NCT02584790

Brief Summary

NBI has been proven to be a useful tool to detect early NPC, but they were few studies concerning the detection of post-radiotherapy mucosal residual NPC using NBI system

Trial Health

87
On Track

Trial Health Score

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

Enrollment
55

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2015

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

First Submitted

Initial submission to the registry

August 17, 2015

Completed
2 months until next milestone

First Posted

Study publicly available on registry

October 23, 2015

Completed
9 days until next milestone

Study Start

First participant enrolled

November 1, 2015

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2017

Completed
7 months until next milestone

Results Posted

Study results publicly available

October 20, 2017

Completed
Last Updated

December 8, 2017

Status Verified

October 1, 2017

Enrollment Period

1.4 years

First QC Date

August 17, 2015

Results QC Date

April 19, 2017

Last Update Submit

October 21, 2017

Conditions

Nasopharyngeal Carcinoma

Keywords

Nasopharyngeal carcinomaNarrow band imaging

Outcome Measures

Primary Outcomes (1)

  • Positive Nasopharynx Biopsy Results Detected by NBI System in Those Post-radiotherapy 8th Week NPC Patient

    4 grading of NBI vessel patterns can be identified in those post-radiotherapy 8 weeks NPC patients. Grade A: normal vessel size and length, regular pattern Grade B: normal vessel size, short, regular spiderweb like pattern Grade C: irregular vessel size and length, distorted and irregular pattern Grade D: thickened vessel size, elongated, distorted, and earthworm pattern

    Post-radiotherapy 8th week

Secondary Outcomes (2)

  • Assocication of Residual NPC With NBI Non Suspicious Pattern Group and NBI Suspicious Pattern Group

    Post-radiotherapy eight weeks

  • The Sensitivity, Specificity, Positive Predicted Valve and Negative Predicted Valve of Detecting Mucosal Residual NPC Using NBI Suspicious/ Non Suspicous Pattern

    Post-radiotherapy eight weeks

Study Arms (1)

Post radiotherapy 8 weeks NPC patient

OTHER

All post-radiotherapy 8 weeks NPC patient will routinely undergo laryngoscope examination (WL system) and NP biopsy will be taken at the same time to determine if there is any residual NPC. In this study, laryngoscope with NBI system will be used. NBI system will be turn on during the post radiotherapy 8 week laryngoscope examination in additional to routine WL system

Device: Laryngoscope with NBI system

Interventions

Laryngoscope with NBI systemDEVICE

All post-radiotherapy 8 weeks NPC patient will routinely undergo laryngoscope examination (WL system) and NP biopsy will be taken at the same time to determine if there is any residual NPC. In this study, laryngoscope with NBI system will be used. NBI system will be turn on during the post radiotherapy 8 week laryngoscope examination in additional to routine WL system

Post radiotherapy 8 weeks NPC patient

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • all new NPC patient

You may not qualify if:

  • History of radiotherapy to head and neck region
  • Poor premorbid status/ non-communicable patients
  • \<18 years old
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pamela Youde Nethersole Eastern Hospital

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Nasopharyngeal Carcinoma

Interventions

Laryngoscopes

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

EndoscopesDiagnostic EquipmentEquipment and SuppliesSurgical Equipment

Limitations and Caveats

Small sample size Observation bias Musosal trauma during endoscopy examination hinder vessel identification

Results Point of Contact

Title
Dr Wong Kai Chuen
Organization
Pamela Youde Nethersole Eastern Hospital
wkc568@ha.org.hk
(852) 64600771

Study Officials

  • Wong Kai Chuen, MBChB, MRCS

    Pamela Youde Nethersole Eastern Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

August 17, 2015

First Posted

October 23, 2015

Study Start

November 1, 2015

Primary Completion

April 1, 2017

Study Completion

April 1, 2017

Last Updated

December 8, 2017

Results First Posted

October 20, 2017

Record last verified: 2017-10

Locations

HK(1)