Skip to main content
OpenTrials
Completed

NCT Number: NCT03981224

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Nasopharyngeal Carcinoma Carcinoma DNA Virus Infections Epstein-Barr Virus Infections Head and Neck Neoplasms Herpesviridae Infections Infections Nasopharyngeal Diseases Nasopharyngeal Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Otorhinolaryngologic Diseases Otorhinolaryngologic Neoplasms Pharyngeal Diseases Pharyngeal Neoplasms Stomatognathic Diseases Tumor Virus Infections Virus Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. relapse-free survival (RFS)

    Time frame: 5 years

    From the end of treatment to clinical or pathological proven disease relapse

Secondary outcomes

  1. Overall survival (OS)

    Time frame: 5 years

    Overall survival was calculated from the day of enrollment until death or the last follow-up visit

Other outcomes

  1. locoregional failure-free survival (LRFFS)

    Time frame: 5 years

    locoregional failure-free survival was calculated from the day of enrollment until locoregional failure or the last follow-up visit

  2. distant metastasis failure-free survival (DMFFS)

    Time frame: 5 years

    distant metastasis failure-free survival was calculated from the day of enrollment until distant metastasis or the last follow-up visit

Sponsors and collaborators

Lead sponsor

Taichung Veterans General Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Jun 10, 2019
Registry last updated
Jun 10, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.