Reproducibility and Reliability of Epstein-Barr Virus (EB... | NCT01972815

Studies
Reproducibility and Reliability of Epstein-Barr Virus (EBV) DNA/RNA Measures in Nasopharyngeal Swabs

NCT01972815

Sponsor

National Taiwan University Hospital

Status

Unknown status

Last Update Posted

Oct 30, 2013Estimated

Enrollment

100Estimated

Phase

Not provided

Conditions

Suspect NPC Patients
NPC Multiplex Families

Interventions

Not provided

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

Oct 2013

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

Oct 2012

Primary Completion Date

Oct 2012Actual

Completion Date

Not provided

First Submitted Date

Oct 24, 2013

First Submission Date that Met QC Criteria

Oct 29, 2013

First Posted Date

Oct 30, 2013Estimated

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

Oct 29, 2013

Last Update Posted Date

Oct 30, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

Nasopharyngeal carcinoma (NPC) is a virus-associated cancer that is rare among Caucasians but occurs at an elevated rate among Southern Asians. Rates of NPC are particularly high among individuals with a family history of this disease, but no specific genetic factors have been identified that can serve to guide clinical management of this high-risk population to ensure early detection and treatment of this life-threatening condition.

Detailed Description

Not provided

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

No data available

No data is available for this block.

Enrollment

100Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
positive agreement among the positives, coefficient of variation		Four years
positive agreement among the positives, coefficient of variation	CV=SD/mean * 100	four years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

suspect NPC patients

Exclusion Criteria:

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

suspect NPC patients

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Pei-Jen Lou	Contact	+886-23123456	65224	pjlou@ntu.edu.tw

Overall Officials

Name	Affiliation	Role
Pei-Jen Lou	National Taiwan University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Nation Taiwan University Hospital	Recruiting	Taipei			Taiwan