Cluster Randomized Controlled Screening Trial for NPC

Not Applicable

Active, not recruiting

• Conditions: Morality; Nasopharyngeal Cancer; Screening

• Registration Number: NCT00941538
• Lead Sponsor: Sun Yat-sen University

Brief 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

Study Timeline

• Study Start: 2008-01
• Study First Submitted: 2009-07-16
• Study First Submitted QC: 2009-07-16
• Study First Posted: 2009-07-17
• Primary Completion: 2019-12
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-26
• Last Update Posted: 2023-02-28
• Study Completion: 2023-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 87600

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Mortality rate of NPC at 12 years by intervention group	December, 2019	NPC mortality rate will be compared between screening group and control group at 12-year follow-up.

Secondary Outcome Measures

Name	Time	Method
Stage distribution at diagnosis for NPC patients by intervention group	December, 2019	Stage distribution will be compared between screening group and control group at 12-year follow-up.
Cost-effectiveness	December, 2019	Cost-effectiveness of this screening program will be calculated at 12-year follow-up.
All-cause mortality at 12 years by intervention group	December, 2019	All-cause mortality rate will be compared between screening group and control group at 12-year follow-up.
NPC incidence at 12 years by intervention group	December, 2019	NPC incidence rate will be compared between screening group and control group at 12-year follow-up.
NPC overall survival by cases from the two intervention groups	December, 2019	Survival rate will be compared between screening group and control group at 12-year follow-up.

Trial Locations

Locations (2)

Sihui Cancer Institute; 🇨🇳 Sihui, Guangdong, China

Cancer Research Institute of Zhongshan City; 🇨🇳 Zhongshan, Guangdong, China