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 April 2011 by Stanford University

First Received on September 13, 2005. Last Updated on April 11, 2011 History of Changes

Sponsor:	Stanford University
Information provided by:	Stanford University
ClinicalTrials.gov Identifier:	NCT00186433

Purpose

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.

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

Study Type:	Observational
Study Design:	Observational Model: Case Control Time Perspective: Prospective
Official Title:	A Longitudinal Study of Plasma EBV DNA in Nasopharyngeal Carcinoma From Both Endemic and Non-Endemic Patient Populations

Resource links provided by NLM:

MedlinePlus related topics: Cancer Head and Neck Cancer Oral Cancer

U.S. FDA Resources

Further study details as provided by Stanford University:

Biospecimen Retention: Samples With DNA

blood

Estimated Enrollment:	150
Study Start Date:	November 2001
Estimated Study Completion Date:	November 2013
Estimated Primary Completion Date:	November 2012 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Having a new diagnosis of Nasopharyngeal carcinoma

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00186433

Contacts

Contact: Quynh-Thu Le

(650) 498-6184

qle@stanford.edu

Locations

United States, California
Stanford University School of Medicine	Recruiting
Stanford, California, United States, 94305
Contact: Quynh-Thu Le 650-498-6184 qle@stanford.edu
Contact: Cancer Clinical Trials Office (650) 498-7061
Principal Investigator: Quynh-Thu Le
Sub-Investigator: Harlan Pinto
Sub-Investigator: James L Zehnder
Sub-Investigator: Dr. Billy W. Loo Jr. M.D. Ph.D.

Sponsors and Collaborators

Stanford University

Investigators

Principal Investigator:

Quynh-Thu Le

Stanford University

More Information

No publications provided

Responsible Party:	Quynh-Thu Le, Stanford University School of Medicine
ClinicalTrials.gov Identifier:	NCT00186433 History of Changes
Other Study ID Numbers:	ENT0006, ENT0006, 77622
Study First Received:	September 13, 2005
Last Updated:	April 11, 2011
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Neoplasms
Carcinoma
Head and Neck Neoplasms
Lip Neoplasms
Mouth Neoplasms
Nasopharyngeal Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms by Site

Lip Diseases
Mouth Diseases
Stomatognathic Diseases
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Nasopharyngeal Diseases
Pharyngeal Diseases
Otorhinolaryngologic Diseases

ClinicalTrials.gov processed this record on February 09, 2012