NCT03314051

Brief Summary

No previous study reported the treatment outcome of stage III nasopharyngeal carcinoma (NPC) patients. The investigators try to investigate the long-term treatment outcome of stage III NPC patients and do risk grouping by plasma Epstein-Barr virus (EBV) DNA assay for future therapy improvement.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
366

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2012

Longer than P75 for all trials

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

May 2, 2012

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
3.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2016

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

October 15, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 19, 2017

Completed
Last Updated

October 20, 2017

Status Verified

October 1, 2017

Enrollment Period

12 months

First QC Date

October 15, 2017

Last Update Submit

October 18, 2017

Conditions

Nasopharyngeal CarcinomaEBV Related Carcinoma

Keywords

Nasopharyngeal Carcinomaplasma EBV DNA

Outcome Measures

Primary Outcomes (1)

  • Overall survival (OS)

    Diagnosis to death

    5 year

Secondary Outcomes (3)

  • Progression-free survival (PFS)

    5 year

  • Distant metastasis failure-free survival (DMFFS)

    5 year

  • Locoregional failure-free survival (LRFFS)

    5 year

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Tissue proven stage III NPC patients and received curative treatment in our institute. Pre-treatment and post-radiotherapy plasma EBV DNA will be obtained.

You may qualify if:

  • Biopsy-proven stage III nasopharyngeal carcinoma (NPC)
  • Finished curative chemoradiotherapy
  • Have Pre-treatment and post-radiotherapy plasma EBV DNA

You may not qualify if:

  • No tissue proven NPC
  • Not finished curative treatment
  • No Pre-treatment and post- radiotherapy plasma EBV DNA

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Biospecimen

Retention: SAMPLES WITH DNA

We collected the pre-treatment and post-treatment plasma EBV DNA. The plasma EBV DNA assay was analyzed by real time PCR.

MeSH Terms

Conditions

Nasopharyngeal Carcinoma

Condition Hierarchy (Ancestors)

CarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsNasopharyngeal NeoplasmsPharyngeal NeoplasmsOtorhinolaryngologic NeoplasmsHead and Neck NeoplasmsNeoplasms by SiteNasopharyngeal DiseasesPharyngeal DiseasesStomatognathic DiseasesOtorhinolaryngologic Diseases

Study Officials

  • Jin-Ching Lin, MD.PhD.

    Department of Radiation Oncology, Taichung Veterans General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 15, 2017

First Posted

October 19, 2017

Study Start

May 2, 2012

Primary Completion

May 1, 2013

Study Completion

December 31, 2016

Last Updated

October 20, 2017

Record last verified: 2017-10