UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032151 |
|---|---|
| Receipt number | R000034149 |
| Scientific Title | A multicenter phase II trial of the applicability and safety of magnifying narrow-band imaging for diagnosis of histological type of early gastric cancer |
| Date of disclosure of the study information | 2018/04/08 |
| Last modified on | 2020/09/21 10:50:50 |
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Basic information
Public title
A multicenter phase II trial of the applicability and safety of magnifying narrow-band imaging for diagnosis of histological type of early gastric cancer
Acronym
A multicenter phase II trial of the applicability and safety of M-NBI for diagnosis of histological type of early gastric cancer
Scientific Title
A multicenter phase II trial of the applicability and safety of magnifying narrow-band imaging for diagnosis of histological type of early gastric cancer
Scientific Title:Acronym
A multicenter phase II trial of the applicability and safety of M-NBI for diagnosis of histological type of early gastric cancer
Region
| Japan |
Condition
Condition
Gastric cancer
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to confirm the applicability and safety of adding magnifying narrow-band imaging (M-NBI) to white-light endoscopy in the diagnosis of histological type of early gastric cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary endpoint is diagnostic accuracy to distinguish undifferentiated- from differentiated-type early gastric cancer.
Key secondary outcomes
The key secondary endpoint is specificity to distinguish undifferentiated- from differentiated-type early gastric cancer.
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
| Maneuver |
Interventions/Control_1
Forceps biopsy
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Histologically proven cT1 gastric cancer.
2. Planned to undergo endoscopic resection or gastrectomy in the participant institutions.
3. Aged more than 20 years.
Key exclusion criteria
1. Risk of bleeding after biopsy.
2. History of gastrectomy.
3. Macroscopically, the targeted lesion is elevated type.
4. The size of the targeted lesion is smaller than 5 mm.
5. Erosion or an ulcer in the center of the targeted lesion.
6. Informed consent was not obtained.
Target sample size
207
Research contact person
Name of lead principal investigator
| 1st name | Kenshi |
| Middle name | |
| Last name | Yao |
Organization
Fukuoka University Chikushi Hospital
Division name
Department of Endoscopy
Zip code
541-8567
Address
1-1-1 Zokumyoin, Chikushino City, Fukuoka 818-8502, Japan
TEL
092-921-1011
yao@fukuoka-u.ac.jp
Public contact
Name of contact person
| 1st name | Takashi |
| Middle name | |
| Last name | Kanesaka |
Organization
Osaka International Cancer Institute
Division name
Department of Gastrointestinal Oncology
Zip code
541-8567
Address
3-1-69, Otemae, Chuo-ku, Osaka 541-8567, Japan
TEL
06-6945-1181
Homepage URL
takashikanesaka@gmail.com
Sponsor or person
Institute
Osaka International Cancer Institute
Institute
Department
Personal name
Funding Source
Organization
The Yasuda Medical Foundation
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee of Osaka International Cancer Institute
Address
3-1-69, Otemae, Chuo-ku, Osaka 541-8567, Japan
Tel
06-6945-1181
rinri01@opho.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 | 04 | Month | 08 | 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
208
Results
In WLE, the accuracy, sensitivity, and specificity for
undifferentiated-type cancer were 80%, 69%, and 84%,
respectively. In M-NBI, the accuracy, sensitivity, and
specificity for undifferentiated-type cancer were 82%,
53%, and 93%, respectively.
Results date posted
| 2020 | Year | 09 | Month | 21 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Between September 2018 and September 2019, 208
patients were enrolled from six tertiary care institutions in
Japan. Informed consent of five patients had not been
stored, and one patient withdrew participation in this trial
after enrollment. Among 202 patients who underwent
protocol endoscopy, the procedure was completed in 192
patients by 41 endoscopists. Histological examinations of
the biopsy specimen revealed that 25 lesions were not
cancer. Finally, 167 cancerous lesions were included in the
main analysis.
Adverse events
No adverse event occurred during and after protocol
endoscopy in 203 patients.
Outcome measures
There was no significant difference in accuracy between
WLE and M-NBI (p = 0.755), but specificity was
significantly higher with M-NBI than with WLE (p = 0.041).
When the lesion showed a paler color and
undifferentiated-type pattern on M-NBI, the accuracy,
sensitivity, specificity, and positive likelihood ratio for
undifferentiated-type cancer were 81%, 38%, 97%, and
11.5, respectively.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 12 | Month | 25 | Day |
Date of IRB
| 2017 | Year | 12 | Month | 22 | Day |
Anticipated trial start date
| 2018 | Year | 04 | Month | 09 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 04 | Month | 08 | Day |
Last modified on
| 2020 | Year | 09 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034149
| Research Plan | |
|---|---|
| Registered date | File name |
| 2020/09/19 | Research plan_final.pdf |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
| 2020/09/21 | Data_UMIN000032151.xlsx |
