Screening Nasopharyngeal Carcinoma With EBV Associated Biomarkers in Zhongshan City

Recruiting

• Conditions: Nasopharyngeal Carcinoma
• Interventions: Biological: Blood and saliva; Diagnostic Test: P85-Ab, EBNA1-IgA, VCA-IgA and EBV DNA; Diagnostic Test: Fiberoptic endoscopy and biopsy

• Registration Number: NCT04085900
• Lead Sponsor: Zhongshan People's Hospital, Guangdong, China

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.

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 Timeline

• Study First Submitted: 2019-09-09
• Study First Submitted QC: 2019-09-09
• Study First Posted: 2019-09-11
• Study Start: 2020-04-01
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-12
• Last Update Posted: 2023-07-13
• Primary Completion: 2024-12-31
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40000

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Screening cohort	Blood and saliva	30-69 years old healthy participants in Zhongshan and Wuzhou.
Screening cohort	Fiberoptic endoscopy and biopsy	30-69 years old healthy participants in Zhongshan and Wuzhou.
Screening cohort	P85-Ab, EBNA1-IgA, VCA-IgA and EBV DNA	30-69 years old healthy participants in Zhongshan and Wuzhou.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Early diagnosis rate of nasopharyngeal carcinoma	5 years	To compare the early diagnosis rate of different biomarkers for nasopharyngeal carcinoma
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

Trial Locations

Locations (2)

Zhongshan People's Hospital; 🇨🇳 Zhongshan, Guangdong, China

Wuzhou Red Cross Hospital; 🇨🇳 Wuzhou, Guangxi, China