Cluster Randomized Controlled Screening Trial for NPC

Morality Clinical Trial

— CRCSTNPC  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00941538
• Other study ID #: CRCSTNPC
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 2008
• Est. completion date: December 2023

Study information

• Verified date: February 2023
• Source: Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 87600
• Est. completion date: December 2023
• Est. primary completion date: December 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 69 Years

Eligibility

Clusters

1. Inclusion criteria 1) the town located in Sihui or Zhongshan city; 2) the town established a tertiary cancer prevention network; 3) the medical staff in the town hospitals agreed to take part in.

2. Exclusion criteria 1) having conducted NPC screening program.

Individuals

1. Inclusion criteria 1) being aged 30-69 years; 2) being Cantonese; 3) having signed the informed consent; 4) having an Eastern Cooperative Oncology Group score of 0-2; and 5) having a good physical or psychological condition and consciousness.

2. Exclusion criteria 1) having prevalent NPC.

Related Conditions & MeSH terms

• Morality
• Nasopharyngeal Cancer
• Nasopharyngeal Carcinoma
• Nasopharyngeal Neoplasms
• Screening

Intervention

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.

Locations

Country	Name	City	State
China	Sihui Cancer Institute	Sihui	Guangdong
China	Cancer Research Institute of Zhongshan City	Zhongshan	Guangdong

Sponsors (3)

Lead Sponsor	Collaborator
Sun Yat-sen University	Cancer Research Institute of Zhongshan City, Sihui Cancer Institute

Country where clinical trial is conducted

China, 

Outcome

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