Screening Nasopharyngeal Carcinoma With EBV Associated Biomarkers in Zhongshan City
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Blood and saliva, P85-Ab, EBNA1-IgA, VCA-IgA and EBV DNA, Fiberoptic endoscopy and biopsy.
- Who it may be relevant to
- Registry conditions: Nasopharyngeal Carcinoma. Basic parameters: 30 years — 69 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Searching for Early Detection Biomarkers of Nasopharyngeal Carcinoma in Zhongshan City
Overview
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.
Interventions
- 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
Primary outcome measures
- Sensitivity and specificity of different EBV associated biomarkers [Time frame: 5 years]
- Positive and negative predictive values of different EBV associated biomarkers [Time frame: 5 years]
Secondary outcome measures (2)
- Number needed to screen to identify one nasopharyngeal carcinoma [Time frame: 5 years]
- Early diagnosis rate of nasopharyngeal carcinoma [Time frame: 5 years]
Eligibility 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
China · 2 centers
- Zhongshan People's Hospital — Zhongshan
- Wuzhou Red Cross Hospital — Wuzhou
Publications
- Li T, Li F, Guo X, Hong C, Yu X, Wu B, Lian S, Song L, Tang J, Wen S, Gao K, Hao M, Cheng W, Su Y, Zhang S, Huang S, Fang M, Wang Y, Ng MH, Chen H, Luo W, Ge S, Zhang J, Xia N, Ji M. Anti-Epstein-Barr Virus BNLF2b for Mass Screening for Nasopharyngeal Cancer. N Engl J Med. 2023 Aug 31;389(9):808-819. doi: 10.1056/NEJMoa2301496. PMID 37646678
Identifiers
NCT: NCT04085900 · NPC-PRO-003