Cluster Randomized Controlled Screening Trial for NPC

NCT00941538 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 87600

Last updated 2023-02-28

No results posted yet for this study

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.

Conditions

  • Nasopharyngeal Cancer
  • Screening
  • Morality

Interventions

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.

Sponsors & Collaborators

  • Cancer Research Institute of Zhongshan City

    collaborator OTHER_GOV
  • Sihui Cancer Institute

    collaborator OTHER
  • Sun Yat-sen University

    lead OTHER

Principal Investigators

  • Minghuang Hong, M.D · Sun Yat-sen University

Study Design

Allocation
RANDOMIZED
Purpose
SCREENING
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
69 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-01-31
Primary Completion
2019-12-31
Completion
2023-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00941538 on ClinicalTrials.gov