Effect of the Plasma EBV DNA Change During Chemoradiother... | NCT03087695

Studies
Effect of the Plasma EBV DNA Change During Chemoradiotherapy in Nasopharyngeal Carcinoma

NCT03087695

Sponsor

Taichung Veterans General Hospital

Status

Unknown status

Last Update Posted

Mar 22, 2017Actual

Enrollment

200Estimated

Phase

Not provided

Conditions

Nasopharyngeal Carcinoma

Interventions

Plasma EBV DNA

Countries

Taiwan

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

Mar 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 1, 2017Estimated

Primary Completion Date

Jan 16, 2018Estimated

Completion Date

Jan 16, 2019Estimated

First Submitted Date

Mar 6, 2017

First Submission Date that Met QC Criteria

Mar 16, 2017

First Posted Date

Mar 22, 2017Actual

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

Mar 16, 2017

Last Update Posted Date

Mar 22, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

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

Epstein-Barr virus (EBV) has been proven to process a strong association in patient of nasopharyngeal carcinoma (NPC). Monitoring plasma EBV DNA in NPC patients can provide reliable informations in early detecting tumor recurrence or risk grouping.

Detailed Description

EBV DNA has strongly association in NPC patient' disease status. It can provide informations of disease relapse or risks classification. In this study, we will investigate the impact of plasma EBV DNA concentration change during chemoradiotherapy on initial tumor response and long-term survival in patients with advanced nasopharyngeal carcinoma

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

200Estimated

Name	Type	Description	Arm Group Labels	Other Names
Plasma EBV DNA	Diagnostic Test	Parameters analyzed will include (1) the change pattern of plasma EBV DNA concentrations, (2) various half-life values (t1/2) of plasma EBV DNA clearance rate calculated over different time periods.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Overall survival (OS)	Survival calculation	2 years

Secondary Outcomes

Measure	Description	Time Frame
Progression free survival (PFS)	Survival calculation	2 years
Nasopharynx failure-free survival (NPFFS)	Survival calculation	2 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Histological proven NPC.
2010 American Joint Committee on Cancer (AJCC) stage II-IVB.
Age ≧ 20 years old.
Performance status of Eastern Cooperative Oncology Group (ECOG) ≦ 2.
Adequate liver, renal, and bone marrow functions 5.1 Serum total bilirubin level ≦ 2.5 mg/dl. 5.2 Serum creatinine ≦ 1.6 mg/dl or calculated creatinine clearance rate (CCr) ≧ 60 cc/min.

5.3 White blood cell count (WBC) ≧ 3,000/micro-ml. 5.4 Platelet count ≧ 100,000/micro-ml.
Pre-treatment plasma EBV DNA > 0 copies/mL
Signed informed consent.

Exclusion Criteria:

Presence of distant metastasis.
Previous radiotherapy or chemotherapy.
History of a malignancy except those treated with curative intent for skin cancer (other than melanoma), in situ cervical cancer, ductal carcinoma in situ (DCIS) of the breast.
Severe cardiopulmonary diseases (unstable angina and/or congestive heart failure or peripheral vascular disease requiring hospitalization within the last 12 months; chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization) or clinically significant psychiatric disorders.
Female patients who are pregnant or lactating.

Accepts Healthy Volunteers

Not provided

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

Nasopharyngeal carcinoma patient received definite treatment in Taichung Veteran General Hospital

Sampling Method

Probability Sample

Name	Role	Phone	Extension	Email
Jin-Ching Lin, MD, PhD	Contact	+886-4-23592525	5613	jclin@vghtc.gov.tw
Yi-Chun Liu, MD	Contact	+886-4-23592525	5621	b9202080@gmail.com

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