Clinical Trials Logo

Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01257100
Other study ID # 999911040
Secondary ID 11-C-N040
Status Terminated
Phase
First received
Last updated
Start date December 8, 2010
Est. completion date June 2, 2020

Study information

Verified date June 2020
Source National Institutes of Health Clinical Center (CC)
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Locations

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

Sponsors (7)

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

Country where clinical trial is conducted

Taiwan, 

References & 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. — 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

Outcome

Type Measure Description Time frame Safety issue
Primary Nasopharyngeal carcinoma NPC diagnosis
See also
  Status Clinical Trial Phase
Completed NCT01256853 - Modified Vaccinia Ankara (MVA) Vaccine Study Phase 1
Not yet recruiting NCT00577057 - Benefit of Changing Chemoradiotherapy Sequence and Modifying Radiotherapy Schedule for Advanced Nasopharyngeal Cancer N/A
Recruiting NCT02945878 - Predictive Factors of Acute Oral Mucositis Induced by Chemo-radiotherapy for Local Advanced Nasopharyngeal Carcinoma N/A
Terminated NCT02874651 - ADjuVant Apatinib in Nasopharyngeal Carcinoma Patients With Residual Epstein-Barr Virus (EBV) DNA Following Radiotherapy Phase 2
Not yet recruiting NCT05807880 - Anlotinib, Penpulimab and Capecitabine in Recurrent/Metastatic Nasopharyngeal Carcinoma Phase 2
Completed NCT00342147 - Family Study of Head and Neck Cancers in Taiwan
Recruiting NCT02980315 - A New EBV Related Technologies of T Cells in Treating Malignant Tumors and Clinical Application Phase 1/Phase 2
Active, not recruiting NCT01735409 - Dose-finding Study of Abraxane in Combination With Cisplatin to Treat Advanced Nasopharyngeal Carcinoma Phase 1/Phase 2
Completed NCT00630149 - Study of Alimta in Patients With Recurrent or Metastatic Nasopharyngeal Carcinoma (NPC) Who Have Had Prior Platinum Based Chemotherapy Phase 2
Completed NCT00565448 - Docetaxel in Combination With Cisplatin-5-fluorouracil for the Induction Treatment of Nasopharyngeal Carcinoma in Children and Adolescents Phase 2
Active, not recruiting NCT03854838 - IMRT Combined With Toripalimab in Unresectable Locally Recurrent Nasopharyngeal Carcinoma. Phase 2
Completed NCT01797900 - The Role of Induction Chemotherapy for High-risk Locally Advanced Nasopharyngeal Carcinoma in the Era of IMRT Phase 2
Completed NCT00436800 - Gemcitabine and Oxaliplatin (GEMOX) in First Line Metastatic or Recurrent Nasopharyngeal Carcinoma Phase 2
Active, not recruiting NCT00563927 - Benefit of Adding Chemotherapy for Advance Nasopharyngeal Carcinoma (T1-4N2-3M0) N/A
Not yet recruiting NCT04870905 - Tisleilizumab (PD-1 Antibody) and Chemoradiotherapy in Locoregionally-advanced Nasopharyngeal Carcinoma Phase 2
Active, not recruiting NCT02902432 - A Trial of Endostar in Patients With Carcinoma of the Head and Neck Phase 2
Active, not recruiting NCT02456506 - Hyperfractionated Intensity-modulated Radiotherapy (IMRT) Versus Conventional Fraction IMRT for Patients With Loco-regionally Recurrent Nasopharyngeal Carcinoma. N/A
Completed NCT02444949 - A Trial of Endostar in Combination With Chemotherapy of DF and Sequential Intensity Modulated Radiation Therapy for Patients With Advanced Nasopharyngeal Carcinoma Phase 2
Completed NCT00188877 - Intensity Modulated Radiation Therapy for Head and Neck Cancer Phase 2
Terminated NCT00393224 - Defining the Clinical Utility of EBV Antibody Screening to Identify Individuals Susceptible to Nasopharyngeal Carcinoma (NPC) Within High-Risk, Multiplex NPC Families