Clinical trial NCT01182909: Environmental and Genetic Determinants of Nasopharyngeal Carcinoma (NPC)
Official title: Far Eastern Memorial Hospital
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Nasopharyngeal Carcinoma
Keywords: 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
Lead sponsor: Far Eastern Memorial Hospital
Sponsor class: OTHER
Collaborators: name: National Taiwan University Hospital
First posted: 2010-08-17
Enrollment: 4000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
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

Brief summary: 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.


Eligibility 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Far Eastern Memorial Hospital
Study officials:
References: