NCT00186433

Brief Summary

  1. 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. 2.To relate pretreatment plasma EBV DNA concentration to WHO classification of these tumors both in endemic and non-endemic areas.
  3. 3.To determine whether pretreatment plasma EBV DNA can serve as a prognostic factor for both endemic and non-endemic patient populations.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
49

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2001

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2001

Completed
3.9 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 16, 2005

Completed
7.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
Last Updated

May 27, 2015

Status Verified

May 1, 2015

Enrollment Period

11.6 years

First QC Date

September 13, 2005

Last Update Submit

May 22, 2015

Conditions

Mouth CancerLip CancerThroat CancerLip NeoplasmsHead and Neck Cancers

Outcome Measures

Primary Outcomes (1)

  • Plasma Epstein-Bar Virus (EBV) DNA concentrations

    measured by quantitative polymerase chain reaction (PCR)

    every 6 months until end of study

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Having a new diagnosis of Nasopharyngeal carcinoma

You may qualify if:

  • Having a new diagnosis of Nasopharyngeal carcinoma.
  • Being treated with either radiotherapy or chemoradiotherapy for this condition.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

Related Publications (1)

  • 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.

    PMID: 23459720DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

blood

MeSH Terms

Conditions

Mouth NeoplasmsLip NeoplasmsHead and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsMouth DiseasesStomatognathic DiseasesLip Diseases

Study Officials

  • Quynh-Thu Le

    Stanford University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Katharine Dexter McCormick and Stanley McCormick Memorial Professor

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 16, 2005

Study Start

November 1, 2001

Primary Completion

June 1, 2013

Study Completion

June 1, 2013

Last Updated

May 27, 2015

Record last verified: 2015-05

Locations

US(1)