Environmental and Genetic Determinants of NPC

NCT01257100 | Terminated

• 2 other identifiers: 99991104011-C-N040
• Study Type: observational
• Target: 3,500
• Locations: 1 country
• Sites: 6

Brief Summary

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.

Conditions

Nasopharyngeal Neoplasms; Herpesvirus 4, Human

Keywords

Nasopharyngeal Carcinoma; Epstein-Barr Virus; NPC

Outcome Measures

Primary Outcomes (1)

• Nasopharyngeal carcinoma

  NPC diagnosis

Study Arms (2)

Cases with NPC

Cases with NPC

Hospital based controls

Hospital based controls

Eligibility Criteria

• Age: 21 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This is a hospital based case control population

You may qualify if:

• 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

You may not qualify if:

• \- Clinic attendance due to conditions associated with EBV or smoking

Sponsors & Collaborators

• National Cancer Institute (NCI): lead
• Academia Sinica, Taiwan: collaborator
• National Taiwan University Hospital: collaborator
• Koo Foundation Sun Yat-Sen Cancer Center: collaborator
• Mackay Memorial Hospital: collaborator
• Far Easter Memorial Hospital: collaborator
• Cathay General Hospital: collaborator

Study Sites (6)

Academia Sinica 128 Academia Road

Taipei, Taiwan

Location

Cathay General Hospital 280 Renai Rd, Section 4

Taipei, Taiwan

Location

Far Easter Memorial Hospital 21, NanYa S. Rd, Section 2, Ban-Chiao

Taipei, Taiwan

Location

Koo Foundation Sun Yat-Sen Cancer Center

Taipei, Taiwan

Location

MacKay Memorial Hospital No 92, Section 2, Zhongshan N. Rd, Zhongshan Dist

Taipei, Taiwan

Location

National Taiwan University Hospital

Taipei, Taiwan

Location

Related Publications (3)

• Armstrong RW, Imrey PB, Lye MS, Armstrong MJ, Yu MC, Sani S. Nasopharyngeal carcinoma in Malaysian Chinese: salted fish and other dietary exposures. Int J Cancer. 1998 Jul 17;77(2):228-35. doi: 10.1002/(sici)1097-0215(19980717)77:23.0.co;2-7.

  PMID: 9650558 BACKGROUND

• Bei JX, Li Y, Jia WH, Feng BJ, Zhou G, Chen LZ, Feng QS, Low HQ, Zhang H, He F, Tai ES, Kang T, Liu ET, Liu J, Zeng YX. A genome-wide association study of nasopharyngeal carcinoma identifies three new susceptibility loci. Nat Genet. 2010 Jul;42(7):599-603. doi: 10.1038/ng.601. Epub 2010 May 30.

  PMID: 20512145 BACKGROUND

• Blair A, Saracci R, Stewart PA, Hayes RB, Shy C. Epidemiologic evidence on the relationship between formaldehyde exposure and cancer. Scand J Work Environ Health. 1990 Dec;16(6):381-93. doi: 10.5271/sjweh.1767.

  PMID: 2284588 BACKGROUND

MeSH Terms

Conditions

Nasopharyngeal Neoplasms; Epstein-Barr Virus Infections; Nasopharyngeal Carcinoma

Condition Hierarchy (Ancestors)

Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Tumor Virus Infections; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Study Officials

• Allan Hildesheim, Ph.D.

  National Cancer Institute (NCI)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: OTHER
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2010
• First Posted: December 9, 2010
• Study Start: December 8, 2010
• Primary Completion: June 2, 2020
• Study Completion: June 2, 2020
• Last Updated: June 4, 2020

Record last verified: 2020-06

Locations

TW (6)