Screening Nasopharyngeal Carcinoma With EBV Associated Biomarkers in Zhongshan City
Study Details
Study Description
Brief Summary
All participants will be tested for EBV associated biomarkers, including EBNA1-IgA, VCA-IgA, BNLF2b total antibodies (P85-Ab) et al. For all male participants and P85-Ab positive female participants, EBV DNA in plasma will be tested. Screening positive participants will be followed up annually.
All subjects will also be followed by record linkage to Cancer Register and Population Register.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Detailed Description
Sample selection
- Select communities of 20,000 to 40,000 populations in Zhongshan City and Wuzhou city as the investigators' fields.
Participants recruitment
-
Subjects voluntarily attend this screening study Informed consent - Informed consent forms will be collected at the recruitment. Questionnaires.
-
Face-to-face interviews are conducted by well-trained investigators.
Tests and follow up
-
At initial screening, all participants will be tested for EBV associated biomarkers, including EBNA1-IgA, VCA-IgA, P85-Ab et al. And in males, EBV-DNA will be tested. Based on EBNA1-IgA, VCA-IgA, participants will be stratified into high, moderate and low risk. Screening positive include P85-Ab positive, high or moderate risk of NPC or EBV DNA positive. The rest will be screening negative.
-
During the initial screening and following up, people with high risk or P85-Ab positive will refer to the diagnostic workup for NPC. Briefly, fiberoptic endoscopy and pathological biopsy will be performed by otorhinolaryngologists.
-
Screening positive people not diagnosed as nasopharyngeal carcinoma in the first year will be followed up annually.
-
EBV DNA single positive people will refer to the diagnostic workup for NPC in the third year of follow up.
-
The rest of the blood samples will be stored at the biobank of Zhongshan People's Hospital for further research.
-
All subjects will also be followed by record linkage to Cancer Register and Population Register.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Screening cohort 30-69 years old healthy participants in Zhongshan and Wuzhou. |
Biological: Blood and saliva
Collect blood and saliva samples from participants
Diagnostic Test: P85-Ab, EBNA1-IgA, VCA-IgA and EBV DNA
Detect P85-Ab, EBNA1-IgA, VCA-IgA for all participants, and detect EBV DNA for all male participants and P85-Ab positive female participants.
Diagnostic Test: Fiberoptic endoscopy and biopsy
Screening participants will refer to fiberoptic endoscopy and biospy
|
Outcome Measures
Primary Outcome Measures
- Sensitivity and specificity of different EBV associated biomarkers [5 years]
To compare the sensitivity and specificity of different EBV associated biomarkers for NPC
- Positive and negative predictive values of different EBV associated biomarkers [5 years]
To compare the positive and negative predictive values of different EBV associated biomarkers for NPC
Secondary Outcome Measures
- Number needed to screen to identify one nasopharyngeal carcinoma [5 years]
To compare the number of participants needed to screen identify one nasopharyngeal carcinoma for different biomarkers
- Early diagnosis rate of nasopharyngeal carcinoma [5 years]
To compare the early diagnosis rate of different biomarkers for nasopharyngeal carcinoma
Other Outcome Measures
- The health economic benefits of different biomarkers for nasopharyngeal carcinoma [5 years]
To explore the overall survival rate, progression free survival rate and health economic benefits of NPC screening using different biomarkers
- New screening strategy of nasopharyngeal carcinoma screening [5 years]
Comprehensive analysis of the performance of different biomarkers and their combination in the screening of nasopharyngeal carcinoma
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Subject residents in Zhongshan City or Wuzhou City
-
Subject has no medical record of nasopharyngeal carcinoma
-
ECOG 0-2
-
Subject is able to comprehend, sign, and date the written informed consent document to participate in the study.
-
Subject has psychical condition and well consciousness, and also accept and cooperate with the follow-up of this study.
Exclusion Criteria:
-
Subject has heavy cardiovascular, liver or kidney disease.
-
Subject has contraindications to nasopharyngeal fiberoptic endoscopy.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Zhongshan People's Hospital | Zhongshan | Guangdong | China | 528403 |
| 2 | Wuzhou Red Cross Hospital | Wuzhou | Guangxi | China | 543002 |
Sponsors and Collaborators
- Zhongshan People's Hospital, Guangdong, China
- Wuzhou Red Cross Hospital
- Xiamen University
Investigators
- Principal Investigator: Mingfang Ji, MD, Zhongshan People's Hospital, Guangdong, China
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- NPC-PRO-003