- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02501993
Nasopharyngeal Carcinoma Screening in Zhongshan City
Serology Screening Test for the Detection of Nasopharyngeal Carcinoma in Zhongshan City
The primary objective is to determine the early diagnosis rate and mortality rate of the Nasopharyngeal Carcinoma (NPC) in the study population.
The secondary objective is to determine the incidence of NPC in the study population.
Study Overview
Status
Conditions
Detailed Description
The research is to evaluate the effect of NPC screening, also as an extended study of Screening for Nasopharyngeal Carcinoma in High Risk Populations (NCT00941538).
The program was conducted in Xiaolan and Minzhong towns of Zhongshan city in 2012.
All participants will be tested for anti-EBV antibody by using serum samples. Participants are stratified into those having high, moderate and low antibody levels, those having moderate antibody levels are invited to retest annually in the following 3 years and those found to have high antibody levels on these occasions are referred to centers for diagnostic workup for NPC.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Mingfang Ji, MD
- Email: jmftbh@sina.com
Study Locations
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Guangdong
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Zhongshan, Guangdong, China, 528403
- Zhongshan People's Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Subject residents in Zhongshan city
- Subject is 30 to 59 years of age inclusive
- Subject has no medical record of nasopharyngeal carcinoma
- ECOG 0-2
- Subject has psychical condition and well consciousness
- Subject is able to comprehend, sign, and date the written informed consent document to participate in the study.
Exclusion Criteria:
- Subject has heavy cardiovascular, liver or kidney disease
- Subject has medical record of nasopharyngeal carcinoma
- Subject who is not residing in Zhongshan City
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
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Screening cohort
All participants will be tested for anti-EBV antibody by using serum samples.
Participants are stratified into those having high, moderate and low antibody levels, those having moderate antibody levels are invited to retest annually in the following 3 years and those found to have high antibody levels on these occasions are referred to centers for diagnostic workup for NPC.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The early detection rate (stage I and II) of Nasopharyngeal Carcinoma
Time Frame: 10 years
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10 years
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The mortality rate of Nasopharyngeal Carcinoma
Time Frame: 10 years
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10 years
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The incidence of Nasopharyngeal Carcinoma
Time Frame: 10 years
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10 years
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Collaborators and Investigators
Investigators
- Principal Investigator: Mingfang Ji, MD, Zhongshan People's Hospital, Guangdong, China
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Neoplasms, Glandular and Epithelial
- Pharyngeal Neoplasms
- Otorhinolaryngologic Neoplasms
- Head and Neck Neoplasms
- Nasopharyngeal Diseases
- Pharyngeal Diseases
- Stomatognathic Diseases
- Otorhinolaryngologic Diseases
- Nasopharyngeal Neoplasms
- Carcinoma
- Nasopharyngeal Carcinoma
Other Study ID Numbers
- NPC-PRO-002
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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