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出境医 / 临床实验 / The Value of Post-radiation Detectable Plasma EBV DNA in High-risk Nasopharyngeal Carcinoma Patients

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

Study Description
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.

Condition or disease
Nasopharyngeal Carcinoma

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.

Study Design
Layout table for study information
Study Type : Observational
Actual Enrollment : 706 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official 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
Actual Study Start Date : May 2, 2012
Actual Primary Completion Date : May 1, 2013
Actual Study Completion Date : May 1, 2013
Arms and Interventions
Group/Cohort
plasma EBV DNA detectable
the NPC patient received curative treatment and post-treatment plasma EBV DNA was detectable.
plasma EBV DNA undetectable
the NPC patient received curative treatment and post-treatment plasma EBV DNA was undetectable.
Outcome Measures
Primary Outcome Measures :
  1. relapse-free survival (RFS) [ Time Frame: 5 years ]
    From the end of treatment to clinical or pathological proven disease relapse


Secondary Outcome Measures :
  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 Outcome Measures:
  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


Biospecimen Retention:   Samples With DNA
plasma EBV DNA concentrations

Eligibility Criteria
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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
locally advanced NPC patients who finished curative RT with or without chemotherapy
Criteria

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
Contacts and Locations

Sponsors and Collaborators
Taichung Veterans General Hospital
Investigators
Layout table for investigator information
Principal Investigator: Jin-Ching Lin, M.D.,PhD Taichung Veterans General Hospital
Tracking Information
First Submitted Date June 6, 2019
First Posted Date June 10, 2019
Last Update Posted Date June 10, 2019
Actual Study Start Date May 2, 2012
Actual Primary Completion Date May 1, 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 6, 2019) 		relapse-free survival (RFS) [ Time Frame: 5 years ]
From the end of treatment to clinical or pathological proven disease relapse
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: June 6, 2019) 		Overall survival (OS) [ Time Frame: 5 years ]
Overall survival was calculated from the day of enrollment until death or the last follow-up visit
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures
 (submitted: June 6, 2019)
  • 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
  • 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
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title The Value of Post-radiation Detectable Plasma EBV DNA in High-risk Nasopharyngeal Carcinoma Patients
Official 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
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.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
plasma EBV DNA concentrations
Sampling Method Probability Sample
Study Population locally advanced NPC patients who finished curative RT with or without chemotherapy
Condition Nasopharyngeal Carcinoma
Intervention Not Provided
Study Groups/Cohorts
  • plasma EBV DNA detectable
    the NPC patient received curative treatment and post-treatment plasma EBV DNA was detectable.
  • plasma EBV DNA undetectable
    the NPC patient received curative treatment and post-treatment plasma EBV DNA was undetectable.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: June 6, 2019) 		706
Original Actual Enrollment Same as current
Actual Study Completion Date May 1, 2013
Actual Primary Completion Date May 1, 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 20 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT03981224
Other Study ID Numbers CE12117-1
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party TCVGH, Taichung Veterans General Hospital
Study Sponsor Taichung Veterans General Hospital
Collaborators Not Provided
Investigators
Principal Investigator: Jin-Ching Lin, M.D.,PhD Taichung Veterans General Hospital
PRS Account Taichung Veterans General Hospital
Verification Date June 2019

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