Plasma EBV DNA Monitoring in Post-treatment NPC Patients

Long-term Results of Plasma Epstein-Barr Virus DNA Monitoring In Nasopharyngeal Carcinoma After Curative Treatment

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03973723

Enrollment

441

Registered

2019-06-04

Start date

2011-08-01

Completion date

2019-04-30

Last updated

2019-06-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

EBV, Nasopharyngeal Carcinoma, NPC, Radiotherapy

Keywords

Nasopharyngeal Carcinoma, NPC, EBV, Radiotherapy, Plasma Epstein-Barr virus DNA

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* histologically-proven nasopharyngeal carcinoma without distant metastasis (M0) at initial presentation * finished curative radiotherapy (with/without chemotherapy) within 3 years

Exclusion criteria

* no occurrence of documented recurrence/metastasis before entry

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Countries

Taiwan

Outcome results