Environmental and Genetic Determinants of NPC

June 3, 2020 updated by: National Cancer Institute (NCI)

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.

Study Overview

Status

Terminated

Conditions

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

3500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taipei, Taiwan
        • National Taiwan University Hospital
      • Taipei, Taiwan
        • Academia Sinica 128 Academia Road
      • Taipei, Taiwan
        • Cathay General Hospital 280 Renai Rd, Section 4
      • Taipei, Taiwan
        • Far Easter Memorial Hospital 21, NanYa S. Rd, Section 2, Ban-Chiao
      • Taipei City, Taiwan
        • Koo Foundation Sun Yat-Sen Cancer Center
      • Taipei City, Taiwan
        • MacKay Memorial Hospital No 92, Section 2, Zhongshan N. Rd, Zhongshan Dist

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

This is a hospital based case control population

Description

  • INCLUSION CRITERIA:

Eligibility criteria for cases:

  • Incident diagnosis of NPC between 2010-2015
  • Age greater than or equal to 21 years at NPC diagnosis
  • Histologically confirmed
  • Resident of northern Taiwan greater than or equal to 6 months

Eligibility criteria for controls:

  • Resident of northern Taiwan greater than or equal to 6 months
  • Matched to case based on age at diagnosis, gender, and ethnicity

EXCLUSION CRITERIA:

Exclusion criteria for controls:

- Clinic attendance due to conditions associated with EBV or smoking

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Cases with NPC
Hospital based controls

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Nasopharyngeal carcinoma
NPC diagnosis

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cancer Institute (NCI)

Collaborators

National Taiwan University Hospital
Mackay Memorial Hospital
Cathay General Hospital
Academia Sinica, Taiwan
Koo Foundation Sun Yat-Sen Cancer Center
Far Easter Memorial Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 8, 2010

Primary Completion (Actual)

June 2, 2020

Study Completion (Actual)

June 2, 2020

Study Registration Dates

First Submitted

December 8, 2010

First Submitted That Met QC Criteria

December 8, 2010

First Posted (Estimate)

December 9, 2010

Study Record Updates

Last Update Posted (Actual)

June 4, 2020

Last Update Submitted That Met QC Criteria

June 3, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 999911040
  • 11-C-N040

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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