Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
87600 participants
INTERVENTIONAL
2008-01-31
2023-12-31
Brief Summary
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Detailed Description
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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
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SCREENING
SINGLE
Study Groups
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intervention
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.
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.
Control
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.
No interventions assigned to this group
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Exclusion Criteria
30 Years
69 Years
ALL
Yes
Sponsors
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Cancer Research Institute of Zhongshan City
OTHER_GOV
Sihui Cancer Institute
OTHER
Sun Yat-sen University
OTHER
Responsible Party
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Hong Ming-huang
Professor
Principal Investigators
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Minghuang Hong, M.D
Role: PRINCIPAL_INVESTIGATOR
Sun Yat-sen University
Locations
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Sihui Cancer Institute
Sihui, Guangdong, China
Cancer Research Institute of Zhongshan City
Zhongshan, Guangdong, China
Countries
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References
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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.
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.
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.
Other Identifiers
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CRCSTNPC
Identifier Type: -
Identifier Source: org_study_id
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