UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033189 |
|---|---|
| Receipt number | R000037808 |
| Scientific Title | Comparison of magnifying endoscopy with narrow band imaging (ME-NBI) attached balloon versus colposcopy for diagnosing cervical cancer, including acceptability of the endoscope: An exploratory prospective study |
| Date of disclosure of the study information | 2018/06/29 |
| Last modified on | 2020/11/18 16:59:17 |
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Basic information
Public title
Comparison of magnifying endoscopy with narrow band imaging (ME-NBI) attached balloon versus colposcopy for diagnosing cervical cancer, including acceptability of the endoscope: An exploratory prospective study
Acronym
Comparison of magnifying endoscopy with narrow band imaging (ME-NBI) attached balloon versus colposcopy for diagnosing cervical cancer, including acceptability of the endoscope: An exploratory prospective study
Scientific Title
Comparison of magnifying endoscopy with narrow band imaging (ME-NBI) attached balloon versus colposcopy for diagnosing cervical cancer, including acceptability of the endoscope: An exploratory prospective study
Scientific Title:Acronym
Comparison of magnifying endoscopy with narrow band imaging (ME-NBI) attached balloon versus colposcopy for diagnosing cervical cancer, including acceptability of the endoscope: An exploratory prospective study
Region
| Japan |
Condition
Condition
Cervical intraepithelial neoplasma, uteri cervical cancer
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Comparability of diagnostic accuracy of ME-NBI versus colposcopy, and comparison of patient's tolerability on each examination
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Sensitivity for detecting the highest lesion which is CIN2 or more
Key secondary outcomes
The visible rate of whole circumferential transition zone
The proportion of visible internal cervical canal
The complication rate
Comparison of patient's tolerability on each examination using questionnaire
The diagnostic accuracy of CIN at different stages (CIN1, CIN2, CIN3 or more)
Specificity, positive predictive value, and negative predictive value of CIN 2 or more detection
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
Prior to colposcopy, endoscopic examination using ME-NBI and 3% acetic acid dispersion is attempted for approximately ten minutes.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Female
Key inclusion criteria
Patients diagnosed as ASC-US, ASC-H, LSIL or HSIL by pap smear, or more than CIN3 by colposcopy are included.
Key exclusion criteria
Postoperative patients of cervical cancer, or patients with psychosis, or patients with pregnancy including suspicion are excluded.
Target sample size
95
Research contact person
Name of lead principal investigator
| 1st name | Kunihisa |
| Middle name | |
| Last name | Uchita |
Organization
Kochi Redcross Hospital
Division name
Gastroenterology
Zip code
780-8562
Address
Hadaminamimachi 1-4-63-11 Kochi city
TEL
088-822-1201
ucchy31@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Kunihisa |
| Middle name | |
| Last name | Uchita |
Organization
Kochi Redcross Hospital
Division name
Gastroenterology
Zip code
780-8562
Address
Hadaminamimachi 1-4-63-11 Kochi city
TEL
088-822-1201
Homepage URL
ucchy31@yahoo.co.jp
Sponsor or person
Institute
Kochi Redcross Hospital
Institute
Department
Personal name
Funding Source
Organization
Ministry of Educaction, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Kagawa University Hospital, Osaka International Cancer Institute
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kochi Redcross Hospital
Address
Hadaminamimachi 1-4-63-11 Kochi city
Tel
088-822-1201
ucchy31@yahoo.co.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 06 | Month | 29 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
88
Results
The detection sensitivity for patients with CIN2+ was not statistically different between the two methods (both: 79%, 95% CI: 66%-88%). For diagnosing CIN2+, ME-NBI tended to show a higher sensitivity than colposcopy (69% vs 58%, respectively), while its specificity tended to be lower vs. colposcopy (55% vs 70%, respectively). Patients reported significantly less discomfort and embarrassment with ME-NBI vs colposcopy.
Results date posted
| 2020 | Year | 11 | Month | 18 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The 88 consecutive patients (median age: 40.5 years, range: 21-67 years) comprised 72 with positive PAP smear test results, 13 with follow-up HSIL, and 3 with definitive CIN3 confirmed by a referral hospital. HPV infection history was positive in 25 patients, negative in 5, and undetermined in 58. A history of HPV vaccination was present in 5 patients and absent in 83. The final diagnoses comprised non-cancerous lesions (8), CIN1 (32), CIN2 (13), CIN3 (34), and microinvasive carcinoma (1).
Participant flow
Eligible patients had positive PAP smear test results, suspicious high-grade CIN in previous colposcopy, or definitive CIN3 diagnosed previously. A gastrointestinal endoscopist examined the cervix using ME-NBI in an endoscopy room and, subsequently, a gynecologist blinded to the ME-NBI findings performed colposcopy in a different room. CIN2+ locations were documented in a scheme immediately after each examination. Punch biopsy samples were obtained from all areas diagnosed as CIN2+ with both methods and from one normal area.
Adverse events
none
Outcome measures
The primary outcome was the detection sensitivity of patients with CIN2+, comparing ME-NBI and colposcopy.
The secondary outcome measures were the rates of visible whole circumferential transition zones, visible cervical orifice, and complications. Patient acceptance of both methods was compared by a questionnaire survey evaluating patients discomfort and embarrassment. Increasing degrees of discomfort and embarrassment were scored from 1-5. Patients were also asked which examination they would choose in future.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2018 | Year | 04 | Month | 26 | Day |
Date of IRB
| 2018 | Year | 04 | Month | 26 | Day |
Anticipated trial start date
| 2018 | Year | 04 | Month | 26 | Day |
Last follow-up date
| 2020 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
| 2020 | Year | 07 | Month | 31 | Day |
Date trial data considered complete
| 2020 | Year | 08 | Month | 31 | Day |
Date analysis concluded
| 2020 | Year | 09 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 06 | Month | 28 | Day |
Last modified on
| 2020 | Year | 11 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037808
