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Prospective Nasopharyngeal Carcinoma Screening Using Plasma Epstein-Barr Virus DNA Analysis

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ClinicalTrials.gov Identifier: NCT02063399
Recruitment Status : Active, not recruiting
First Posted : February 14, 2014
Last Update Posted : April 18, 2017
Sponsor:
Information provided by (Responsible Party):
Allen Chan, Chinese University of Hong Kong

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 down-staging of the NPC cases in asymptomatic individuals.

Condition or disease
Nasopharyngeal Carcinoma

Detailed Description:

Epstein-Barr virus (EBV) infection is an important etiological factor for nasopharyngeal carcinoma (NPC). In a pilot study, we have shown that the analysis of Epstein-Barr virus (EBV) DNA in blood can detect early and asymptomatic NPC. However, it is unlcear if NPC screening can improve the prognosis of the screened NPC subjects.

20,000 male subjects aged from 40 to 62 will be recruited because the incidence of NPC is higher in this target group. Twenty millilitres of venous blood will be collected from each subject at enrolment for plasma EBV DNA analysis.

Subjects who have initial positive results for plasma EBV DNA will have another testing at approximately 4 weeks. Subjects who have persistently positive results for the two plasma EBV DNA analyses will be investigated using nasal endoscopic examination and MRI of the nasopharynx.

After the initial screening, all participants will be phone interviewed yearly to update their cancer status.


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Study Type : Observational
Actual Enrollment : 20302 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective 20,000-person Nasopharyngeal Carcinoma (NPC) Screening Programme Using Plasma Epstein-Barr Virus (EBV) DNA Analysis
Study Start Date : July 2013
Actual Primary Completion Date : August 2016
Estimated Study Completion Date : June 2023

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Stage distribution of nasopharyngeal carcinoma at the time of diagnosis [ Time Frame: 3 years ]
    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.


Secondary Outcome Measures :
  1. Incidence of nasopharyngeal carcinoma in screened negative group [ Time Frame: 5 years ]
    Participants who are screened negative will be followed up yearly for 5 years after the screening. The incidence of NPC will be recorded.


Biospecimen Retention:   Samples With DNA
Plasma samples are retended for future study to evaluate the accuracy of sequencing-based biomarkers


Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 62 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Male Hong Kong residents of Chinese ethnicity
Criteria

Inclusion Criteria:

  • age 40 to 62 years
  • ethnic Chinese
  • male

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02063399


Locations
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Hong Kong
Chinese University of Hong Kong
Hong Kong, Hong Kong
Sponsors and Collaborators
Chinese University of Hong Kong
Investigators
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Principal Investigator: Kwan-chee Allen Chan, MD, PhD Chinese University of Hong Kong

Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Allen Chan, Professor, Chinese University of Hong Kong
ClinicalTrials.gov Identifier: NCT02063399     History of Changes
Other Study ID Numbers: CU-ChemPath-001
First Posted: February 14, 2014    Key Record Dates
Last Update Posted: April 18, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Allen Chan, Chinese University of Hong Kong:
NPC
Cancer screening
Plasma EBV DNA

Additional relevant MeSH terms:
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Nasopharyngeal Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Nasopharyngeal Neoplasms
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Nasopharyngeal Diseases
Carcinoma
Pharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases