A Phase 2 interventional study of Adrenalectomy and Observation in Subclinical Hypercortisolism, Cushing Syndrome and Adrenal Neoplasm, sponsored by National Cancer Institute (NCI). Terminated at 1 site in United States. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2018-06-14.
Sponsored by National Cancer Institute (NCI) · Phase 2, Interventional, and Treatment
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Among 58 studies in Cushing Syndrome with a site in United States — 14 open to participants now, 17 under way, none of them phase 3. Cushing Syndrome · United States.
Among the 58 studies in Cushing Syndrome with a site in United States, this one is the 31st largest by enrollment of the 34 interventional ones that give a count, is one of 3 that started in 2013, is one of 17 in phase 2, and was the 25th registered.
123 studies on the registry are indexed under Cushing Syndrome; 42 are open to participants now.
Browse Cushing Syndrome studies →14 of the 58 studies in Cushing Syndrome with a site in United States are open now. Recruiting first, the newest first:
Mayo Clinic · Sites in United States
Ages 18+
RECORDATI GROUP · Sites in United States
Ages 18+
University of Texas Southwestern Medical Center · Sites in United States
Ages 18+
Mayo Clinic · Sites in United States
Ages 18+
Sparrow Pharmaceuticals · Sites in United States
Ages 18+
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 35 Cushing Syndrome studies recruiting now, 14 (40%) set no upper age limit and 10 (29%) stop at 75 or younger; 8 take children under 18; 7 take healthy volunteers.
This study: 18 Years to 99 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
58 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 5 · Phase 2 20 · Phase 3 8 · Phase 4 3
First in 1982; this study’s year is marked. 3 started in 2013.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 4 is below the median of 44 across 58 interventional studies indexed under Cushing Syndrome.
Median enrollment 35 across the 34 interventional studies, 206 across the 23 observational. Of the 38 that completed or were terminated, 15 (39%) have results posted.
This tab as a report to print or save as PDF → With an account.
27 of 58 have an industry lead sponsor. The 10 most frequent:
National Cancer Institute (NCI) is the lead sponsor of 3,556 studies on the registry; 336 are open to participants now.
Of its 412 completed or terminated interventional studies of FDA-regulated products, 374 (91%) have results posted.
National Cancer Institute (NCI) has 2 studies filed under Cushing Syndrome — fewer than ten, so there is no comparison to draw.
6 of the studies in Cushing Syndrome with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT03364803Memorial Sloan Kettering Cancer CenterCollecting Information About Treatment Results for Patients With Cushing's Syndrome | 2026-11-28 |
| NCT03604198Corcept TherapeuticsExtension Study to Evaluate the Safety of Long-Term Use of Relacorilant in Patients With Cushing Syndrome | 2026-12 |
| NCT07104812Mayo ClinicImpact of 1 mg Osilodrostat Therapy on Mild Autonomous Cortisol Secretion (MACS) | 2027-01 |
| NCT05382156RECORDATI GROUPNon-interventional Study on Osilodrostat in Patients With Endogenous Cushing's Syndrome | 2027-06 |
| NCT03708900RECORDATI GROUPPharmacokinetic (PK), Pharmacodynamic (PD) and Tolerability of Osilodrostat in Pediatric Patients With Cushing's Syndrome | 2027-07-21 |
Add all 6 to your calendar (.ics) → With an account.
Among the 58 studies in Cushing Syndrome with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
Background:
Objectives:
Eligibility:
Design:
Background:
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:
Design:
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
EXCLUSION CRITERIA:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
operative arm
Procedure: Adrenalectomy
delayed operative arm
Other: Observation
Surgery to remove tumor when enrolled in the protocol.
Observation for 6 months prior to surgery
Proportion of Patients That Have Normalization and/or Improvement of Metabolic Complications After Adrenalectomy
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.
Time frame: Assessed at 6 months
Count of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0)
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.
Time frame: Date treatment consent signed to date off study, approximately 39 months and 27 days
Proportion of Patients Who Are Found to Have Adrenal Cancer After Adrenalectomy
Patients who were tested for and found to have adrenal cancer after adrenalectomy.
Time frame: Assessed at 6 months
Proportion of Patients Who Were Diagnosed With Subclinical Hypercortisolism by Fluorodeoxyglucose (FDG) Positron Emission Tomography (PET)/Computed Tomography (CT) Scan
Proportion of patients who were diagnosed with subclinical hypercortisolism by FDG/PET/CT scan.
