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Environmental and Genetic Determinants of Nasopharyngeal Carcinoma (NPC)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2011 by Li-Jen Liao, Far Eastern Memorial Hospital.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01182909
First Posted: August 17, 2010
Last Update Posted: September 19, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Taiwan University Hospital
Information provided by (Responsible Party):
Li-Jen Liao, Far Eastern Memorial Hospital
  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 Li-Jen Liao, 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Submitted: August 15, 2010
First Posted: August 17, 2010
Last Update Posted: September 19, 2011
Last Verified: September 2011

Keywords provided by Li-Jen Liao, 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:
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
Pharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases