Plasma EBV DNA Monitoring in Post-treatment NPC Patients

Completed

• Conditions: EBV; Radiotherapy; NPC; Nasopharyngeal Carcinoma

• Registration Number: NCT03973723
• Lead Sponsor: Taichung Veterans General Hospital

Brief Summary

Continuous regular monitoring of plasma EBV DNA in nasopharyngeal carcinoma (NPC) after treatment have rarely been investigated. The investigators try to analyze the long-term observational results (role in early relapse detection and impact on survival) in NPC patients after curative treatment.

Detailed Description

The investigators enrolled 441 NPC patients who had finished finished curative radiotherapy with/without chemotherapy and no recurrence/metastasis before entry this study from five hospitals in Taiwan. Blood samples were collected on the day of enrollment and monitored once every 2-3 months for plasma EBV DNA measurement. After long-term observation, we analyze the impact of continuous plasma EBV DNA monitoring on the early dection of tumor relapse and do risk grouping for survival analyses according to the blood test results.

Study Timeline

• Study Start: 2011-08-01
• Primary Completion: 2013-12-31
• Study Completion: 2019-04-30
• Status Verified: 2019-06
• Study First Submitted: 2019-06-03
• Study First Submitted QC: 2019-06-03
• Study First Posted: 2019-06-04
• Last Update Submitted: 2019-06-06
• Last Update Posted: 2019-06-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 441

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Time interval from the date of abnormal blood test to the date of clinically documented tumor relapse	Five years	From the end of treatment to any time when abnormal blood test is fund

Secondary Outcome Measures

Name	Time	Method
Overall survival (OS)	Five years	Overall survival was calculated from the day of enrollment until death or the last follow-up visit
Event-free survival (EFS)	Five years	Event-free survival was calculated from the day of enrollment until the date of first occurrence of tumor relapse (local, regional, or distant failures) or the last follow-up visit

Trial Locations

Locations (1)

Taichung Veterans General Hospital; 🇨🇳 Taichung, Taiwan