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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00186433
First Posted: September 16, 2005
Last Update Posted: May 27, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Quynh-Thu Le, Stanford University
  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:


Further study details as provided by Quynh-Thu Le, Stanford University:

Primary Outcome Measures:
  • Plasma Epstein-Bar Virus (EBV) DNA concentrations [ Time Frame: every 6 months until end of study ]
    measured by quantitative polymerase chain reaction (PCR)


Biospecimen Retention:   Samples With DNA
blood

Enrollment: 49
Study Start Date: November 2001
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00186433


Locations
United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: Quynh-Thu Le Stanford University
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Quynh-Thu Le, Katharine Dexter McCormick and Stanley McCormick Memorial Professor, Stanford University
ClinicalTrials.gov Identifier: NCT00186433     History of Changes
Other Study ID Numbers: ENT0006
ENT0006 ( Other Identifier: Stanford University )
77622 ( Other Identifier: Stanford University Alternate IRB Approval Number )
First Submitted: September 13, 2005
First Posted: September 16, 2005
Last Update Posted: May 27, 2015
Last Verified: May 2015

Additional relevant MeSH terms:
Head and Neck Neoplasms
Nasopharyngeal Neoplasms
Mouth Neoplasms
Lip Neoplasms
Neoplasms by Site
Neoplasms
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Nasopharyngeal Diseases
Pharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases
Mouth Diseases
Lip Diseases