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NBI to Detect Post-RT Mucosal Residual NPC

Primary Purpose

Nasopharyngeal Carcinoma

Status
Completed
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Laryngoscope with NBI system
Sponsored by
Pamela Youde Nethersole Eastern Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Nasopharyngeal Carcinoma focused on measuring Nasopharyngeal carcinoma, Narrow band imaging

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • all new NPC patient

Exclusion Criteria:

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

Sites / Locations

  • Pamela Youde Nethersole Eastern Hospital

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Post radiotherapy 8 weeks NPC patient

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Assocication of Residual NPC With NBI Non Suspicious Pattern Group and NBI Suspicious Pattern Group
Non suspicious pattern = grade A + grade B Suspicious pattern = grade C + D The sensitivity, specificity, positive predicted valve and negative predicted valve of detecting mucosal residual NPC using NBI suspicious/ non suspicous pattern can be thus calculated.
The Sensitivity, Specificity, Positive Predicted Valve and Negative Predicted Valve of Detecting Mucosal Residual NPC Using NBI Suspicious/ Non Suspicous Pattern
Non suspicious pattern = grade A + grade B Suspicious pattern = grade C + D The sensitivity, specificity, positive predicted valve and negative predicted valve of detecting mucosal residual NPC using NBI suspicious/ non suspicous pattern can be thus calculated.

Full Information

First Posted
August 17, 2015
Last Updated
October 21, 2017
Sponsor
Pamela Youde Nethersole Eastern Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02584790
Brief Title
NBI to Detect Post-RT Mucosal Residual NPC
Official Title
Using Narrow-band Imaging (NBI) Technique to Detect Post-radiotherapy Mucosal Residual Nasopharyngeal Carcinoma (NPC)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
November 2015 (undefined)
Primary Completion Date
April 2017 (Actual)
Study Completion Date
April 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Pamela Youde Nethersole Eastern Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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
Detailed Description
Background NPC has a uniquely high prevalence in Southern China. According to the Hong Kong Cancer Registry in 2012, NPC was the sixth commonest cancer in men and thirteenth in women. It accounted for 2.9% of all new cancer cases. In 2012, there were 819 new cases of NPC. NPC is highly radiosensitive. Radiotherapy and chemotherapy are the mainstay of treatment. Despite the chemo-irradiation, disease control failure still occurred in NPC patients presenting as persistent tumor. Early detection of those post-radiotherapy residual NPC is essential for early arrangement of salvage therapy. Detection methods include imaging, plasma Epstein-Barr virus DNA, endoscopy examinations and nasopharynx biopsy. NBI system has been well proven as a tool to detect early digestive tract cancer and head and neck cancer. However, there were only few studies targeting the detection of post-radiotherapy mucosal residual of NPC using NBI system Objective To identify the vessel pattern of those confirmed NPC case using NBI system To identify the endoscopy features of post-radiotherapy mucosal residual nasopharyngeal carcinoma using NBI system To establish the positive predicted value, negative predicted value, sensitivity and specificity of using NBI system for detecting mucosal residual NPC Method: All newly biopsy confirmed NPC patient will be assessed, their nasopharynx endoscopic image will be captured using both WL + NBI system At post-radiotherapy 8th weeks, endoscopic examination will be arranged for patient using both WL + NBI system, biopsy will also be taken to detect mucosal residual NPC

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nasopharyngeal Carcinoma
Keywords
Nasopharyngeal carcinoma, Narrow band imaging

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
55 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Post radiotherapy 8 weeks NPC patient
Arm Type
Other
Arm Description
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
Intervention Type
Device
Intervention Name(s)
Laryngoscope with NBI system
Intervention Description
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
Primary Outcome Measure Information:
Title
Positive Nasopharynx Biopsy Results Detected by NBI System in Those Post-radiotherapy 8th Week NPC Patient
Description
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
Time Frame
Post-radiotherapy 8th week
Secondary Outcome Measure Information:
Title
Assocication of Residual NPC With NBI Non Suspicious Pattern Group and NBI Suspicious Pattern Group
Description
Non suspicious pattern = grade A + grade B Suspicious pattern = grade C + D The sensitivity, specificity, positive predicted valve and negative predicted valve of detecting mucosal residual NPC using NBI suspicious/ non suspicous pattern can be thus calculated.
Time Frame
Post-radiotherapy eight weeks
Title
The Sensitivity, Specificity, Positive Predicted Valve and Negative Predicted Valve of Detecting Mucosal Residual NPC Using NBI Suspicious/ Non Suspicous Pattern
Description
Non suspicious pattern = grade A + grade B Suspicious pattern = grade C + D The sensitivity, specificity, positive predicted valve and negative predicted valve of detecting mucosal residual NPC using NBI suspicious/ non suspicous pattern can be thus calculated.
Time Frame
Post-radiotherapy eight weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: all new NPC patient Exclusion Criteria: History of radiotherapy to head and neck region Poor premorbid status/ non-communicable patients <18 years old Pregnancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wong Kai Chuen, MBChB, MRCS
Organizational Affiliation
Pamela Youde Nethersole Eastern Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pamela Youde Nethersole Eastern Hospital
City
Hong Kong
Country
Hong Kong

12. IPD Sharing Statement

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NBI to Detect Post-RT Mucosal Residual NPC

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