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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
  Purpose
  1. 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).
  2. To relate pretreatment plasma EBV DNA concentration to WHO classification of these tumors both in endemic and non-endemic areas.
  3. 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:

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: Stanford University
ClinicalTrials.gov Identifier: NCT00186433     History of Changes
Other Study ID Numbers: ENT0006, ENT0006, 77622
Study First Received: September 13, 2005
Last Updated: July 5, 2012
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 May 21, 2013