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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:
Information provided by (Responsible Party):
Stanford University
ClinicalTrials.gov Identifier:
NCT00186433
First received: September 13, 2005
Last updated: June 11, 2013
Last verified: June 2013
  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 Stanford University:

Primary Outcome Measures:
  • Plasma Epstein-Bar Virus (EBV) DNA concentrations [ Time Frame: every 6 months until end of study ] [ Designated as safety issue: No ]
    measured by quantitative polymerase chain reaction (PCR)


Biospecimen Retention:   Samples With DNA

blood


Estimated Enrollment: 150
Study Start Date: November 2001
Study Completion Date: June 2013
Primary Completion Date: June 2013 (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
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, see Learn About Clinical Studies.

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

No publications provided by Stanford University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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: June 11, 2013
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on November 25, 2014