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NCT00032513 · ClinicalTrials.gov registry record

Genetic Studies of Chronic Active Epstein-Barr Disease

A clinical trial of Chronic Active Epstein-Barr Virus, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

Recruiting
Registry status
300
Enrollment target
1
Study location

NCT00032513: Recruiting study of Chronic Active Epstein-Barr Virus, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

NCT00032513 is a study of Chronic Active Epstein-Barr Virus that is actively recruiting participants, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 300 participants. The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00032513, a study of Chronic Active Epstein-Barr Virus, is actively recruiting participants, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

RECRUITING
Registry status
300 participants
Enrollment target
1
Study location

Study Summary

Epstein-Barr virus (EBV) is a member of the human herpes virus family that infects more than 95 percent of the U.S. population. Most infections occur in childhood and cause no symptoms; in adolescents and adults, EBV often causes infectious mononucleosis. It has also been associated with certain forms of cancer. Chronic Epstein-Barr virus (CAEBV) is a rare disease, primarily of children and young adults, that leads to life-threatening infections. This study seeks to identify genetic mutations responsible for CAEBV. A secondary goal is to learn more about the natural history of CAEBV. The study will examine blood and tissue samples from up to 50 patients (age 3 and above) with CAEBV and up to 150 of their relatives (age 1 and above). Autopsy samples may be included in the study. Up to 300 anonymous blood samples from the NIH Clinical Center Blood Transfusion Medicine will also be examined for comparison. No more than 450 milligrams (30 tablespoons) of blood per 8 weeks will be drawn from adult patients, and no more than 7 milliliters per kilogram of blood per 8 weeks will be drawn from patients under age 18. Local health care providers will refer patients to the study and will obtain the samples. Some patients may also be seen at the NIH Clinical Center. Those patients will have a full medical history and physical examination, along with chest X-ray, blood counts, blood chemistry, EBV serologies, and viral load. Other tests, such as CT scan or MRI, may be performed if medically indicated. Patients will be asked to undergo leukapheresis. In vitro tests on the blood or tissue samples will include analysis for proteins or genes that are involved in the immune response; cloning of portions of patient DNA; transformation of B cells with EBV; measurement of the ability of patient blood cells to kill EBV-infected cells; determination of lymphocyte subsets; and determination of antibodies to EBV or other herpes viruses. If a genetic cause for CAEBV is found, the investi

Primary Outcome

Provide insights into the immunologic control of EBV infections.

Study Locations (1)

Maryland

  • National Institutes of Health Clinical Center - Bethesda

Trial Details

FieldValue
Enrollment Target 300 participants
Start Date 2002-04-16

What NCT00032513 shows while recruiting

NCT00032513 is an observational study that tracks outcomes without assigning an intervention. The registered 300 participants enrollment target is mid-sized for trials with a published cap.

The record links to 1 condition, with Chronic Active Epstein-Barr Virus appearing as the primary indexed condition, and to 0 interventions.

NCT00032513 reports a single indexed study location in Maryland.

Frequently Asked Questions

What is clinical trial NCT00032513 about?

NCT00032513 is a clinical study titled "Genetic Studies of Chronic Active Epstein-Barr Disease". Epstein-Barr virus (EBV) is a member of the human herpes virus family that infects more than 95 percent of the U.S. population. Most infections occur in childhood and cause no symptoms; in adolescents and adults, EBV often causes infectious mononucleosis. It has also been associated with certain for...

What is the current status of trial NCT00032513?

This trial is currently recruiting. The enrollment target is 300 participants. The study started on 2002-04-16.

What conditions does trial NCT00032513 study?

This clinical trial studies the following conditions: Chronic Active Epstein-Barr Virus.

Who is sponsoring clinical trial NCT00032513?

This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00032513 being conducted?

This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Source: ClinicalTrials.gov NCT00032513, the US trial registry maintained by the National Library of Medicine. NCT00032513 (mid enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.