Prospective Nasopharyngeal Carcinoma Screening Using Plasma Epstein-Barr Virus DNA Analysis
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02063399|
Recruitment Status : Active, not recruiting
First Posted : February 14, 2014
Last Update Posted : April 18, 2017
|Condition or disease|
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.
|Study Type :||Observational|
|Actual Enrollment :||20302 participants|
|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|
- 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.
- 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
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
|Chinese University of Hong Kong|
|Hong Kong, Hong Kong|
|Principal Investigator:||Kwan-chee Allen Chan, MD, PhD||Chinese University of Hong Kong|