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

September 13, 2005
June 11, 2013
November 2001
June 2013   (final data collection date for primary outcome measure)
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)
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Complete list of historical versions of study NCT00186433 on ClinicalTrials.gov Archive Site
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A Longitudinal Study of Plasma EBV DNA in Nasopharyngeal Carcinoma From Both Endemic and Non-Endemic Patient Populations
A Longitudinal Study of Plasma EBV DNA in Nasopharyngeal Carcinoma From Both Endemic and Non-Endemic Patient Populations
  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.
Not Provided
Observational
Observational Model: Case Control
Time Perspective: Prospective
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Retention:   Samples With DNA
Description:

blood

Non-Probability Sample

Having a new diagnosis of Nasopharyngeal carcinoma

  • Mouth Cancer
  • Lip Cancer
  • Throat Cancer
  • Lip Neoplasms
  • Head and Neck Cancers
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Le QT, Zhang Q, Cao H, Cheng AJ, Pinsky BA, Hong RL, Chang JT, Wang CW, Tsao KC, Lo YD, Lee N, Ang KK, Chan AT, Chan KC. An international collaboration to harmonize the quantitative plasma Epstein-Barr virus DNA assay for future biomarker-guided trials in nasopharyngeal carcinoma. Clin Cancer Res. 2013 Apr 15;19(8):2208-15. doi: 10.1158/1078-0432.CCR-12-3702. Epub 2013 Mar 4.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
150
June 2013
June 2013   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00186433
ENT0006, ENT0006, 77622
Yes
Stanford University
Stanford University
Not Provided
Principal Investigator: Quynh-Thu Le Stanford University
Stanford University
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP