Cluster Randomized Controlled Screening Trial for NPC

NCT00941538 | Unknown DMC

• 1 other identifier: CRCSTNPC
• Study Type: interventional
• Target: 87,600
• Locations: 1 country
• Sites: 2

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.

Conditions

Nasopharyngeal Cancer; Screening; Morality

Keywords

nasopharyngeal cancer; screening; early detection; mortality; randomized control trial; Epstain-Barr Virus

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• All-cause mortality at 12 years by intervention group

  December, 2019

• NPC incidence at 12 years by intervention group

  December, 2019

• Stage distribution at diagnosis for NPC patients by intervention group

  December, 2019

• NPC overall survival by cases from the two intervention groups

  December, 2019

• Cost-effectiveness

  December, 2019

Study Arms (2)

intervention

EXPERIMENTAL

Residents aged 30-69 years in eight screening towns in the intervention group are invited to screening marker tests - IgA antibodies to EBV VCA/IgA and EBV nuclear antigen-1 (EBNA1/IgA) by ELISA. The trial will use two minimally acceptable false-positive rates (i.e., 10% and 3%) as the cutoffs to define "medium-risk" (seropositive, 0.65 ≤ score \< 0.98) and "high-risk" participants (seropositive, score ≥ 0.98). After a blood test, participants whose EBV-based risk exceeds the predefined "high-risk" threshold (score ≥ 0.98) will be referred to endoscopy for clinical evaluation. Participants who are defined as "medium-risk" or "high-risk" (score ≥ 0.65) will be followed annually through blood testing and linkage to registers. The remaining participants (seronegative, score \< 0.65) will be asked to return for a follow-up visit after five years.

Diagnostic Test: Experimental: Screening with EBV VCA/EBNA1-IgA testing

Control

NO INTERVENTION

The individuals aged 30-69 in the other eight towns will be included as controls, which is a comparable population that will not be screened for NPC.

Interventions

Experimental: Screening with EBV VCA/EBNA1-IgA testing DIAGNOSTIC_TEST

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.

Also known as: Diagnostic work-up using fiberoptic endoscopy examination and/or nasopharyngeal biopsies

intervention

Eligibility Criteria

• Age: 30 Years - 69 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• Individuals

Sponsors & Collaborators

• Sun Yat-sen University: lead
• Cancer Research Institute of Zhongshan City: collaborator
• Sihui Cancer Institute: collaborator

Study Sites (2)

Sihui Cancer Institute

Sihui, Guangdong, China

Location

Cancer Research Institute of Zhongshan City

Zhongshan, Guangdong, China

Location

Related Publications (3)

• Chen WJ, Yu X, Lu YQ, Pfeiffer RM, Ling W, Xie SH, Wu ZC, Li XQ, Fan YY, Wu BH, Wei KR, Rao HL, Huang QH, Guo X, Sun Y, Ma J, Liu Q, Hildesheim A, Hong MH, Zeng YX, Ji MF, Liu Z, Cao SM. Impact of an Epstein-Barr Virus Serology-Based Screening Program on Nasopharyngeal Carcinoma Mortality: A Cluster-Randomized Controlled Trial. J Clin Oncol. 2025 Jan;43(1):22-31. doi: 10.1200/JCO.23.01296. Epub 2024 Oct 1.

  PMID: 39353160 DERIVED

• 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.

  PMID: 31373615 DERIVED

• 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.

  PMID: 23255783 DERIVED

MeSH Terms

Conditions

Nasopharyngeal Neoplasms

Condition Hierarchy (Ancestors)

Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases

Study Officials

• Minghuang Hong, M.D

  Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 16, 2009
• First Posted: July 17, 2009
• Study Start: January 1, 2008
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2023
• Last Updated: February 28, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)