Clinical trial NCT00941538: Cluster Randomized Controlled Screening Trial for NPC
Official title: A Cluster Randomized Controlled Screening Trial for Nasopharyngeal Carcinoma in Southern China (CRCSTNPC Study)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Nasopharyngeal Cancer
Screening
Morality
Keywords: nasopharyngeal cancer
screening
early detection
mortality
randomized control trial
Epstain-Barr Virus
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
Collaborators: name: Cancer Research Institute of Zhongshan City
name: Sihui Cancer Institute
First posted: 2009-07-17
Enrollment: 87600
Sex: ALL
Minimum age (years): 30
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

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

Eligibility criteria: 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.

Primary outcomes:
measure: Mortality rate of NPC at 12 years by intervention group
timeFrame: December, 2019
Secondary outcomes:
measure: All-cause mortality at 12 years by intervention group
timeFrame: December, 2019
measure: NPC incidence at 12 years by intervention group
timeFrame: December, 2019
measure: Stage distribution at diagnosis for NPC patients by intervention group
timeFrame: December, 2019
measure: NPC overall survival by cases from the two intervention groups
timeFrame: December, 2019
measure: Cost-effectiveness
timeFrame: December, 2019
Other outcomes:
Locations:
city: Sihui
country: China
facility: Sihui Cancer Institute
state: Guangdong
city: Zhongshan
country: China
facility: Cancer Research Institute of Zhongshan City
state: Guangdong
Study officials:
affiliation: Sun Yat-sen University
name: Minghuang Hong, M.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ji MF, Sheng W, Cheng WM, Ng MH, Wu BH, Yu X, Wei KR, Li FG, Lian SF, Wang PP, Quan W, Deng L, Li XH, Liu XD, Xie YL, Huang SJ, Ge SX, Huang SL, Liang XJ, He SM, Huang HW, Xia SL, Ng PS, Chen HL, Xie SH, Liu Q, Hong MH, Ma J, Yuan Y, Xia NS, Zhang J, Cao SM. Incidence and mortality of nasopharyngeal carcinoma: interim analysis of a cluster randomized controlled screening trial (PRO-NPC-001) in southern China. Ann Oncol. 2019 Oct 1;30(10):1630-1637. doi: 10.1093/annonc/mdz231.
citation: Liu Z, Ji MF, Huang QH, Fang F, Liu Q, Jia WH, Guo X, Xie SH, Chen F, Liu Y, Mo HY, Liu WL, Yu YL, Cheng WM, Yang YY, Wu BH, Wei KR, Ling W, Lin X, Lin EH, Ye W, Hong MH, Zeng YX, Cao SM. Two Epstein-Barr virus-related serologic antibody tests in nasopharyngeal carcinoma screening: results from the initial phase of a cluster randomized controlled trial in Southern China. Am J Epidemiol. 2013 Feb 1;177(3):242-50. doi: 10.1093/aje/kws404. Epub 2012 Dec 19.