A Longitudinal Study of Plasma EBV DNA in Nasopharyngeal... | NCT00186433

Studies
A Longitudinal Study of Plasma EBV DNA in Nasopharyngeal Carcinoma From Both Endemic and Non-Endemic Patient Populations

NCT00186433

Sponsor

Stanford University

Status

Completed

Last Update Posted

May 27, 2015Estimated

Enrollment

49Actual

Phase

Not provided

Conditions

Mouth Cancer
Lip Cancer
Throat Cancer
Lip Neoplasms
Head and Neck Cancers

Interventions

Not provided

Countries

United States

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

ID	Type	Description	Link
ENT0006	Other Identifier	Stanford University
77622	Other Identifier	Stanford University Alternate IRB Approval Number

Status Module

Record Verification Date

May 2015

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

Nov 2001

Primary Completion Date

Jun 2013Actual

Completion Date

Jun 2013Actual

First Submitted Date

Sep 13, 2005

First Submission Date that Met QC Criteria

Sep 13, 2005

First Posted Date

Sep 16, 2005Estimated

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

May 22, 2015

Last Update Posted Date

May 27, 2015Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Quynh-Thu Le, Katharine Dexter McCormick and Stanley McCormick Memorial Professor, Stanford UniversityPrincipal Investigator

Lead Sponsor

Stanford UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

To determine the prognostic implication of plasma Epstein-Bar Virus (EBV) DNA concentrations, as measured by quantitative polymerase chain reaction (PCR) in patients with nasopharyngeal carcinoma (NPC).
To relate pretreatment plasma EBV DNA concentration to WHO classification of these tumors both in endemic and non-endemic areas.
To determine whether pretreatment plasma EBV DNA can serve as a prognostic factor for both endemic and non-endemic patient populations.

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

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

49Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Plasma Epstein-Bar Virus (EBV) DNA concentrations	measured by quantitative polymerase chain reaction (PCR)	every 6 months until end of study

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Having a new diagnosis of Nasopharyngeal carcinoma.
Being treated with either radiotherapy or chemoradiotherapy for this condition.

Exclusion Criteria:

Age <18 since NPC is a very rare condition in this age group and may have a different biological behavior
Patients who are unable to provide informed consents for themselves.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Having a new diagnosis of Nasopharyngeal carcinoma

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Quynh-Thu Le	Stanford University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Stanford University School of Medicine		Stanford	California	94305	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
23459720	Derived	Le QT, Zhang Q, Cao H, Cheng AJ, Pinsky BA, Hong RL, Chang JT, Wang CW, Tsao KC, Lo YD, Lee N, Ang KK, Chan AT, Chan KC. An international collaboration to harmonize the quantitative plasma Epstein-Barr virus DNA assay for future biomarker-guided trials in nasopharyngeal carcinoma. Clin Cancer Res. 2013 Apr 15;19(8):2208-15. doi: 10.1158/1078-0432.CCR-12-3702. Epub 2013 Mar 4.

ID	Term
D009062	Mouth Neoplasms
D008048	Lip Neoplasms
D006258	Head and Neck Neoplasms

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D009059	Mouth Diseases
D009057	Stomatognathic Diseases