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Completed

NCT Number: NCT03973723

Plasma EBV DNA Monitoring in Post-treatment NPC Patients

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.

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Key information

Conditions

Nasopharyngeal Carcinoma Carcinoma EBV Head and Neck Neoplasms NPC Nasopharyngeal Diseases Nasopharyngeal Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Otorhinolaryngologic Diseases Otorhinolaryngologic Neoplasms Pharyngeal Diseases Pharyngeal Neoplasms Radiotherapy Stomatognathic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Taichung Veterans General Hospital

Taichung, 407, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Primary outcomes

  1. Time interval from the date of abnormal blood test to the date of clinically documented tumor relapse

    Time frame: Five years

    From the end of treatment to any time when abnormal blood test is fund

Secondary outcomes

  1. Overall survival (OS)

    Time frame: Five years

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

  2. Event-free survival (EFS)

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Taichung Veterans General Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2013
Study completion
2019
First posted
Jun 4, 2019
Registry last updated
Jun 7, 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.

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