NCT02063399

Brief Summary

The purpose of this study is to determine if the screening of nasopharyngeal carcinoma using plasma Epstein-Barr virus DNA analysis would result in the detecting NPC cases at earlier stages and improve survival.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
20,302

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2013

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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 Start

First participant enrolled

July 1, 2013

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

February 13, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 14, 2014

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
6.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2023

Completed
Last Updated

October 17, 2022

Status Verified

October 1, 2022

Enrollment Period

3.1 years

First QC Date

February 13, 2014

Last Update Submit

October 13, 2022

Conditions

Nasopharyngeal Carcinoma

Keywords

NPCCancer screeningPlasma EBV DNA

Outcome Measures

Primary Outcomes (1)

  • Stage distribution of nasopharyngeal carcinoma at the time of diagnosis

    All the participants will be subjected to the screening of nasopharyngeal carcinoma (NPC) at the time of recruitment using plasma EBV DNA analysis. Subjects with positive results will be investigated using endoscopic examination and MRI. If the subject is confirmed of having NPC, the stage of the disease would be recorded.

    3 years

Secondary Outcomes (2)

  • Incidence of nasopharyngeal carcinoma in screened negative group

    5 years

  • Relative risk of developing nasopharyngeal carcinoma for subjects with positive test results

    5 years

Eligibility Criteria

Age40 Years - 62 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Male Hong Kong residents of Chinese ethnicity

You may qualify if:

  • age 40 to 62 years
  • ethnic Chinese
  • male

You may not qualify if:

  • history of nasopharyngeal carcinoma
  • currently having a malignant disease
  • active autoimmune disease
  • HIV infection
  • on systemic steroid treatment
  • on immunosuppressant treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chinese University of Hong Kong

Hong Kong, Hong Kong

Location

Related Publications (4)

  • Chan KC, Hung EC, Woo JK, Chan PK, Leung SF, Lai FP, Cheng AS, Yeung SW, Chan YW, Tsui TK, Kwok JS, King AD, Chan AT, van Hasselt AC, Lo YM. Early detection of nasopharyngeal carcinoma by plasma Epstein-Barr virus DNA analysis in a surveillance program. Cancer. 2013 May 15;119(10):1838-44. doi: 10.1002/cncr.28001. Epub 2013 Feb 21.

    PMID: 23436393BACKGROUND

  • Lo YM, Chan LY, Lo KW, Leung SF, Zhang J, Chan AT, Lee JC, Hjelm NM, Johnson PJ, Huang DP. Quantitative analysis of cell-free Epstein-Barr virus DNA in plasma of patients with nasopharyngeal carcinoma. Cancer Res. 1999 Mar 15;59(6):1188-91.

    PMID: 10096545BACKGROUND

  • Chan KCA, Lam WKJ, King A, Lin VS, Lee PPH, Zee BCY, Chan SL, Tse IOL, Tsang AFC, Li MZJ, Jiang P, Ai QYH, Poon DMC, Au KH, Hui EP, Ma BBY, Van Hasselt AC, Chan ATC, Woo JKS, Lo YMD. Plasma Epstein-Barr Virus DNA and Risk of Future Nasopharyngeal Cancer. NEJM Evid. 2023 Jul;2(7):EVIDoa2200309. doi: 10.1056/EVIDoa2200309. Epub 2023 Jun 27.

    PMID: 38320164DERIVED

  • Chan KCA, Woo JKS, King A, Zee BCY, Lam WKJ, Chan SL, Chu SWI, Mak C, Tse IOL, Leung SYM, Chan G, Hui EP, Ma BBY, Chiu RWK, Leung SF, van Hasselt AC, Chan ATC, Lo YMD. Analysis of Plasma Epstein-Barr Virus DNA to Screen for Nasopharyngeal Cancer. N Engl J Med. 2017 Aug 10;377(6):513-522. doi: 10.1056/NEJMoa1701717.

    PMID: 28792880DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Plasma samples are retended for future study to evaluate the accuracy of sequencing-based biomarkers

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

  • Kwan-chee Allen Chan, MD, PhD

    Chinese University of Hong Kong

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 13, 2014

First Posted

February 14, 2014

Study Start

July 1, 2013

Primary Completion

August 1, 2016

Study Completion

June 1, 2023

Last Updated

October 17, 2022

Record last verified: 2022-10

Locations

HK(1)