NCT03981224

Brief Summary

An additional blood test at 2-3 months after RT is a valuable biomarker in predicting treatment outcome for NPC patients. Patients with persistently detectable EBV DNA during re-staging survey 2-3 months after RT should strengthen adjuvant therapy due to very high subsequent relapse rate and poor survivals.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
706

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2012

Shorter than P25 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
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2013

Completed
6.1 years until next milestone

First Submitted

Initial submission to the registry

June 6, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 10, 2019

Completed
Last Updated

June 10, 2019

Status Verified

June 1, 2019

Enrollment Period

12 months

First QC Date

June 6, 2019

Last Update Submit

June 6, 2019

Conditions

Nasopharyngeal Carcinoma

Keywords

Nasopharyngeal carcinomaRadiotherapyEpstein-Barr virus

Outcome Measures

Primary Outcomes (1)

  • relapse-free survival (RFS)

    From the end of treatment to clinical or pathological proven disease relapse

    5 years

Secondary Outcomes (1)

  • Overall survival (OS)

    5 years

Other Outcomes (2)

  • locoregional failure-free survival (LRFFS)

    5 years

  • distant metastasis failure-free survival (DMFFS)

    5 years

Study Arms (2)

plasma EBV DNA detectable

the NPC patient received curative treatment and post-treatment plasma EBV DNA was detectable.

plasma EBV DNA undetectable

the NPC patient received curative treatment and post-treatment plasma EBV DNA was undetectable.

Eligibility Criteria

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

locally advanced NPC patients who finished curative RT with or without chemotherapy

You may qualify if:

  • histologically-proven nasopharyngeal carcinoma without distant metastasis (M0) at initial presentation
  • NPC patients who finished curative RT with or without chemotherapy

You may not qualify if:

  • initial present M1 disease
  • Secondary primary cancer diagnosed within 5 years
  • performance status (WHO scale) less than 2

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Biospecimen

Retention: SAMPLES WITH DNA

plasma EBV DNA concentrations

MeSH Terms

Conditions

Nasopharyngeal CarcinomaEpstein-Barr Virus Infections

Condition Hierarchy (Ancestors)

CarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsNasopharyngeal NeoplasmsPharyngeal NeoplasmsOtorhinolaryngologic NeoplasmsHead and Neck NeoplasmsNeoplasms by SiteNasopharyngeal DiseasesPharyngeal DiseasesStomatognathic DiseasesOtorhinolaryngologic DiseasesHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsTumor Virus Infections

Study Officials

  • Jin-Ching Lin, M.D.,PhD

    Taichung Veterans General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Jin-Ching Lin

Study Record Dates

First Submitted

June 6, 2019

First Posted

June 10, 2019

Study Start

May 2, 2012

Primary Completion

May 1, 2013

Study Completion

May 1, 2013

Last Updated

June 10, 2019

Record last verified: 2019-06