NCT05447169

Brief Summary

The investigators intend to compare Epstein-Barr virus antibody and Epstein-Barr virus DNA screening efficacy in first-degree relatives of nasopharyngeal carcinoma patients.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
11,625

participants targeted

Target at P75+ for all trials

Timeline
50mo left

Started Jul 2022

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

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 Progress48%
Jul 2022Jul 2030

First Submitted

Initial submission to the registry

July 2, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 7, 2022

Completed
3 days until next milestone

Study Start

First participant enrolled

July 10, 2022

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2025

Completed
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2030

Expected
Last Updated

July 8, 2022

Status Verified

July 1, 2022

Enrollment Period

3 years

First QC Date

July 2, 2022

Last Update Submit

July 6, 2022

Conditions

Nasopharyngeal Carcinoma

Keywords

Nasopharyngeal Carcinoma ScreenEBV DNAEBV antibody

Outcome Measures

Primary Outcomes (2)

  • positive predictive value

    the ratio of subjects truly diagnosed as nasopharyngeal carcinoma to all those who had positive test results

    3 years

  • negative predictive value

    the ratio of subjects truly diagnosed as negative (do not have nasopharyngeal carcinoma) to all those who had negative test results

    3 years

Secondary Outcomes (4)

  • sensitivity

    3 years

  • specificity

    3 years

  • early diagnose rate

    3 years

  • cost-effectiveness

    3 years

Study Arms (1)

High risk population of nasopharyngeal carcinoma

first-degree relatives of nasopharyngeal carcinoma patients, aged 30-62 male

Diagnostic Test: EBV antibodies testDiagnostic Test: EBV DNA test

Interventions

EBV antibodies testDIAGNOSTIC_TEST

ELISA test of VCA-IgA，EBNA1-IgA，EA-IgA， Zta-IgA ，Rta-IgG and BNLF 2b in nasopharyngeal brushing and plasma

High risk population of nasopharyngeal carcinoma
EBV DNA testDIAGNOSTIC_TEST

quantitative polymerase chain reaction, CRISPR-associated protein 12a and target sequencing of EBV DNA in nasopharyngeal brushing and plasma

High risk population of nasopharyngeal carcinoma

Eligibility Criteria

Age30 Years - 62 Years
Sexmale
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Residences in Southern China

You may qualify if:

  • residents in Southern China
  • years old
  • male
  • a first-degree relative of at least one nasopharyngeal carcinoma patient
  • no medical record of nasopharyngeal carcinoma
  • Eastern Cooperative Oncology Group score of 0-2
  • be able to comprehend, sign, and date the written informed consent document to participate in the study

You may not qualify if:

  • history of nasopharyngeal carcinoma
  • heavy cardiovascular, liver or kidney disease
  • on systemic steroid or immunosuppressant treatment or active autoimmune disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

nasopharyngeal brushing and peripheral blood

MeSH Terms

Conditions

Nasopharyngeal Carcinoma

Condition Hierarchy (Ancestors)

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

Study Officials

  • Ming-Yuan Chen, MD, PhD

    Sun Yat-sen University

    STUDY CHAIR

Central Study Contacts

Ming-Yuan Chen, MD, PhD

CONTACT

86-20-8734-3361chmingy@mail.sysu.edu.cn

Si-Yuan Chen, MD

CONTACT

86-18711150216chensy@sysucc.org.cn

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor & chief physician

Study Record Dates

First Submitted

July 2, 2022

First Posted

July 7, 2022

Study Start

July 10, 2022

Primary Completion

July 1, 2025

Study Completion (Estimated)

July 1, 2030

Last Updated

July 8, 2022

Record last verified: 2022-07

Locations

CN(1)