Plasma EBV DNA Monitoring in Post-treatment NPC Patients

June 6, 2019 updated by: Taichung Veterans General Hospital

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

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

441

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taichung, Taiwan, 407
        • Taichung Veterans General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

The patients with NPC who were treated at 5 hospitals (Taichung Veterans General Hospital, Taichung; Yuan's General Hospital, Kaohsiung; National Cheng Kung University Hospital, Tainan; Kaohsiung Medical University Hospital, Kaohsiung; Taipei Medical University Hospital, Taipei; Taiwan)

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Patients with NPC after treatment
All patients with NPC without distant metastases who receiving adequate RT dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Five years

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Taichung Veterans General Hospital

Investigators

  • Principal Investigator: Jin-Ching Lin, M.D.,PhD, Taichung Veterans General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2011

Primary Completion (Actual)

December 31, 2013

Study Completion (Actual)

April 30, 2019

Study Registration Dates

First Submitted

June 3, 2019

First Submitted That Met QC Criteria

June 3, 2019

First Posted (Actual)

June 4, 2019

Study Record Updates

Last Update Posted (Actual)

June 7, 2019

Last Update Submitted That Met QC Criteria

June 6, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CG11133

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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