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NCT00070785
Protein Studies of the Epstein-Barr Virus in Ethnically Diverse Populations
trial in Epstein-Barr Virus Infections in 60 participants. Completed in 21 April 2008.
Quick facts
| Lead sponsor | National Institutes of Health Clinical Center (CC) |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 60 |
| Start date | 6 October 2003 |
| Estimated completion | 21 April 2008 |
| Sites | 1 location across United States |
Conditions studied
- Epstein-Barr Virus Infections — all drugs for Epstein-Barr Virus Infections →
Sponsor
National Institutes of Health Clinical Center (CC)
Who can join
18 and older, any sex, with Epstein-Barr Virus Infections. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This study will evaluate the ability of people of different ethnic backgrounds to develop immune responses against the Epstein-Barr virus (EBV). A common virus, EBV is present in 90 percent of healthy people and usually does not cause problems. Most people are infected in childhood, have no symptoms, and are unaware of their infection. People infected as adolescents or adults may develop infectious mononucleosis, which usually resolves completely. However, in immune suppressed people, like those who have had a transplant, EBV can cause fatal cancers. It can also cause certain cancers such as Burkitt's lymphoma, Hodgkin's lymphoma, and nasopharyngeal carcinoma in people who are not immune suppressed. Nasopharyngeal carcinoma is 100 times more common in people of Asian origin (particularly southern Chinese) compared with Caucasians. This difference may be the result of genetic, rather than environmental, factors. This study will examine whether the same proteins produced by EBV in the cancer cells react differently in people of different ethnic background in a way that could explain the differences in predisposition for this disease. Healthy normal volunteers 18 years of age and older of Caucasian or Chinese ancestry may be eligible for this study. Candidates of Chinese ancestry must be born in China (including Taiwan, Hong Kong, and Singapore, or be first generation offspring of parents born in these places). Participants will have a blood sample drawn and will undergo lymphapheresis - a procedure for collecting large numbers of white blood cells called lymphocytes. The blood sample is tested for blood counts and HLA type, a genetic marker of the immune system. HLA molecules help determine the way the body's immune cells respond to virus. HLA typing is similar to blood typing. Usually done to match stem cell or organ transplants, HLA testing may also be used to try to identify factors associated with an increased risk of certain diseases or conditions. HLA type is strongly associated with ethnic background. For lymphapheresis, blood is collected through a needle in an arm vein, similar to donating blood. The blood flows from the vein through a catheter (plastic tube) into a machine that separates it into its components by centrifugation (spinning). The white cells are removed and the rest of the blood (red cells, plasma and platelets) is returned to the body through a needle in the other arm. The procedure takes 2 to 3 hours. The collected white cells are used for research for this study, including the ability to react to EBV proteins, and are then destroyed.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT00070785
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT00070785 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by National Institutes of Health Clinical Center (CC)
- Last refreshed: 2 July 2017
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