The Value of Post-radiation Detectable Plasma EBV DNA in High-risk Nasopharyngeal Carcinoma Patients

Additional Blood Test Enhances Diagnostic Sensitivity of Relapse Detection and Predicts Survivals in High-risk Nasopharyngeal Carcinoma Patients With Post-radiation Detectable Plasma EBV DNA

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03981224

Enrollment

706

Registered

2019-06-10

Start date

2012-05-02

Completion date

2013-05-01

Last updated

2019-06-10

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

Conditions

Nasopharyngeal Carcinoma

Keywords

Nasopharyngeal carcinoma, Radiotherapy, Epstein-Barr virus

Brief summary

An additional blood test at 2-3 months after RT is a valuable biomarker in predicting treatment outcome for NPC patients. Patients with persistently detectable EBV DNA during re-staging survey 2-3 months after RT should strengthen adjuvant therapy due to very high subsequent relapse rate and poor survivals.

Detailed description

One week post-radiation therapy (RT) blood test showing persistently detectable EBV DNA is a very poor prognostic factor for nasopharyngeal carcinoma (NPC) patients. We hypothesize that additional EBV DNA confirmation test could enhance diagnostic sensitivity of relapse detection and predict survivals. We screened 706 newly diagnosed NPC patients who finished curative RT with or without chemotherapy from March 2001 to December 2012. Additional EBV DNA blood test was performed at re-staging survey 2-3 months after RT. The association between treatment outcome (tumor relapse and patients' survival) and this additional blood test along with various clinical parameters were analyzed.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

* histologically-proven nasopharyngeal carcinoma without distant metastasis (M0) at initial presentation * NPC patients who finished curative RT with or without chemotherapy

Exclusion criteria

* initial present M1 disease * Secondary primary cancer diagnosed within 5 years * performance status (WHO scale) less than 2

Design outcomes

Primary

Measure	Time frame	Description
relapse-free survival (RFS)	5 years	From the end of treatment to clinical or pathological proven disease relapse

Secondary

Measure	Time frame	Description
Overall survival (OS)	5 years	Overall survival was calculated from the day of enrollment until death or the last follow-up visit

Other

Measure	Time frame	Description
locoregional failure-free survival (LRFFS)	5 years	locoregional failure-free survival was calculated from the day of enrollment until locoregional failure or the last follow-up visit
distant metastasis failure-free survival (DMFFS)	5 years	distant metastasis failure-free survival was calculated from the day of enrollment until distant metastasis or the last follow-up visit

Outcome results