Study of Adrenalectomy Versus Observation for Subclinical Hypercortisolism

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.

Conditions

• Subclinical Hypercortisolism
• Cushing Syndrome
• Adrenal Neoplasm

Interventions

PROCEDURE

Adrenalectomy

Surgery to remove tumor when enrolled in the protocol.

OTHER

Observation

Observation for 6 months prior to surgery

Sponsors & Collaborators

• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

  collaborator NIH

• Clinical Center Office of the Associates Director for Radiologic&Imaging Sciences

  collaborator UNKNOWN

• National Cancer Institute (NCI)

  lead NIH

Principal Investigators

• Dhaval T Patel, M.D. · National Cancer Institute (NCI)

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

99 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2013-11-27

Primary Completion

2017-08-22

Completion

2018-02-26

Countries

• United States

Study Locations