NCT00341146

Brief Summary

The objective of this study is to characterize genes associated either with susceptibility or resistance to the development nasopharyngeal carcinoma (NPC) in a Chinese population where the incidence of NPC is as high as 50 in 100,000. NPC has been and remains a unique model of human malignancy for understanding a multi-step carcinogenic process involving a ubiquitous virus (Epstein-Barr virus), environmental carcinogens, and an NPC susceptibility gene. Up to 95% of all NPC patients at early or late stage of the disease have IgA antibodies directed to the EBV virus VCA (viral capsid antigen). Environmental factors have also been implicated as significant risk factors in the development of NPC. In addition, certain alleles in HLA genes have shown associations with NPC, perhaps in concert with a family of T-cell receptor genes (TCR). Other data suggest that a microsatellite marker on Chromosome 6 may be associated with an NPC-disease associated gene.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6,490

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2001

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2001

Completed
5.2 years until next milestone

First Submitted

Initial submission to the registry

June 19, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 21, 2006

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 20, 2006

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 20, 2006

Completed
Last Updated

June 16, 2020

Status Verified

June 1, 2020

Enrollment Period

5.4 years

First QC Date

June 19, 2006

Last Update Submit

June 15, 2020

Conditions

Keywords

CancerCatonese ChineseGenetic PredispositionGenotypingTriad analysisNasopharyngeal CancerNPC

Outcome Measures

Primary Outcomes (1)

  • Collection from 9100 participants

    DNA Genotyping

    2006

Eligibility Criteria

Age7 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Chinese population with a high incidence of NPC

You may qualify if:

  • Individuals must meet the following eligibility criteria to be entered into the NPC study.
  • Cohort A: Proband: NPC positive (stage III or IV), age less than 50 at time of NPC diagnosis, and EBV/IgA/VCA positive. Spouse of Proband. Child of proband and of spouse (or a parent of the proband)
  • Cohort B: EBV/IgA/VCA positive 12 years ago and NPC negative. Spouse of proband. Child of proband and of spouse (or a parent of the proband).

You may not qualify if:

  • Persons with any of the following will be excluded from the study.
  • Persons who are unwilling or unable to given informed consent, or whose spouse and child(ren) (or parent) are willing to participate and give informed consent/assent.
  • Persons with no living spouse of child(ren)/parent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute for Viral Disease Control & Prevention

Beijing, China

Location

Related Publications (2)

  • O'Brien SJ, Nelson GW, Winkler CA, Smith MW. Polygenic and multifactorial disease gene association in man: Lessons from AIDS. Annu Rev Genet. 2000;34:563-591. doi: 10.1146/annurev.genet.34.1.563.

    PMID: 11092839BACKGROUND
  • Zeng Y. Seroepidemiological studies on nasopharyngeal carcinoma in China. Adv Cancer Res. 1985;44:121-38. doi: 10.1016/s0065-230x(08)60027-5. No abstract available.

    PMID: 2994402BACKGROUND

MeSH Terms

Conditions

Nasopharyngeal CarcinomaNeoplasmsGenetic Predisposition to DiseaseNasopharyngeal Neoplasms

Condition Hierarchy (Ancestors)

CarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypePharyngeal NeoplasmsOtorhinolaryngologic NeoplasmsHead and Neck NeoplasmsNeoplasms by SiteNasopharyngeal DiseasesPharyngeal DiseasesStomatognathic DiseasesOtorhinolaryngologic DiseasesDisease SusceptibilityDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Daniel W McVicar, Ph.D.

    National Cancer Institute (NCI)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
FAMILY BASED
Time Perspective
CROSS SECTIONAL
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 19, 2006

First Posted

June 21, 2006

Study Start

April 1, 2001

Primary Completion

August 20, 2006

Study Completion

September 20, 2006

Last Updated

June 16, 2020

Record last verified: 2020-06

Locations