Nasopharyngeal Neoplasms Clinical Trial
Official title:
Environmental and Genetic Determinants of NPC
Background:
- Nasopharyngeal carcinoma (NPC) a common malignant tumor in southern China and Southeast
Asia. Infection with Epstein-Barr virus is believed to be necessary for the development of
NPC; non-viral environmental factors, such as dietary consumption of nitrosamines, cigarette
smoking, betel nut chewing, wood dust exposure and possibly exposure to formaldehyde, have
been implicated in the disease. Genetic susceptibility may also play an important role in the
development of NPC. However, more information is needed on the connections between genetic
and environmental factors in NPC, particularly in areas where the cancer risk appears to be
greatest.
Objectives:
- To examine the main effects of genetic factors and environmental exposures (e.g., cigarette
smoking, betel nut chewing, formaldehyde, wood dust) on nasopharyngeal carcinoma risk.
Eligibility:
- Cases: Individuals at least 21 years of age who have been diagnosed with NPC at one of
the participating hospitals and have been residents of northern Taiwan for at least 6
months.
- Controls: Hospital patients with diseases other than NPC at least 21 years of age,
matched to NPC patients based on hospital, age at diagnosis, gender, and ethnicity.
Design:
- This study involves a risk factor interview, medical record abstraction and biological
sample collection.
- Participants will respond to interview questions about their lifestyle and risk factors
thought to be involved in NPC development.
- All participants will provide blood and saliva samples for study. Participants who have
been diagnosed with NPC will also provide consent to allow researchers to study tissue
samples taken during tumor biopsies or surgeries.
- Treatment will not be provided as part of this protocol.
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 in the
carcinogenesis of NPC including consumption of salted fish and other nitrosamine containing
preserved foods, formaldehyde and wood dust exposure, cigarette smoking, and betel nut
chewing. In addition to environmental factors, it is widely accepted that genetic
susceptibility plays an important role in the pathogenesis of NPC. Polymorphisms in genes
involved in antigen presentation, 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. Two recently completed NPC GWAS have reported that the strongest evidence
for disease association is observed for SNPs located on the 3.6 Mb Major Histocompatibility
Complex (MHC) region on chromosome 6p21 where human leukocyte antigen (HLA) genes are
located. These associations highlight the role of both environmental exposures and genomic
variation in the etiology of NPC. However, the specific role of EBV on NPC pathogenesis is
not completely understood and studies to date have had difficulty pinpointing the specific
genetic factors involved in NPC pathogenesis due to the complexity of the MHC region and
limited sample size of candidate gene studies.
DCEG investigators and their Taiwan colleagues have a longstanding history of studies to
elucidate the role of environmental and genetic factors associated with NPC. A case-control
study (375 cases; 327 controls) was conducted in the early 1990s and was followed by a large
multiplex family study that was completed in 2006 (358 families; 3,216 individuals). Results
from these studies have provided a substantial portion of the epidemiological evidence
regarding factors linked to NPC development to date.
At this time, we propose a new case-control study in Taiwan designed to 1) comprehensively
evaluate environmental risk factors for NPC; 2) systematically evaluate genetic risk factors
for NPC for which previous GWAS and candidate-gene studies have suggested an association; and
3) explore gene-gene and gene-environment interactions for strong main effects identified in
our study. In total, up to 2000 cases and 2000 controls are expected to be recruited from
five participating hospitals in Northern Taiwan. Cases will consist of 550 incident cases
ascertained retrospectively and 1350 incident cases ascertained prospectively. Controls will
be hospital based; they will be frequency matched (1:1) to cases on age, gender and
ethnicity, and will exclude individuals referred to the participating hospitals due to
conditions associated with known NPC risk factors.
This project is a collaborative effort between investigators in Taiwan and at the NCI.
Investigators in Taiwan will fund the field recruitment and data collection effort. Results
from this study have the potential to further clarify currently controversial environmental
risk factors as well as elucidate genetic factors of NPC.
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