The Value of Post-radiation Detectable Plasma EBV DNA in... | NCT03981224

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

NCT03981224

Sponsor

Taichung Veterans General Hospital

Status

Completed

Last Update Posted

Jun 10, 2019Actual

Enrollment

706Actual

Phase

Not provided

Conditions

Nasopharyngeal Carcinoma

Interventions

Not provided

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2, 2012Actual

Primary Completion Date

May 1, 2013Actual

Completion Date

May 1, 2013Actual

First Submitted Date

Jun 6, 2019

First Submission Date that Met QC Criteria

Jun 6, 2019

First Posted Date

Jun 10, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 6, 2019

Last Update Posted Date

Jun 10, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

706Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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.

Interventions

Not provided

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

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

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

locally advanced NPC patients who finished curative RT with or without chemotherapy

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jin-Ching Lin, M.D.,PhD	Taichung Veterans General Hospital	Principal Investigator

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000077274	Nasopharyngeal Carcinoma
D020031	Epstein-Barr Virus Infections

Ancestor Terms

ID	Term
D002277	Carcinoma
D009375	Neoplasms, Glandular and Epithelial
D009370	Neoplasms by Histologic Type
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided