Screening Nasopharyngeal Carcinoma With EBV Associated Biomarkers in Zhongshan City

Zhongshan City People's Hospital

Status

Enrolling

Conditions

Nasopharyngeal Carcinoma

Treatments

Biological: Blood and saliva

Diagnostic Test: Fiberoptic endoscopy and biopsy

Diagnostic Test: P85-Ab, EBNA1-IgA, VCA-IgA and EBV DNA

Study type

Observational

Funder types

Other

Identifiers

NCT04085900

NPC-PRO-003

Details and patient eligibility

About

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.

Full 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.

Enrollment

40,000 estimated patients

Sex

All

Ages

30 to 69 years old

Volunteers

Accepts Healthy Volunteers

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