AzTrials
AzTrials

Nasopharyngeal CancerCRCSTNPCNCT00941538

Cluster Randomized Controlled Screening Trial for NPC

A study testing Experimental: Screening with EBV VCA/EBNA1-IgA testing in people with Nasopharyngeal Cancer and Screening, run by Sun Yat-sen University at 2 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 30 to 69 yearsHealthy volunteers can take part
Conditions the study is for
Nasopharyngeal Cancer, Screening, Morality
What is being tested?
Experimental: Screening with EBV VCA/EBNA1-IgA testing
Could I receive a placebo?
No, everyone receives an active treatment
How many people
87,600 participants
Where
2 sitesChina
Study dates
Jan 2008to Dec 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 to 69 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

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.

Trial locations and contacts

2 sites in 1 country.

China2 sites

  • Sihui Cancer Institute

    Sihui, Guangdong

  • Cancer Research Institute of Zhongshan City

    Zhongshan, Guangdong

Other trials in China

About this study

Official title: A Cluster Randomized Controlled Screening Trial for Nasopharyngeal Carcinoma in Southern China (CRCSTNPC Study)

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.

Read the 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

Being tested
Experimental: Screening with EBV VCA/EBNA1-IgA testing
Keywords
nasopharyngeal cancer, screening, early detection, mortality, randomized control trial, Epstain-Barr Virus
Medical subject headings
Nasopharyngeal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Experimental: Screening with EBV VCA/EBNA1-IgA testingDiagnostic test

    Also called Diagnostic work-up using fiberoptic endoscopy examination and/or nasopharyngeal biopsies

    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.

Study groups in NCT00941538
Study groupRoleWhat they receive
interventionExperimentalResidents 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.
Receives: Diagnostic Test: Experimental: Screening with EBV VCA/EBNA1-IgA testing
ControlNo interventionThe 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: December, 2019

Secondary outcomes (5)

  1. All-cause mortality at 12 years by intervention group

    All-cause mortality rate will be compared between screening group and control group at 12-year follow-up.

    Measured: December, 2019

  2. NPC incidence at 12 years by intervention group

    NPC incidence rate will be compared between screening group and control group at 12-year follow-up.

    Measured: December, 2019

  3. Stage distribution at diagnosis for NPC patients by intervention group

    Stage distribution will be compared between screening group and control group at 12-year follow-up.

    Measured: December, 2019

  4. NPC overall survival by cases from the two intervention groups

    Survival rate will be compared between screening group and control group at 12-year follow-up.

    Measured: December, 2019

  5. Cost-effectiveness

    Cost-effectiveness of this screening program will be calculated at 12-year follow-up.

    Measured: December, 2019

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Jul 2009 (estimated)
  2. Study startJan 2008
  3. Primary completionDec 2019
  4. Study completionDec 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Screening
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
87,600 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00941538
Sponsor's protocol ID
CRCSTNPC
Acronym
CRCSTNPC
Status last verified
Feb 2023
First submitted
16 Jul 2009
Last updated
28 Feb 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 39353160

  • 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.

    PubMed 31373615

  • 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.

    PubMed 23255783

Questions about this trial

What is this clinical trial studying?

A study testing Experimental: Screening with EBV VCA/EBNA1-IgA testing in people with Nasopharyngeal Cancer and Screening, run by Sun Yat-sen University at 2 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 28 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mortality rate of NPC at 12 years by intervention group (time frame: December, 2019). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00941538, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2023.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in