Morality, Nasopharyngeal Cancer, Screening
Conditions
Keywords
nasopharyngeal cancer, screening, early detection, mortality, randomized control trial, Epstain-Barr Virus
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
Interventions
DIAGNOSTIC_TESTExperimental: 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.
Sponsors
Cancer Research Institute of Zhongshan City
Sihui Cancer Institute
Sun Yat-sen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
30 Years to 69 Years
Healthy volunteers
Yes
Inclusion 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| Cost-effectiveness | December, 2019 | Cost-effectiveness of this screening program will be calculated at 12-year follow-up. |
Countries
China
Outcome results
None listed