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NCT02001051 · ClinicalTrials.gov registry record · Phase 2
Study of Adrenalectomy Versus Observation for Subclinical Hypercortisolism
A Phase 2 study, sponsored by National Cancer Institute (NCI).
- Terminated
- Registry status
- Phase 2
- Development phase
- 4
- Enrollment target
NCT02001051: Clinical Trial Phase 2 study, sponsored by National Cancer Institute (NCI).
NCT02001051 is a Phase 2 study that was terminated before completion, run by National Cancer Institute (NCI). The registered enrollment target is 4 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02001051, a Phase 2 study, was terminated before completion, sponsored by National Cancer Institute (NCI).
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 4 participants
- Enrollment target
Study 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.
Primary Outcome
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.
Interventions
- OTHER Observation
- PROCEDURE Adrenalectomy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4 participants |
| Start Date | 2013-11-27 |
| Est. Completion | 2018-02-26 |
| Phase | Phase 2 |
Why NCT02001051 stopped before completion
NCT02001051 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 4 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 2 interventions - of which Observation is the first listed.
NCT02001051 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02001051 about?
NCT02001051 is a clinical study titled "Study 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 subc...
What is the current status of trial NCT02001051?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 4 participants. The study started on 2013-11-27. Estimated completion is 2018-02-26.
What interventions are being tested in trial NCT02001051?
The interventions under investigation include: Observation (OTHER), Adrenalectomy (PROCEDURE).
Who is sponsoring clinical trial NCT02001051?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02001051's enrollment target sits among peer trials
4 2001st of 2000 the lowest of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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