NCT04085900

Brief Summary

All participants will be tested for EBV associated biomarkers, including EBNA1-IgA, VCA-IgA, BNLF2b total antibodies (P85-Ab) et al. For all male participants and P85-Ab positive female participants, EBV DNA in plasma will be tested. Screening positive participants will be followed up annually. All subjects will also be followed by record linkage to Cancer Register and Population Register.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40,000

participants targeted

Target at P75+ for all trials

Timeline
20mo left

Started Apr 2020

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress79%
Apr 2020Dec 2027

First Submitted

Initial submission to the registry

September 9, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 11, 2019

Completed
7 months until next milestone

Study Start

First participant enrolled

April 1, 2020

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Expected
Last Updated

July 13, 2023

Status Verified

July 1, 2023

Enrollment Period

4.8 years

First QC Date

September 9, 2019

Last Update Submit

July 12, 2023

Conditions

Nasopharyngeal Carcinoma

Keywords

ScreeningNasopharyngeal CarcinomaBiomarker

Outcome Measures

Primary Outcomes (2)

  • Sensitivity and specificity of different EBV associated biomarkers

    To compare the sensitivity and specificity of different EBV associated biomarkers for NPC

    5 years

  • Positive and negative predictive values of different EBV associated biomarkers

    To compare the positive and negative predictive values of different EBV associated biomarkers for NPC

    5 years

Secondary Outcomes (2)

  • Number needed to screen to identify one nasopharyngeal carcinoma

    5 years

  • Early diagnosis rate of nasopharyngeal carcinoma

    5 years

Other Outcomes (2)

  • The health economic benefits of different biomarkers for nasopharyngeal carcinoma

    5 years

  • New screening strategy of nasopharyngeal carcinoma screening

    5 years

Study Arms (1)

Screening cohort

30-69 years old healthy participants in Zhongshan and Wuzhou.

Biological: Blood and salivaDiagnostic Test: P85-Ab, EBNA1-IgA, VCA-IgA and EBV DNADiagnostic Test: Fiberoptic endoscopy and biopsy

Interventions

Blood and salivaBIOLOGICAL

Collect blood and saliva samples from participants

Screening cohort
P85-Ab, EBNA1-IgA, VCA-IgA and EBV DNADIAGNOSTIC_TEST

Detect P85-Ab, EBNA1-IgA, VCA-IgA for all participants, and detect EBV DNA for all male participants and P85-Ab positive female participants.

Screening cohort
Fiberoptic endoscopy and biopsyDIAGNOSTIC_TEST

Screening participants will refer to fiberoptic endoscopy and biospy

Screening cohort

Eligibility Criteria

Age30 Years - 69 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

30-69 years old healthy residences in Zhongshan City and Wuzhou City.

You may qualify if:

  • Subject residents in Zhongshan City or Wuzhou City
  • Subject has no medical record of nasopharyngeal carcinoma
  • ECOG 0-2
  • Subject is able to comprehend, sign, and date the written informed consent document to participate in the study.
  • Subject has psychical condition and well consciousness, and also accept and cooperate with the follow-up of this study.

You may not qualify if:

  • Subject has heavy cardiovascular, liver or kidney disease.
  • Subject has contraindications to nasopharyngeal fiberoptic endoscopy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Zhongshan People's Hospital

Zhongshan, Guangdong, 528403, China

RECRUITING

Wuzhou Red Cross Hospital

Wuzhou, Guangxi, 543002, China

RECRUITING

Related Publications (1)

  • Li T, Li F, Guo X, Hong C, Yu X, Wu B, Lian S, Song L, Tang J, Wen S, Gao K, Hao M, Cheng W, Su Y, Zhang S, Huang S, Fang M, Wang Y, Ng MH, Chen H, Luo W, Ge S, Zhang J, Xia N, Ji M. Anti-Epstein-Barr Virus BNLF2b for Mass Screening for Nasopharyngeal Cancer. N Engl J Med. 2023 Aug 31;389(9):808-819. doi: 10.1056/NEJMoa2301496.

    PMID: 37646678DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Blood and saliva samples

MeSH Terms

Conditions

Nasopharyngeal Carcinoma

Interventions

Blood Specimen CollectionBiopsy

Condition Hierarchy (Ancestors)

CarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsNasopharyngeal NeoplasmsPharyngeal NeoplasmsOtorhinolaryngologic NeoplasmsHead and Neck NeoplasmsNeoplasms by SiteNasopharyngeal DiseasesPharyngeal DiseasesStomatognathic DiseasesOtorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative TechniquesCytodiagnosisCytological TechniquesDiagnostic Techniques, Surgical

Study Officials

  • Mingfang Ji, MD

    Zhongshan People's Hospital, Guangdong, China

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mingfang Ji, MD

CONTACT

86-760-89880417jmftbh@sina.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
5 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. Mingfang Ji

Study Record Dates

First Submitted

September 9, 2019

First Posted

September 11, 2019

Study Start

April 1, 2020

Primary Completion

December 31, 2024

Study Completion (Estimated)

December 31, 2027

Last Updated

July 13, 2023

Record last verified: 2023-07

Locations

CN(2)