Screening Nasopharyngeal Carcinoma With EBV Associated Biomarkers in Zhongshan City

NCT04085900 · tracked via the Priya Life Science China tracker

Sponsor

Zhongshan People's Hospital, Guangdong, China

Phase

Observational

Started

2020-04-01

Last updated

2023-07-13

Condition(s) studied

Nasopharyngeal Carcinoma

Investigational drug(s) / intervention(s)

Blood and salivaP85-Ab, EBNA1-IgA, VCA-IgA and EBV DNAFiberoptic endoscopy and biopsy

Blood and saliva: Collect blood and saliva samples from participants

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

Study 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.

Eligibility

Sex

ALL

Min age

30 Years

Max age

69 Years

Healthy volunteers

Accepted

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.

Primary outcome measure(s)

Sensitivity and specificity of different EBV associated biomarkers — 5 years
To compare the sensitivity and specificity of different EBV associated biomarkers for NPC
Positive and negative predictive values of different EBV associated biomarkers — 5 years
To compare the positive and negative predictive values of different EBV associated biomarkers for NPC

Trial sites (2)

Facility	City	Region	Status
Zhongshan People's Hospital	Zhongshan	Guangdong	Recruiting
Wuzhou Red Cross Hospital	Wuzhou	Guangxi	Recruiting

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Other trials for the same condition

Maintenance Therapy With Toripalimab Combined With Capecitabine/Placebo for Recurrent and Metastatic Nasopharyngeal Carcinoma Active, not recruiting

Pretreatment With HCQ Before Radiotherapy and Chemotherapy in Advanced NPC Patients Recruiting

Clinical Study on the EBV CAR-T /TCR-T Cells in the Treatment of Nasopharyngeal Carcinoma Recruiting

Penpulimab Combined With GP ± Anlotinib as Neoadjuvant Therapy in Locoregionally Advanced Nasopharyngeal Carcinoma Active, not recruiting

The Role of Induction Gemcitabine and Cisplatin in Locoregionally Advanced Nasopharyngeal Carcinoma in the Era of IMRT Active, not recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04085900 on ClinicalTrials.gov ↗ ← All trials in China