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Study of Adrenalectomy Versus Observation for Subclinical Hypercortisolism

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ClinicalTrials.gov Identifier: NCT02001051
Recruitment Status : Active, not recruiting
First Posted : December 4, 2013
Last Update Posted : October 19, 2017
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Description
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 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 Design

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
Study Start Date : November 27, 2013
Estimated Primary Completion Date : July 1, 2019
Estimated Study Completion Date : July 1, 2020


Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

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

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

Eligibility Criteria

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: 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

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)
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
First Posted: December 4, 2013    Key Record Dates
Last Update Posted: October 19, 2017
Last Verified: September 6, 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