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

Sponsor
Stanford University (Other)
Overall Status
Completed
CT.gov ID
NCT00186433
Collaborator
(none)
49
Enrollment
1
Location
139
Duration (Months)
0.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

  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 or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    49 participants
    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
    Study Start Date :
    Nov 1, 2001
    Actual Primary Completion Date :
    Jun 1, 2013
    Actual Study Completion Date :
    Jun 1, 2013

    Outcome Measures

    Primary Outcome Measures

    1. Plasma Epstein-Bar Virus (EBV) DNA concentrations [every 6 months until end of study]

      measured by quantitative polymerase chain reaction (PCR)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 Stanford University School of Medicine Stanford California United States 94305

    Sponsors and Collaborators

    • Stanford University

    Investigators

    • Principal Investigator: Quynh-Thu Le, Stanford University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Quynh-Thu Le, Katharine Dexter McCormick and Stanley McCormick Memorial Professor, Stanford University
    ClinicalTrials.gov Identifier:
    NCT00186433
    Other Study ID Numbers:
    • ENT0006
    • ENT0006
    • 77622
    First Posted:
    Sep 16, 2005
    Last Update Posted:
    May 27, 2015
    Last Verified:
    May 1, 2015
    Additional relevant MeSH terms:
    Nasopharyngeal Carcinoma
    Mouth Neoplasms
    Lip Neoplasms

    Study Results

    No Results Posted as of May 27, 2015