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Screening for Nasopharyngeal Carcinoma in High Risk Populations

This study is currently recruiting participants.
Verified July 2009 by Sun Yat-sen University
Sponsor:
ClinicalTrials.gov Identifier:
NCT00941538
First Posted: July 17, 2009
Last Update Posted: July 23, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborators:
Cancer Research Institute of Zhongshan City
Sihui Cancer Institute
Information provided by:
Sun Yat-sen University
  Purpose
Compared with the early diagnosis rate and the mortality rate between the patients of nasopharyngeal carcinoma (NPC) from the screening group and the control group, new screening protocol is conducted into high-risk population in Guangdong Province, China. Meanwhile, we also perform epidemiological surveys of the screening population to acquire the baseline information. Through analyzing the risk factors, this study can provide a population-based prospective evidences to better understand the reasons of NPC onset in high-risk population.

Condition
Nasopharyngeal Cancer Screening

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Screening for Nasopharyngeal Carcinoma (NPC) on the High Risk Area and Evaluation on the Project of Early Diagnosis and Treatment

Resource links provided by NLM:


Further study details as provided by Sun Yat-sen University:

Primary Outcome Measures:
  • Improve early diagnosis rate and reduce mortality rate of nasopharyngeal carcinoma [ Time Frame: July, 2019 ]

Secondary Outcome Measures:
  • Cost-effectiveness of screening [ Time Frame: July, 2019 ]

Biospecimen Retention:   Samples With DNA
Whole blood, Serum, White cells, pathological tissue

Estimated Enrollment: 30000
Study Start Date: June 2009
Estimated Study Completion Date: July 2019
Estimated Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
Screening, Control

Detailed Description:

Sample selection

  • Select communities of 70,000 to 120,000 populations in Sihui and Zhongshan City as our fields by cluster sampling randomization
  • Divide them into screening group and control group according to the areas of administration

Participants recruitment

  • Subjects voluntarily attend this screening study
  • Informed consents are performed at the recruitment

Questionnaires

- Face-to-face interviews are conducted by well-trained investigators

Physical examinations

- Each participants are performed medical services such as otorhinolaryngologic and lymphatic examinations

Serological tests

  • Each blood samples are tested for IgA antibodies against EBV capsid antigen (VCA/IgA) and IgA antibodies against EBV nuclear antigen 1 (EBNA1/IgA)
  • If the results reach the serological definition of high-risk populations, fiberoptic endoscopy and pathological biopsy were performed by otorhinolaryngologists
  • The rest of the blood samples will be stored at the biobank of Sun Yat-sen University Cancer Center

Follow up

- The cohort will follow up according to the screening protocol

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 59 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Cantonese Residents of Zhongshan City; Cantonese Residents of Sihui City
Criteria

Inclusion Criteria:

  • Cantonese who residing in Sihui or Zhongshan City
  • Have no medical records of nasopharyngeal carcinoma
  • ECOG 0-2
  • Should subscribe informed consents
  • Have good psychical condition and well consciousness

Exclusion Criteria:

  • Have heavy cardiovascular, liver or kidney disease
  • Have medical records of nasopharyngeal carcinoma
  • Those who are not residing in Sihui or Zhongshan City
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00941538


Contacts
Contact: Sumei Cao, M.D., Ph.D 86-20-87343050 caosumei@mail.sysu.edu.cn

Locations
China, Guangdong
Sihui Cancer Institute Recruiting
Sihui, Guangdong, China
Contact: Qihong Huang, M.D.    86-758-3327195    gdshci@163.com   
Principal Investigator: Qihong Huang, M.D.         
Cancer Research Institute of Zhongshan City Recruiting
Zhongshan, Guangdong, China
Contact: Mingfang Ji, Ph.D       jmftbh@yahoo.com.cn   
Principal Investigator: Yuanlong Yu, M.D.         
Sub-Investigator: Mingfang Ji, Ph.D         
Sponsors and Collaborators
Sun Yat-sen University
Cancer Research Institute of Zhongshan City
Sihui Cancer Institute
Investigators
Principal Investigator: Minghuang Hong, M.D Sun Yat-sen University
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Minghuang Hong, M.D., Sun Yat-sen University Cancer Center
ClinicalTrials.gov Identifier: NCT00941538     History of Changes
Other Study ID Numbers: No.2006BAI02A11
First Submitted: July 16, 2009
First Posted: July 17, 2009
Last Update Posted: July 23, 2009
Last Verified: July 2009

Keywords provided by Sun Yat-sen University:
nasopharyngeal cancer
screening
biomarker
early detection
epidemiological survey

Additional relevant MeSH terms:
Nasopharyngeal Neoplasms
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms
Nasopharyngeal Diseases
Pharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases