UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051910 |
|---|---|
| Receipt number | R000058809 |
| Scientific Title | Usability of an ultra-thin endoscopy for diagnosing superficial squamous neoplasms in the pharynx and esophagus : a prospective randomized clinical trial |
| Date of disclosure of the study information | 2023/08/15 |
| Last modified on | 2023/08/15 13:03:17 |
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Basic information
Public title
Usability of an ultra-thin endoscopy for diagnosing pharyngeal and esophageal cancer
Acronym
Diagnosis of pharyngeal and esophageal cancer using an ultra-thin endoscopy
Scientific Title
Usability of an ultra-thin endoscopy for diagnosing superficial squamous neoplasms in the pharynx and esophagus : a prospective randomized clinical trial
Scientific Title:Acronym
Diagnosis of superficial squamous neoplasms in the pharynx and esophagus using an ultra-thin endoscope
Region
| Japan |
Condition
Condition
superficial squamous neoplasms in the pharynx and esophagus
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Usability of an ultra-thin endoscopy for diagnosing pharyngeal and esophageal cancer
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
A sensitivity of superficial pharyngeal or esophageal cancer using an ultra-thin endoscopy and magnified endoscopy
Key secondary outcomes
1. Diagnostic performance of an ultra-thin endoscopy and magnified endoscopy for superficial pharyngeal or esophageal cancer
2. Characteristics of undetectable superficial pharyngeal or esophageal cancer using ultra-thin endoscopy
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
An ultra-thin endoscopy will be used for the first examination
Interventions/Control_2
A magnified endoscopy will be used for the first examination
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. The patients with present or past history of superficial pharyngeal or esophageal neoplasia
2. The patients who agree with the informed consent
Key exclusion criteria
1. A Patient aged < 20
2. The patients who have history of chemotherapy in a year
3. The patients whose biopsy is prohibited
4. The patients who have allergy for Lugol
5.The patients who are evaluated inappropriate for the research
Target sample size
226
Research contact person
Name of lead principal investigator
| 1st name | Akira |
| Middle name | |
| Last name | Dobashi |
Organization
The Jikei University School of Medicine
Division name
Department of Endoscopy
Zip code
1058461
Address
3-25-8 Nishishimbashi, Minatoku, Tokyo
TEL
03-3433-1111
ad99061@jikei.ac.jp
Public contact
Name of contact person
| 1st name | Akira |
| Middle name | |
| Last name | Dobashi |
Organization
The Jikei University School of Medicine
Division name
Department of Endoscopy
Zip code
1058461
Address
3-25-8 Nishishimbashi, Mnatoku, Tokyo
TEL
0334331111
Homepage URL
ad99061@jikei.ac.jp
Sponsor or person
Institute
The Jikei University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Research fund of The Jikei University School of Medicine, Department of Endoscopy
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Jikei University School of Medicine
Address
3-25-8 Nishi-shimbashi, Minato-ku, Tokyo
Tel
03-3433-1111
rinri@jikei.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
35-048(11671)
Org. issuing International ID_1
The Jikei University School of Medicine
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 08 | Month | 15 | 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
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2023 | Year | 06 | Month | 09 | Day |
Date of IRB
| 2023 | Year | 06 | Month | 16 | Day |
Anticipated trial start date
| 2023 | Year | 08 | Month | 15 | Day |
Last follow-up date
| 2026 | 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
| 2023 | Year | 08 | Month | 15 | Day |
Last modified on
| 2023 | Year | 08 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058809
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
