Defining the Clinical Utility of EBV Antibody Screening to Identify Individuals Susceptible to Nasopharyngeal Carcinoma (NPC) Within High-Risk, Multiplex NPC Families

NCT00393224 | Terminated

• 2 other identifiers: 99990518705-C-N187
• Study Type: observational
• Target: 952
• Locations: 1 country
• Sites: 1

Brief Summary

In an effort to identify genetic factors linked to the development of nasopharyngeal cancer (NPC), the researchers identified and sampled 2,394 individuals from Taiwanese families in which two or more relatives had been diagnosed with NPC. Serum from these individuals was tested for three anti-Epstein-Barr virus (EPV) antibodies associated with elevated risk of NPC. Results indicate that apparently healthy individuals from high-risk families have a nearly threefold elevation in their EBV antibody prevalence compared with the general population. However, the clinical implications of this finding are not yet understood. To clarify the implications, the 2,394 unaffected individuals from the multiplex family study will be invited to participate in the current study. Approximately 1,600 individuals are expected to participate. Participants will have an ear, nose, and throat examination to determine if they have occult or symptomatic NPC. Their levels of EBV antibody at the time of initial recruitment will be correlated with NPC detection in the period between initial recruitment and the present study. Participants will also be asked to complete a brief risk factor questionnaire and to donate blood, saliva, a nasopharyngeal swab, nasopharyngeal tissue, and urine for future studies. Currently, no accepted clinical management protocol exists for screening unaffected members from families at high risk of NPC development. Results from this study have the potential to significantly impact the clinical management and follow-up of individuals with a family history of NPC.

Conditions

Nasopharyngeal Neoplasms

Keywords

Epidemiology; Nasopharyngeal Carcinoma; Genetic; Viruses; Cancer; NPC

Outcome Measures

Primary Outcomes (1)

• NPC

  NPC

  ongoing

Study Arms (1)

cohort

hospital based family cohort

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This is a hospital based family cohort

You may qualify if:

• The 2,394 unaffected family members who previously participated in the family study of nasopharyngeal carcinoma (NPC) in Taiwan between 1996 and 2004.

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

National Taiwan University

Taiwan, China

Location

Related Publications (3)

• Cohen JI. Epstein-Barr virus infection. N Engl J Med. 2000 Aug 17;343(7):481-92. doi: 10.1056/NEJM200008173430707. No abstract available.

  PMID: 10944566 BACKGROUND

• Hsu JL, Glaser SL. Epstein-barr virus-associated malignancies: epidemiologic patterns and etiologic implications. Crit Rev Oncol Hematol. 2000 Apr;34(1):27-53. doi: 10.1016/s1040-8428(00)00046-9.

  PMID: 10781747 BACKGROUND

• Zeng Y, Zhang LG, Wu YC, Huang YS, Huang NQ, Li JY, Wang YB, Jiang MK, Fang Z, Meng NN. Prospective studies on nasopharyngeal carcinoma in Epstein-Barr virus IgA/VCA antibody-positive persons in Wuzhou City, China. Int J Cancer. 1985 Nov 15;36(5):545-7. doi: 10.1002/ijc.2910360505.

  PMID: 4055129 BACKGROUND

MeSH Terms

Conditions

Nasopharyngeal Neoplasms; Nasopharyngeal Carcinoma; Virus Diseases; Neoplasms

Condition Hierarchy (Ancestors)

Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Infections

Study Officials

• Allan Hildesheim, Ph.D.

  National Cancer Institute (NCI)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 26, 2006
• First Posted: October 27, 2006
• Study Start: July 5, 2005
• Primary Completion: June 2, 2020
• Study Completion: June 2, 2020
• Last Updated: June 4, 2020

Record last verified: 2020-06

Locations

CN (1)