Trial Outcomes & Findings for Study of Adrenalectomy Versus Observation for Subclinical Hypercortisolism (NCT NCT02001051)
NCT ID: NCT02001051
Last Updated: 2018-06-14
Results Overview
Normalization and/or improvement of metabolic complications including hypertension, diabetes, osteoporosis, hypercholesterolemia and/or obesity after adrenalectomy is defined as 35% of patients who improve with surgery versus 5% who do not have surgery.
TERMINATED
PHASE2
4 participants
Assessed at 6 months
2018-06-14
Participant Flow
One participant was enrolled to the delayed operative arm but did not complete. The participant did not have biochemical evidence of subclinical Cushing's and therefore was not eligible.
Participant milestones
| Measure |
Operative Arm
operative arm
Adrenalectomy: Surgery to remove tumor when enrolled in the protocol.
|
Delayed Operative Arm Followed by Surgery
delayed operative arm
Observation: Observation for 6 months prior to surgery
|
|---|---|---|
|
Overall Study
STARTED
|
2
|
2
|
|
Overall Study
COMPLETED
|
2
|
1
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
Operative Arm
operative arm
Adrenalectomy: Surgery to remove tumor when enrolled in the protocol.
|
Delayed Operative Arm Followed by Surgery
delayed operative arm
Observation: Observation for 6 months prior to surgery
|
|---|---|---|
|
Overall Study
Deemed not eligible following enrollment
|
0
|
1
|
Baseline Characteristics
Study of Adrenalectomy Versus Observation for Subclinical Hypercortisolism
Baseline characteristics by cohort
| Measure |
Operative Arm
n=2 Participants
operative arm
Adrenalectomy: Surgery to remove tumor when enrolled in the protocol.
|
Delayed Operative Arm Followed by Surgery
n=2 Participants
delayed operative arm
Observation: Observation for 6 months prior to surgery
|
Total
n=4 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
48.56 years
STANDARD_DEVIATION 11.68 • n=5 Participants
|
43.25 years
STANDARD_DEVIATION 12.09 • n=7 Participants
|
45.91 years
STANDARD_DEVIATION 10.18 • n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Assessed at 6 monthsNormalization and/or improvement of metabolic complications including hypertension, diabetes, osteoporosis, hypercholesterolemia and/or obesity after adrenalectomy is defined as 35% of patients who improve with surgery versus 5% who do not have surgery.
Outcome measures
| Measure |
Operative Arm
n=2 Participants
operative arm
Adrenalectomy: Surgery to remove tumor when enrolled in the protocol.
|
Delayed Operative Arm
n=1 Participants
delayed operative arm
Observation: Observation for 6 months prior to surgery
|
|---|---|---|
|
Proportion of Patients That Have Normalization and/or Improvement of Metabolic Complications After Adrenalectomy
|
1 proportion of participants
|
0 proportion of participants
|
PRIMARY outcome
Timeframe: Date treatment consent signed to date off study, approximately 39 months and 27 daysPopulation: No toxicities were experienced by any participants on this trial.
Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.
Outcome measures
| Measure |
Operative Arm
n=2 Participants
operative arm
Adrenalectomy: Surgery to remove tumor when enrolled in the protocol.
|
Delayed Operative Arm
n=1 Participants
delayed operative arm
Observation: Observation for 6 months prior to surgery
|
|---|---|---|
|
Count of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0)
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Assessed at 6 monthsPatients who were tested for and found to have adrenal cancer after adrenalectomy.
Outcome measures
| Measure |
Operative Arm
n=2 Participants
operative arm
Adrenalectomy: Surgery to remove tumor when enrolled in the protocol.
|
Delayed Operative Arm
n=1 Participants
delayed operative arm
Observation: Observation for 6 months prior to surgery
|
|---|---|---|
|
Proportion of Patients Who Are Found to Have Adrenal Cancer After Adrenalectomy
|
0 proportion of participants
|
0 proportion of participants
|
SECONDARY outcome
Timeframe: Assessed at 6 monthsProportion of patients who were diagnosed with subclinical hypercortisolism by FDG/PET/CT scan.
Outcome measures
| Measure |
Operative Arm
n=2 Participants
operative arm
Adrenalectomy: Surgery to remove tumor when enrolled in the protocol.
|
Delayed Operative Arm
n=1 Participants
delayed operative arm
Observation: Observation for 6 months prior to surgery
|
|---|---|---|
|
Proportion of Patients Who Were Diagnosed With Subclinical Hypercortisolism by Fluorodeoxyglucose (FDG) Positron Emission Tomography (PET)/Computed Tomography (CT) Scan
|
1 proportion of participants
|
1 proportion of participants
|
SECONDARY outcome
Timeframe: Assessed at 6 monthsPopulation: This outcome measure was not done. Data was collected and not analyzed because we were not able to determine the optimal test since we only had four patients enrolled, and three patients on study (e.g. low accrual). Therefore, we couldn't do a head to head comparison calculating the sensitivity and specificity.
An assessment of whether 1 mg dexamethasone suppression test, basal adrenocorticotropic hormone (ACTH), midnight salivary cortisol, or urinary free cortisol is the optimal test to diagnose patients with subclinical hypercortisolism.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Assessed at 6 monthsQOL questionnaires were provided to participants to assess well being pre and post operatively. Participants take a self-administered questionnaire to assess physical and mental health according to Cushing's Quality of Life Questionnaire. The score has a minimum of 12 and maximum of 60. A higher score indicates an improved quality of life.
Outcome measures
| Measure |
Operative Arm
n=2 Participants
operative arm
Adrenalectomy: Surgery to remove tumor when enrolled in the protocol.
|
Delayed Operative Arm
n=1 Participants
delayed operative arm
Observation: Observation for 6 months prior to surgery
|
|---|---|---|
|
Proportion of Patients That Have Improvement in Quality of Life (QOL) After Adrenalectomy Compared to Medical Therapy
|
2 proportion of participants
|
0 proportion of participants
|
SECONDARY outcome
Timeframe: Assessed at 6 monthsProportion of patients that developed deep venous thrombosis with subclinical hypercortisolism regardless of whether the participants received adrenalectomy or not.
Outcome measures
| Measure |
Operative Arm
n=2 Participants
operative arm
Adrenalectomy: Surgery to remove tumor when enrolled in the protocol.
|
Delayed Operative Arm
n=1 Participants
delayed operative arm
Observation: Observation for 6 months prior to surgery
|
|---|---|---|
|
Proportion of Patients That Developed Deep Venous Thrombosis With Subclinical Hypercortisolism
|
0 proportion of participants
|
0 proportion of participants
|
SECONDARY outcome
Timeframe: Assessed at 6 monthsA skin biopsy and skin ultrasound were done to measure the dermal layer of skin to look for a decrease in the thickness of skin as compared to normal values reported in the literature as measured in millimeters of thickness. Diagnostic sensitivity and changes in skin thickness were assessed.
Outcome measures
| Measure |
Operative Arm
n=2 Participants
operative arm
Adrenalectomy: Surgery to remove tumor when enrolled in the protocol.
|
Delayed Operative Arm
n=1 Participants
delayed operative arm
Observation: Observation for 6 months prior to surgery
|
|---|---|---|
|
Correlation Between Dermal Thickness and Patients With Subclinical Hypercortisolism
|
0 Participants
|
0 Participants
|
Adverse Events
Operative Arm
Delayed Operative Arm
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place