Time Frame: 6 months ]
  • Proportion of patients that have improvement in quality of life afteradrenalectomy compared to medical therapy. [ Time Frame: 6 months ]
  • Proportion of patients that developed deep venous thrombosiswith subclinical hypercortisolism [ Time Frame: 6 months ]
  • Correlation between dermal thickness and diagnostic of subclinical hypercortisolism [ Time Frame: 6 months ]

Enrollment: 4
Study Start Date: November 19, 2013
Estimated Study Completion Date: July 1, 2020
Estimated Primary Completion Date: July 1, 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1
operative arm
Procedure: Adrenalectomy
Surgery to remove tumor when enrolled in the protocol.
2
delayed operative arm
Other: Observation
Observation for 6 months prior to surgery

  Show Detailed Description

  Eligibility

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: DST >3 mcgl/dL, 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.

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

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)
  More Information

Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: 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 7, 2017

Keywords provided by National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) ):
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

ClinicalTrials.gov processed this record on September 19, 2017