Environmental and Genetic Determinants of Nasopharyngeal Carcinoma (NPC)

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2011 by Far Eastern Memorial Hospital
Sponsor:
Collaborator:
National Taiwan University Hospital
Information provided by (Responsible Party):
Li-Jen Liao, Far Eastern Memorial Hospital
ClinicalTrials.gov Identifier:
NCT01182909
First received: August 15, 2010
Last updated: September 16, 2011
Last verified: September 2011
  Purpose

Nasopharyngeal carcinoma (NPC) is one of the most common malignant tumors in southern China and Southeast Asia. While infection with Epstein-Barr Virus (EBV) is believed to be necessary for the development of NPC, non-viral environmental factors have also been implicated to increase the risk of NPC including consumption of salted fish and other nitrosamine containing preserved foods, formaldehyde and wood dust exposure, and cigarette smoking. In addition to environmental factors, it is widely accepted that genetic susceptibility also plays an important role in the pathogenesis of NPC. Polymorphisms in genes involved in nitrosamine metabolism and DNA repair have been suggested to be associated with NPC risk, and various chromosomal regions linked to NPC development have been reported. These associations highlight the role of both environmental and genomic components in the etiology of NPC.

There is a longstanding history of international collaborative studies to elucidate the role of environmental and genetic factors associated with NPC between investigators in Taiwan and the USA. A case-control study (375 cases; 327 controls) was conducted in the early 1990s, and a large multiplex family study that was completed in 2006 (358 families; 3,216 individuals). Results from these studies have provided some of the most comprehensive epidemiological evidence regarding factors linked to NPC development to date.

As a next logical step, the opportunity now exists to undertake a genome-wide association study of NPC in Taiwan with carefully collected environmental exposure data to systematically examine environmental and genetic factors associated with NPC, and to evaluate gene-gene and gene-environment interactions. The investigators propose a case-control study of 2000 NPC cases (both retrospective [n=800] and prospective [n=1,200]) and 2,000 age-gender-matched hospital controls in northern Taiwan. The study objectives are to: 1) evaluate putative environmental exposures and NPC; 2) assess the effect of genetic factors, including both single nucleotide polymorphism and copy number variation through analysis of both main effect and gene-gene interaction; 3) investigate gene-environment interactions by testing for interactions between significant genome-wide genetic variations and EBV and other identified environmental risk factors; and 4) examine the natural history of EBV infection.


Condition
Nasopharyngeal Carcinoma

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Far Eastern Memorial Hospital

Resource links provided by NLM:


Further study details as provided by Far Eastern Memorial Hospital:

Estimated Enrollment: 4000
Study Start Date: August 2010
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

We propose a case-control study of 2000 NPC cases (both retrospective [n=800] and prospective [n=1,200]) and 2,000 age-gender-matched hospital controls in northern Taiwan

Criteria

Inclusion Criteria:

  • Patients diagnosed with NPC

Exclusion Criteria:

  • Case group and control group younger than 18 age. Control group, the reasons for hospitalization for the EB virus-related disease
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01182909

Locations
Taiwan
Far Eastern Memorial Hospital Recruiting
Taipei, Taiwan
Contact: Liao Li-Jen    (02)8966-7000 ext 2124    deniro@mail2000.com.tw   
Sponsors and Collaborators
Far Eastern Memorial Hospital
National Taiwan University Hospital
  More Information

No publications provided

Responsible Party: Li-Jen Liao, Department of Otolaryngology, Far Eastern Memorial Hospital
ClinicalTrials.gov Identifier: NCT01182909     History of Changes
Other Study ID Numbers: 099046-F
Study First Received: August 15, 2010
Last Updated: September 16, 2011
Health Authority: Taiwan: Department of Health

Keywords provided by Far Eastern Memorial Hospital:
NPC
Environmental and Genetic
evaluate putative environmental exposures and NPC
assess the effect of genetic factors
investigate gene-environment interactions
examine the natural history of EBV infection

Additional relevant MeSH terms:
Pharyngeal Diseases
Carcinoma
Nasopharyngeal Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Nasopharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases

ClinicalTrials.gov processed this record on July 20, 2014