NCT03379610

Brief Summary

To evaluate the sensitivity and specificity of the combination of EBV and methylation marker genes in body fluids of both plasma and nasopharyngeal brush together for screening of early salvageable local residual and recurrent NPC that are missed by conventional clinical follow-up protocol.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
426

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2006

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

January 1, 2006

Completed
11.9 years until next milestone

First Submitted

Initial submission to the registry

December 10, 2017

Completed
10 days until next milestone

First Posted

Study publicly available on registry

December 20, 2017

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

April 30, 2021

Status Verified

April 1, 2021

Enrollment Period

12.9 years

First QC Date

December 10, 2017

Last Update Submit

April 28, 2021

Conditions

Nasopharyngeal Carcinoma

Outcome Measures

Primary Outcomes (1)

  • The sensitivity and specificity of the combination of EBV and methylation marker genes in body fluids of both plasma and nasopharyngeal brush

    12 years

Interventions

Nasopharngeal brushDIAGNOSTIC_TEST

1. Baseline nasopharngeal brush before treatment 2. Post-treatment reassessment of residual NPC

Also known as: Nasopharngeal swabs

Eligibility Criteria

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

Patients with nasopharngeeal carcinoma

You may qualify if:

  • diagnosed with nasopharngeal carcinoma
  • will receive radiotherapy after basline NP brush

You may not qualify if:

  • has received radiotherapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Biospecimen

Retention: SAMPLES WITH DNA

Nasopharyngeal brush NPC biopsy specimen Blood

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 Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

December 10, 2017

First Posted

December 20, 2017

Study Start

January 1, 2006

Primary Completion

December 1, 2018

Study Completion

December 1, 2018

Last Updated

April 30, 2021

Record last verified: 2021-04