Nasopharyngeal CarcinomaNCT02584790
NBI to Detect Post-RT Mucosal Residual NPC
A study testing Laryngoscope with NBI system in people with Nasopharyngeal Carcinoma, run by Pamela Youde Nethersole Eastern Hospital at 1 site in Hong Kong.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nasopharyngeal Carcinoma
- What is being tested?
- Laryngoscope with NBI system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteHong Kong
- Study dates
- Nov 2015to Apr 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- all new NPC patient
Who cannot join
- History of radiotherapy to head and neck region
- Poor premorbid status/ non-communicable patients
- <18 years old
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Using Narrow-band Imaging (NBI) Technique to Detect Post-radiotherapy Mucosal Residual Nasopharyngeal Carcinoma (NPC)
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
Read the 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
- Conditions
- Nasopharyngeal Carcinoma
- Being tested
- Laryngoscope with NBI system
- Keywords
- Nasopharyngeal carcinoma, Narrow band imaging
- Medical subject headings
- Nasopharyngeal Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: Laryngoscope with NBI system |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Post-radiotherapy 8th week
Secondary outcomes (2)
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.
Measured: 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
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.
Measured: Post-radiotherapy eight weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2015 (estimated)
- Study startNov 2015
- Primary completionApr 2017
- Study completionApr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Nasopharyngeal CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pamela Youde Nethersole Eastern Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Wong Kai Chuen, Pamela Youde Nethersole Eastern Hospital
- Investigators
- Wong Kai Chuen, MBChB, MRCS, Principal investigator, Pamela Youde Nethersole Eastern Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02584790
- Sponsor's protocol ID
- NBI1782015
- Status last verified
- Oct 2017
- First submitted
- 17 Aug 2015
- Last updated
- 8 Dec 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Narrow-band Imaging (NBI) Technique to Detect Post-radiotherapy Mucosal Residual Nasopharyngeal Carcinoma (NPC)
- ClinicalTrials.gov ID
- NCT02584790
- Acronym / sponsor ID
- NBI1782015
- Conditions
- Nasopharyngeal Carcinoma
- Keywords
- Nasopharyngeal carcinoma, Narrow band imaging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Pamela Youde Nethersole Eastern HospitalUniversity, hospital or other
- Study start
- Nov 2015
- Primary completion
- Apr 2017 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 23 Oct 2015 (estimated)
- Results
- Posted 20 Oct 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Post radiotherapy 8 weeks NPC patient | Other | Device: Laryngoscope with NBI systemAll 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- all new NPC patient
Key exclusion criteria (4 listed)
- History of radiotherapy to head and neck region
- Poor premorbid status/ non-communicable patients
- <18 years old
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laryngoscope with NBI systemAll 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 | Post radiotherapy 8 weeks NPC patient |
Primary outcome
Positive Nasopharynx Biopsy Results Detected by NBI System in Those Post-radiotherapy 8th Week NPC Patient
Time frame: Post-radiotherapy 8th week
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
2 secondary outcomes
Assocication of Residual NPC With NBI Non Suspicious Pattern Group and NBI Suspicious Pattern Group
Time frame: 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
Time frame: Post-radiotherapy eight weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wong Kai Chuen, MBChB, MRCS principal investigator
Pamela Youde Nethersole Eastern Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laryngoscope with NBI system in people with Nasopharyngeal Carcinoma, run by Pamela Youde Nethersole Eastern Hospital at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Oct 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Positive Nasopharynx Biopsy Results Detected by NBI System in Those Post-radiotherapy 8th Week NPC Patient (time frame: Post-radiotherapy 8th week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2017.