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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 is a clinical trial that has completed, run by National Heart, Lung, and Blood Institute (NHLBI). The registered enrollment target is 82 participants.

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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

Trial Details

FieldValue
Enrollment Target 82 participants
Start Date 2007-01-23
Est. Completion 2021-03-22

What the Registry Record Tells You About NCT00406445

The ClinicalTrials.gov registry entry for NCT00406445 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 82 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Heart, Lung, and Blood Institute (NHLBI), which has 501 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 0 interventions.

NCT00406445 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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