Nasopharyngeal Neoplasms Clinical Trial
Official title:
Environmental and Genetic Determinants of NPC
Verified date | June 2020 |
Source | National Institutes of Health Clinical Center (CC) |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Terminated |
Enrollment | 3500 |
Est. completion date | June 2, 2020 |
Est. primary completion date | June 2, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 21 Years to 100 Years |
Eligibility |
- 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 |
Country | Name | City | State |
---|---|---|---|
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 | |
Taiwan | National Taiwan University Hospital | Taipei | |
Taiwan | Koo Foundation Sun Yat-Sen Cancer Center | Taipei City | |
Taiwan | MacKay Memorial Hospital No 92, Section 2, Zhongshan N. Rd, Zhongshan Dist | Taipei City |
Lead Sponsor | Collaborator |
---|---|
National Cancer Institute (NCI) | Academia Sinica, Taiwan, Cathay General Hospital, Far Easter Memorial Hospital, Koo Foundation Sun Yat-Sen Cancer Center, Mackay Memorial Hospital, National Taiwan University Hospital |
Taiwan,
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. — View Citation
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. — View Citation
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. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Nasopharyngeal carcinoma | NPC diagnosis |
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