Screening Nasopharyngeal Carcinoma With EBV Associated Biomarkers in Zhongshan City

Nasopharyngeal Carcinoma Clinical Trial

Official title:

Searching for Early Detection Biomarkers of Nasopharyngeal Carcinoma in Zhongshan City

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04085900
• Other study ID #: NPC-PRO-003
• Status: Recruiting
• Start date: April 1, 2020
• Est. completion date: December 31, 2027

Study information

• Verified date: July 2023
• Source: Zhongshan People's Hospital, Guangdong, China
• Contact: Mingfang Ji, MD
• Phone: 86-760-89880417
• Email: jmftbh[@]sina.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40000
• Est. completion date: December 31, 2027
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 69 Years

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Nasopharyngeal Carcinoma

Intervention

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.
• Fiberoptic endoscopy and biopsy
Screening participants will refer to fiberoptic endoscopy and biospy

Locations

Country	Name	City	State
China	Wuzhou Red Cross Hospital	Wuzhou	Guangxi
China	Zhongshan People's Hospital	Zhongshan	Guangdong

Sponsors (3)

Lead Sponsor	Collaborator
Zhongshan People's Hospital, Guangdong, China	Wuzhou Red Cross Hospital, Xiamen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The health economic benefits of different biomarkers for nasopharyngeal carcinoma	To explore the overall survival rate, progression free survival rate and health economic benefits of NPC screening using different biomarkers	5 years
Other	New screening strategy of nasopharyngeal carcinoma screening	Comprehensive analysis of the performance of different biomarkers and their combination in the screening of nasopharyngeal carcinoma	5 years
Primary	Sensitivity and specificity of different EBV associated biomarkers	To compare the sensitivity and specificity of different EBV associated biomarkers for NPC	5 years
Primary	Positive and negative predictive values of different EBV associated biomarkers	To compare the positive and negative predictive values of different EBV associated biomarkers for NPC	5 years
Secondary	Number needed to screen to identify one nasopharyngeal carcinoma	To compare the number of participants needed to screen identify one nasopharyngeal carcinoma for different biomarkers	5 years
Secondary	Early diagnosis rate of nasopharyngeal carcinoma	To compare the early diagnosis rate of different biomarkers for nasopharyngeal carcinoma	5 years