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NCT00406445 · ClinicalTrials.gov registry record
Role of p53 Gene in Metabolism Regulation in Patients With Li-Fraumeni Syndrome
A clinical trial, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
- Completed
- Registry status
- 82
- Enrollment target
NCT00406445: Completed study, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
NCT00406445 is a clinical trial that has completed, run by National Heart, Lung, and Blood Institute (NHLBI). The registered enrollment target is 82 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00406445 has completed, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
- COMPLETED
- Registry status
- 82 participants
- Enrollment target
Study Summary
This study will examine metabolic and biological factors in people with Li-Fraumeni syndrome, a rare hereditary disorder that greatly increases a person's susceptibility to cancer. Patients have a mutation in the p53 tumor suppressor gene, which normally helps control cell growth. This gene may control metabolism as well as cancer susceptibility, and the study findings may help improve our understanding of not only cancer but also other conditions, such as cardiovascular function. Healthy normal volunteers and patients with the Li-Fraumeni syndrome and their family members may be eligible for this study. Candidates must be at least 18 years of age, in overall good health and cancer-free within 1 year of entering the study. Participants undergo the following procedures: * Blood tests for routine lab values and for research purposes. * ECG and echocardiogram (heart ultrasound) to evaluate heart structure and function. * Resting and exercise metabolic stress testing: The subject first relaxes in a chair wearing the facemask and then exercises on a stationary bicycle or treadmill while wearing the mask. This test uses the facemask to measure oxygen usage by the body to determine metabolic fitness. Electrodes are placed on the body to monitor the heart in an identical manner to a standard exercise stress test. * Magnetic resonance imaging of metabolism: The subject lies on a bed that slides into a large magnet (the MRI scanner) for up to 60 minutes. During scanning, the arm or leg muscles are stressed by inflating a blood pressure cuff and by exercising the limb for several minutes. Subjects may be asked to squeeze a rubber ball or exercise with a foot pedal. Immediately afterwards, the pressure in the cuff is released and remains deflated for 10 to 15 minutes. No more than three 5-minute episodes of blood flow stoppage are performed. * Standard MRI scan of exercised limb to determine muscle volume. * Brachial artery reactivity test to measure blood vessel function: Be
Primary Outcome
Because an interim analysis has confirmed our hypothesis, the aim of the primary endpoint has been achieved.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 82 participants |
| Start Date | 2007-01-23 |
| Est. Completion | 2021-03-22 |
What the finished NCT00406445 record still lists
NCT00406445 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 82 participants, a relatively small participant target.
The record links to 0 conditions, and to 0 interventions.
NCT00406445 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00406445 about?
NCT00406445 is a clinical study titled "Role of p53 Gene in Metabolism Regulation in Patients With Li-Fraumeni Syndrome". This study will examine metabolic and biological factors in people with Li-Fraumeni syndrome, a rare hereditary disorder that greatly increases a person's susceptibility to cancer. Patients have a mutation in the p53 tumor suppressor gene, which normally helps control cell growth. This gene may cont...
What is the current status of trial NCT00406445?
This trial is currently completed. The enrollment target is 82 participants. The study started on 2007-01-23. Estimated completion is 2021-03-22.
Who is sponsoring clinical trial NCT00406445?
This trial is sponsored by National Heart, Lung, and Blood Institute (NHLBI), which has 501 total clinical trials registered on ClinicalTrials.gov.
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