Screening for Nasopharyngeal Carcinoma in High Risk Populations
This study is currently recruiting participants.
Verified July 2009 by Sun Yat-sen University
Sponsor:
Sun Yat-sen University
Collaborators:
Cancer Research Institute of Zhongshan City
Sihui Cancer Institute
Information provided by:
Sun Yat-sen University
ClinicalTrials.gov Identifier:
NCT00941538
First received: July 16, 2009
Last updated: July 21, 2009
Last verified: July 2009
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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 ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Cost-effectiveness of screening [ Time Frame: July, 2019 ] [ Designated as safety issue: Yes ]
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| Ages Eligible for Study: | 30 Years to 59 Years |
| Genders Eligible for Study: | Both |
| 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
Please refer to this study by its ClinicalTrials.gov identifier: 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
No publications provided by Sun Yat-sen University
Additional 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 |
| Study First Received: | July 16, 2009 |
| Last Updated: | July 21, 2009 |
| Health Authority: | China: Ministry of Health |
Keywords provided by Sun Yat-sen University:
|
nasopharyngeal cancer screening biomarker early detection epidemiological survey |
Additional relevant MeSH terms:
|
Nasopharyngeal Neoplasms Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Pharyngeal Neoplasms Otorhinolaryngologic Neoplasms Head and Neck Neoplasms |
Neoplasms by Site Nasopharyngeal Diseases Carcinoma Pharyngeal Diseases Stomatognathic Diseases Otorhinolaryngologic Diseases |
ClinicalTrials.gov processed this record on May 16, 2013