Nasopharyngeal Carcinoma
Conditions
Keywords
Nasopharyngeal carcinoma, Narrow band imaging
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 1. To identify the vessel pattern of those confirmed NPC case using NBI system 2. To identify the endoscopy features of post-radiotherapy mucosal residual nasopharyngeal carcinoma using NBI system 3. To establish the positive predicted value, negative predicted value, sensitivity and specificity of using NBI system for detecting mucosal residual NPC Method: 1. All newly biopsy confirmed NPC patient will be assessed, their nasopharynx endoscopic image will be captured using both WL + NBI system 2. 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
Interventions
DEVICELaryngoscope with NBI system
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
Sponsors
Pamela Youde Nethersole Eastern Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Positive Nasopharynx Biopsy Results Detected by NBI System in Those Post-radiotherapy 8th Week NPC Patient | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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. |
| Assocication of Residual NPC With NBI Non Suspicious Pattern Group and NBI Suspicious Pattern Group | Post-radiotherapy eight weeks | 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. |
Countries
Hong Kong
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Post Radiotherapy 8 Weeks NPC Patient 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
Laryngoscope with NBI system: 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 | 55 |
| Total | 55 |
Baseline characteristics
| Characteristic | Post Radiotherapy 8 Weeks NPC Patient | — |
|---|---|---|
| Age, Customized < 18 years old | 0 Participants | — |
| Age, Customized >= 18 years old | 55 Participants | — |
| NPC patients | 40 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment Hong Kong | 55 participants | — |
| Sex: Female, Male Female | 8 Participants | — |
| Sex: Female, Male Male | 47 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 40 |
| other Total, other adverse events | 0 / 40 |
| serious Total, serious adverse events | 0 / 40 |
Outcome results
Primary
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
Time frame: Post-radiotherapy 8th week
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Post Radiotherapy 8 Weeks NPC Patient | Positive Nasopharynx Biopsy Results Detected by NBI System in Those Post-radiotherapy 8th Week NPC Patient | Grade A, no residual NPC | 14 participants |
| Post Radiotherapy 8 Weeks NPC Patient | Positive Nasopharynx Biopsy Results Detected by NBI System in Those Post-radiotherapy 8th Week NPC Patient | Grade A, positive residual NPC | 1 participants |
| Post Radiotherapy 8 Weeks NPC Patient | Positive Nasopharynx Biopsy Results Detected by NBI System in Those Post-radiotherapy 8th Week NPC Patient | Grade B, no residual NPC | 20 participants |
| Post Radiotherapy 8 Weeks NPC Patient | Positive Nasopharynx Biopsy Results Detected by NBI System in Those Post-radiotherapy 8th Week NPC Patient | Grade B, positive residual NPC | 1 participants |
| Post Radiotherapy 8 Weeks NPC Patient | Positive Nasopharynx Biopsy Results Detected by NBI System in Those Post-radiotherapy 8th Week NPC Patient | Grade C, no residual NPC | 1 participants |
| Post Radiotherapy 8 Weeks NPC Patient | Positive Nasopharynx Biopsy Results Detected by NBI System in Those Post-radiotherapy 8th Week NPC Patient | Grade C, positive residual NPC | 1 participants |
| Post Radiotherapy 8 Weeks NPC Patient | Positive Nasopharynx Biopsy Results Detected by NBI System in Those Post-radiotherapy 8th Week NPC Patient | Grade D, no residual NPC | 1 participants |
| Post Radiotherapy 8 Weeks NPC Patient | Positive Nasopharynx Biopsy Results Detected by NBI System in Those Post-radiotherapy 8th Week NPC Patient | Grade D, positive residual NPC | 1 participants |
Secondary
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.
Time frame: Post-radiotherapy eight weeks
Population: NBI non suspicious pattern = 36 NBI suspcious pattern = 4 Total = 40
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Post Radiotherapy 8 Weeks NPC Patient | Assocication of Residual NPC With NBI Non Suspicious Pattern Group and NBI Suspicious Pattern Group | NBI non suspicious pattern | without residual disease | 34 Participants |
| Post Radiotherapy 8 Weeks NPC Patient | Assocication of Residual NPC With NBI Non Suspicious Pattern Group and NBI Suspicious Pattern Group | NBI non suspicious pattern | with residual disease | 2 Participants |
| Post Radiotherapy 8 Weeks NPC Patient | Assocication of Residual NPC With NBI Non Suspicious Pattern Group and NBI Suspicious Pattern Group | NBI suspicious pattern | without residual disease | 2 Participants |
| Post Radiotherapy 8 Weeks NPC Patient | Assocication of Residual NPC With NBI Non Suspicious Pattern Group and NBI Suspicious Pattern Group | NBI suspicious pattern | with residual disease | 2 Participants |
Comparison: 2x2 table of: Row: 1. NBI suspicious pattern 2. NBI non-suspicious pattern Category: 1. with residual disease 2. without residual diseasep-value: 0.004Chi-squared
Secondary
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.
Time frame: Post-radiotherapy eight weeks
Population: NBI non suspicious pattern = 36 NBI suspcious pattern = 4 Total = 40
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Post Radiotherapy 8 Weeks NPC Patient | The Sensitivity, Specificity, Positive Predicted Valve and Negative Predicted Valve of Detecting Mucosal Residual NPC Using NBI Suspicious/ Non Suspicous Pattern | Sensitivity | 50 Percentage of participants |
| Post Radiotherapy 8 Weeks NPC Patient | The Sensitivity, Specificity, Positive Predicted Valve and Negative Predicted Valve of Detecting Mucosal Residual NPC Using NBI Suspicious/ Non Suspicous Pattern | Positive Predicted Valve | 50 Percentage of participants |
| Post Radiotherapy 8 Weeks NPC Patient | The Sensitivity, Specificity, Positive Predicted Valve and Negative Predicted Valve of Detecting Mucosal Residual NPC Using NBI Suspicious/ Non Suspicous Pattern | Specificity | 94 Percentage of participants |
| Post Radiotherapy 8 Weeks NPC Patient | The Sensitivity, Specificity, Positive Predicted Valve and Negative Predicted Valve of Detecting Mucosal Residual NPC Using NBI Suspicious/ Non Suspicous Pattern | Negative Predicted Valve | 94 Percentage of participants |