NCT00941538

Cluster Randomized Controlled Screening Trial for NPC

A Cluster Randomized Controlled Screening Trial for Nasopharyngeal Carcinoma in Southern China (CRCSTNPC Study)

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 87,600 (estimated)
• Sponsor: Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 30 Years – 69 Years
• Healthy volunteers: Accepted

Summary

This study is aimed to estimate the effectiveness of an Epstein-Barr virus (EBV) serology-based screening program to reduce nasopharyngeal carcinoma (NPC) mortality in a cluster randomized controlled trial in an NPC high-risk population. Sixteen towns in Sihui and Zhongshan Cities, China will be selected, with eight allocated to the screening group and eight to the control group. Cantonese residents aged 30-69 years with no history of NPC will be included. Residents in the screening towns will be invited to undergo serum EBV VCA/EBNA1 IgA antibody tests.

Detailed description

Nasopharyngeal carcinoma (NPC) has a high prevalence in southern China. Sihui and Zhongshan cities are located along the Pearl River in Guangdong Province, China, and are well known for a high incidence of NPC worldwide. During the last 20 years, Screening for NPC has been demonstrated to increase the early detection rate of NPC in endemic regions. It is well shown that the effect of Epstein-Barr virus (EBV) serological antibodies is elevated several years before NPC diagnosis; therefore, EBV antibodies have been considered screening markers for NPC. However, none of the studies have reported the impact of screening on NPC-specific mortality. This study aims to launch a cluster-randomized screening trial with combined VCA/IgA and EBNA1/IgA measurement by ELISA as the primary screening method in these 2 cities to examine the impact of EBV serological screening on NPC-specific mortality. Residents aged 30-69 years in eight screening towns in the intervention group will be invited to EBV antibody tests-IgA antibodies to EBV VCA/IgA and EBV nuclear antigen-1 (EBNA1/IgA) by ELISA. The primary objective of this trial is to assess an estimate of the EBV serological antibody-based screening for NPC on NPC-specific in the populations with a high incidence of NPC

Conditions

• Nasopharyngeal Cancer
• Screening
• Morality

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Experimental: Screening with EBV VCA/EBNA1-IgA testing	Participants in the screening towns will be offered screening tests. Those with high-risk scores will be referred to a diagnostic workup examination using fiberoptic endoscopy examination and nasopharyngeal biopsies if suspicious lesions is observed.

Timeline

• Start date: 2008-01-01
• Primary completion: 2019-12-01
• Completion: 2023-12-01
• First posted: 2009-07-17
• Last updated: 2023-02-28

Locations

2 sites across 1 country: China