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NCT Number: NCT04085900

Screening Nasopharyngeal Carcinoma With EBV Associated Biomarkers in Zhongshan City

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.

Recruiting

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Key information

Age range

30 year–69 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Zhongshan People's Hospital, Zhongshan, Guangdong, China

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Blood and saliva

Biological

Collect blood and saliva samples from participants

P85-Ab, EBNA1-IgA, VCA-IgA and EBV DNA

Diagnostic Test

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

Diagnostic Test

Screening participants will refer to fiberoptic endoscopy and biospy

Primary outcomes

  1. Sensitivity and specificity of different EBV associated biomarkers

    Time frame: 5 years

    To compare the sensitivity and specificity of different EBV associated biomarkers for NPC

  2. Positive and negative predictive values of different EBV associated biomarkers

    Time frame: 5 years

    To compare the positive and negative predictive values of different EBV associated biomarkers for NPC

Secondary outcomes

  1. Number needed to screen to identify one nasopharyngeal carcinoma

    Time frame: 5 years

    To compare the number of participants needed to screen identify one nasopharyngeal carcinoma for different biomarkers

  2. Early diagnosis rate of nasopharyngeal carcinoma

    Time frame: 5 years

    To compare the early diagnosis rate of different biomarkers for nasopharyngeal carcinoma

Other outcomes

  1. The health economic benefits of different biomarkers for nasopharyngeal carcinoma

    Time frame: 5 years

    To explore the overall survival rate, progression free survival rate and health economic benefits of NPC screening using different biomarkers

  2. New screening strategy of nasopharyngeal carcinoma screening

    Time frame: 5 years

    Comprehensive analysis of the performance of different biomarkers and their combination in the screening of nasopharyngeal carcinoma

Study contacts

Contact information is provided by the study sponsor or research team.

Mingfang Ji, MD

CONTACT

[email protected]

86-760-89880417

Sponsors and collaborators

Lead sponsor

Zhongshan People's Hospital, Guangdong, China

Other

Collaborators

  • Wuzhou Red Cross Hospital
  • Xiamen University

Registry information

Official study title

Searching for Early Detection Biomarkers of Nasopharyngeal Carcinoma in Zhongshan City

Important dates

Study start
2020
Primary completion
2024
Study completion
2027
First posted
Sep 11, 2019
Registry last updated
Jul 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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