Screening Nasopharyngeal Carcinoma With EBV Associated Biomarkers in Zhongshan City

Официальное название

Searching for Early Detection Biomarkers of Nasopharyngeal Carcinoma in Zhongshan City

Обзор

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.

Подробное описание

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.

Вмешательства

• Биопрепарат Blood and saliva
  Collect blood and saliva samples from participants
• Диагностический тест 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.
• Диагностический тест Fiberoptic endoscopy and biopsy
  Screening participants will refer to fiberoptic endoscopy and biospy

Первичные конечные точки

• Sensitivity and specificity of different EBV associated biomarkers [Срок оценки: 5 years]
• Positive and negative predictive values of different EBV associated biomarkers [Срок оценки: 5 years]

Вторичные конечные точки (2)

• Number needed to screen to identify one nasopharyngeal carcinoma [Срок оценки: 5 years]
• Early diagnosis rate of nasopharyngeal carcinoma [Срок оценки: 5 years]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• Subject has heavy cardiovascular, liver or kidney disease.
• Subject has contraindications to nasopharyngeal fiberoptic endoscopy.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Китай · 2 центра

• Zhongshan People's Hospital — Zhongshan
• Wuzhou Red Cross Hospital — Wuzhou

Публикации

• 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

Идентификаторы

NCT: NCT04085900 · NPC-PRO-003

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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