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

This study is currently recruiting participants.

Verified July 2012 by Stanford University

Sponsor:

Information provided by (Responsible Party):

Stanford University

ClinicalTrials.gov Identifier:

NCT00186433

First received: September 13, 2005

Last updated: July 5, 2012

Last verified: July 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

September 13, 2005

Last Updated Date

July 5, 2012

Start Date ^ICMJE

November 2001

Estimated Primary Completion Date

November 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Not Provided

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00186433 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Case Control
Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Retention: Samples With DNA

Description:

blood

Sampling Method

Non-Probability Sample

Study Population

Having a new diagnosis of Nasopharyngeal carcinoma

Condition ^ICMJE

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

Intervention ^ICMJE

Not Provided

Study Group/Cohort (s)

Not Provided

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 ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

150

Estimated Completion Date

November 2013

Estimated Primary Completion Date

November 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Quynh-Thu Le

(650) 498-6184

qle@stanford.edu

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00186433

Other Study ID Numbers ^ICMJE

ENT0006, ENT0006, 77622

Has Data Monitoring Committee

Yes

Responsible Party

Stanford University

Study Sponsor ^ICMJE

Stanford University

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Quynh-Thu Le

Stanford University

Information Provided By

Stanford University

Verification Date

July 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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