Study of Adrenalectomy Versus Observation for Subclinical Hypercortisolism
| Status: | Terminated |
|---|---|
| Conditions: | Cancer, Endocrine |
| Therapuetic Areas: | Endocrinology, Oncology |
| Healthy: | No |
| Age Range: | 18 - 99 |
| Updated: | 6/16/2018 |
| Start Date: | November 27, 2013 |
| End Date: | February 26, 2018 |
Randomized Control Trial of Adrenalectomy Versus Observation for Subclinical Hypercortisolism
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.
- 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.
Background:
- Adrenal incidentalomas are common and found in approximately 4-7% of the population.
- About 0.6 to 25% of patients with an adrenal incidentaloma are found to have subclinical
hypercortisolism: 2.3% develop subclinical hypercortisolism during follow up and 0.6%
develop clinical hypercortisolism during follow up.
- Subclinical hypercortisolism is defined as biochemical excess of cortisol without signs
and symptoms of overt hypercortisolism but may be associated with metabolic
complications or disease progression and malignancy.
- Overt signs and symptoms of hypercortisolism include facial plethora, easy bruising,
violaceous striae, and proximal muscle weakness.
- Several studies suggest that subclinical hypercortisolism may lead to long term
consequences such as diabetes, hypertension, hypercholesterolemia, obesity, and
osteoporosis.
- Thus, patients with subclinical hypercortisolism may benefit from operative intervention
to halt or reverse metabolic complications associated with the disease and the risk of
malignant progression.
- The optimal management of patients with subclinical hypercortisolism and adrenal
incidentalomas is controversial and no large randomized trial has been conducted.
- We hypothesize that operative treatment would reduce the risk of long term complications
of subclinical hypercortisolism and malignant progression, and propose a prospective
randomized trial comparing nonoperative and operative management of subclinical
hypercortisolism in patients with an adrenal neoplasm.
Objectives:
Primary Endpoints:
-To determine whether unilateral adrenalectomy in patients diagnosed with subclinical
hypercortisolism and adrenal neoplasm results in normalization and/or improvement of
hypertension as assessed by reduction in pharmacotherapy and/or normalization of blood
pressure (systolic pressure <=140 and diastolic pressure <=90), diabetes as assessed by
reduction or elimination of pharmacotherapy and/or improvement in A1C to <6.5%, osteoporosis
by increase in bone formation markers indicative of increased bone formation,
hypercholesterolemia as assessed by a reduction or elimination of pharmacotherapy and/or
reduction in low density lipoprotein (LDL) levels to risk-stratified goal levels as defined
by Adult Treatment Panel III (ATP III), and/or overweight or obesity as assessed by a 10
percent reduction in weight at 6 months.
Eligibility:
- 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 adrenocorticotrophic 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 based on standard clinical practice.
Design:
- Prospective randomized study comparing adrenalectomy versus observation.
- Patients assigned to the operative arm will undergo adrenalectomy and then followed
postoperatively for normalization and/or improvement of metabolic complications
associated with hypercortisolism and histologic examination of the resected tumor.
- Patients assigned to the non-operative arm will be monitored for possible complications
associated with hypercortisolism for six months, at which point they will cross-over to
the operative intervention arm.
- Patients with bilateral adrenal neoplasms will have the larger adrenal neoplasm used as
the primary lesion responsible for subclinical hypercortisolism.
- Demographic, clinical, laboratory and pathologic data will be collected for each patient
participant. Data will be securely stored in a computerized database.
- Patients will have biochemical testing to determine if their adrenal neoplasm is
functioning or nonfunctioning.
- Projected accrual will be 15 to 20 patients per year for a total of 5 years. Thus, we
anticipate accruing 62 patients on this protocol.
- Adrenal incidentalomas are common and found in approximately 4-7% of the population.
- About 0.6 to 25% of patients with an adrenal incidentaloma are found to have subclinical
hypercortisolism: 2.3% develop subclinical hypercortisolism during follow up and 0.6%
develop clinical hypercortisolism during follow up.
- Subclinical hypercortisolism is defined as biochemical excess of cortisol without signs
and symptoms of overt hypercortisolism but may be associated with metabolic
complications or disease progression and malignancy.
- Overt signs and symptoms of hypercortisolism include facial plethora, easy bruising,
violaceous striae, and proximal muscle weakness.
- Several studies suggest that subclinical hypercortisolism may lead to long term
consequences such as diabetes, hypertension, hypercholesterolemia, obesity, and
osteoporosis.
- Thus, patients with subclinical hypercortisolism may benefit from operative intervention
to halt or reverse metabolic complications associated with the disease and the risk of
malignant progression.
- The optimal management of patients with subclinical hypercortisolism and adrenal
incidentalomas is controversial and no large randomized trial has been conducted.
- We hypothesize that operative treatment would reduce the risk of long term complications
of subclinical hypercortisolism and malignant progression, and propose a prospective
randomized trial comparing nonoperative and operative management of subclinical
hypercortisolism in patients with an adrenal neoplasm.
Objectives:
Primary Endpoints:
-To determine whether unilateral adrenalectomy in patients diagnosed with subclinical
hypercortisolism and adrenal neoplasm results in normalization and/or improvement of
hypertension as assessed by reduction in pharmacotherapy and/or normalization of blood
pressure (systolic pressure <=140 and diastolic pressure <=90), diabetes as assessed by
reduction or elimination of pharmacotherapy and/or improvement in A1C to <6.5%, osteoporosis
by increase in bone formation markers indicative of increased bone formation,
hypercholesterolemia as assessed by a reduction or elimination of pharmacotherapy and/or
reduction in low density lipoprotein (LDL) levels to risk-stratified goal levels as defined
by Adult Treatment Panel III (ATP III), and/or overweight or obesity as assessed by a 10
percent reduction in weight at 6 months.
Eligibility:
- 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 adrenocorticotrophic 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 based on standard clinical practice.
Design:
- Prospective randomized study comparing adrenalectomy versus observation.
- Patients assigned to the operative arm will undergo adrenalectomy and then followed
postoperatively for normalization and/or improvement of metabolic complications
associated with hypercortisolism and histologic examination of the resected tumor.
- Patients assigned to the non-operative arm will be monitored for possible complications
associated with hypercortisolism for six months, at which point they will cross-over to
the operative intervention arm.
- Patients with bilateral adrenal neoplasms will have the larger adrenal neoplasm used as
the primary lesion responsible for subclinical hypercortisolism.
- Demographic, clinical, laboratory and pathologic data will be collected for each patient
participant. Data will be securely stored in a computerized database.
- Patients will have biochemical testing to determine if their adrenal neoplasm is
functioning or nonfunctioning.
- Projected accrual will be 15 to 20 patients per year for a total of 5 years. Thus, we
anticipate accruing 62 patients on this protocol.
- 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).
We found this trial at
1
site
9000 Rockville Pike
Bethesda, Maryland 20892
Bethesda, Maryland 20892
Phone: 301-402-4395
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