Time frame: Assessed at 6 months
To Determine the Optimal Diagnostic Test for Subclinical Hypercortisolism
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.
Time frame: Assessed at 6 months
Proportion of Patients That Have Improvement in Quality of Life (QOL) After Adrenalectomy Compared to Medical Therapy
QOL 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.
Time frame: Assessed at 6 months
Proportion of Patients That Developed Deep Venous Thrombosis With Subclinical Hypercortisolism
Proportion of patients that developed deep venous thrombosis with subclinical hypercortisolism regardless of whether the participants received adrenalectomy or not.
Time frame: Assessed at 6 months
Correlation Between Dermal Thickness and Patients With Subclinical Hypercortisolism
A 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.
Time frame: Assessed at 6 months
| Milestone | Operative Arm | Delayed Operative Arm Followed by Surgery |
|---|---|---|
| Started | 2 | 2 |
| Completed | 2 | 1 |
| Not completed | 0 | 1 |
| Withdrew: Deemed not eligible following enrollment | 0 | 1 |
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.
| proportion of participants | Operative Arm | Delayed Operative Arm |
|---|---|---|
| Proportion of Patients That Have Normalization and/or Improvement of Metabolic Complications After Adrenalectomy | 1 | 0 |
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.
| Participants | Operative Arm | Delayed Operative Arm |
|---|---|---|
| Count of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0) | 0 | 0 |
Patients who were tested for and found to have adrenal cancer after adrenalectomy.
| proportion of participants | Operative Arm | Delayed Operative Arm |
|---|---|---|
| Proportion of Patients Who Are Found to Have Adrenal Cancer After Adrenalectomy | 0 | 0 |
Proportion of patients who were diagnosed with subclinical hypercortisolism by FDG/PET/CT scan.
| proportion of participants | Operative Arm | Delayed Operative Arm |
|---|---|---|
| Proportion of Patients Who Were Diagnosed With Subclinical Hypercortisolism by Fluorodeoxyglucose (FDG) Positron Emission Tomography (PET)/Computed Tomography (CT) Scan | 1 | 1 |
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.
No measurements were reported for this outcome.
QOL 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.
| proportion of participants | Operative Arm | Delayed Operative Arm |
|---|---|---|
| Proportion of Patients That Have Improvement in Quality of Life (QOL) After Adrenalectomy Compared to Medical Therapy | 2 | 0 |
Proportion of patients that developed deep venous thrombosis with subclinical hypercortisolism regardless of whether the participants received adrenalectomy or not.
| proportion of participants | Operative Arm | Delayed Operative Arm |
|---|---|---|
| Proportion of Patients That Developed Deep Venous Thrombosis With Subclinical Hypercortisolism | 0 | 0 |
A 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.
| Participants | Operative Arm | Delayed Operative Arm |
|---|---|---|
| Correlation Between Dermal Thickness and Patients With Subclinical Hypercortisolism | 0 | 0 |
Collected over Date treatment consent signed to date off study, approximately 39 months and 27 days.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Operative Arm | 0/2 (0%) | 0/2 (0%) | 0/2 (0%) |
| Delayed Operative Arm | 0/2 (0%) | 0/2 (0%) | 0/2 (0%) |
| Age, Categorical(Participants) | Operative Arm | Delayed Operative Arm Followed by Surgery | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 2 | 2 | 4 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | Operative Arm | Delayed Operative Arm Followed by Surgery | Total |
|---|---|---|---|
| Mean | 48.56 ± 11.68 | 43.25 ± 12.09 | 45.91 ± 10.18 |
| Sex: Female, Male(Participants) | Operative Arm | Delayed Operative Arm Followed by Surgery | Total |
|---|---|---|---|
| Female | 1 | 1 | 2 |
| Male | 1 | 1 | 2 |
| Ethnicity (NIH/OMB)(Participants) | Operative Arm | Delayed Operative Arm Followed by Surgery | Total |
|---|---|---|---|
| Hispanic or Latino | 1 | 0 | 1 |
| Not Hispanic or Latino | 1 | 2 | 3 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Operative Arm | Delayed Operative Arm Followed by Surgery | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 1 | 1 |
| White | 2 | 1 | 3 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(Participants) | Operative Arm | Delayed Operative Arm Followed by Surgery | Total |
|---|---|---|---|
| United States | 2 | 2 | 4 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Undecided
Ran from Nov 2013 to primary completion in Aug 2017, 44 months.
Results were first posted in May 2018, 8 months after primary completion.
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National Cancer Institute (NCI) →