UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058239 |
|---|---|
| Receipt number | R000066578 |
| Scientific Title | A Non-Inferiority Study of 0.8% Lugol's Iodine Staining versus 1.5% for the Detection of Esophageal Epithelial Neoplasia |
| Date of disclosure of the study information | 2025/07/01 |
| Last modified on | 2025/06/20 15:22:09 |
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Basic information
Public title
A Non-Inferiority Study of 0.8% Lugol's Iodine Staining versus 1.5% for the Detection of Esophageal Epithelial Neoplasia
Acronym
A Non-Inferiority Study of 0.8% Lugol's Iodine Staining versus 1.5% for the Detection of Esophageal Epithelial Neoplasia
Scientific Title
A Non-Inferiority Study of 0.8% Lugol's Iodine Staining versus 1.5% for the Detection of Esophageal Epithelial Neoplasia
Scientific Title:Acronym
A Non-Inferiority Study of 0.8% Lugol's Iodine Staining versus 1.5% for the Detection of Esophageal Epithelial Neoplasia
Region
| Japan |
Condition
Condition
Esophageal Squamous Cell Carcinoma
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the non-inferiority of 0.8% iodine staining compared to 1.5% iodine staining in the diagnostic performance for superficial esophageal squamous cell carcinoma.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Diagnostic accuracy of 0.8% iodine staining compared to 1.5% iodine staining for superficial esophageal squamous cell carcinoma
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Dose comparison
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Intervention
No. of arms
2
Purpose of intervention
Diagnosis
Type of intervention
| Medicine |
Interventions/Control_1
During esophagogastroduodenoscopy for esophageal cancer screening and surveillance, participants will undergo iodine staining with 1.5% iodine solution.
Interventions/Control_2
During esophagogastroduodenoscopy for esophageal cancer screening and surveillance, participants will undergo iodine staining with 0.8% iodine solution.
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
| 89 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Individuals who are predicted in advance to require iodine staining during esophagogastroduodenoscopy for esophageal cancer screening or surveillance, based on being at high risk for esophageal cancer
Individuals who have received a full explanation of the study, fully understood its contents, and voluntarily agreed to participate by providing written informed consent
Key exclusion criteria
Individuals with an allergy to iodine
Individuals diagnosed with advanced esophageal cancer (those with a history of esophageal cancer may be included if the cancer has been cured)
Individuals with esophageal cancer of a histological type other than squamous cell carcinoma
Individuals who are unable to undergo biopsy
Individuals who have undergone iodine staining within the past month
Individuals who have undergone surgery involving the esophagus
Individuals who are deemed unsuitable for participation in the study by the principal investigator for any other reason
Target sample size
353
Research contact person
Name of lead principal investigator
| 1st name | Shoko |
| Middle name | |
| Last name | Ono |
Organization
Hokkaido University Hospital
Division name
Division of Endoscopy
Zip code
060-8648
Address
Kita 14-jo Nishi 5-chome, Kita-ku, Sapporo, Hokkaido, Japan
TEL
011-716-1161
onosho@med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | Masaki |
| Middle name | |
| Last name | Inoue |
Organization
Hokkaido University Hospital
Division name
Division of Endoscopy
Zip code
060-8648
Address
Kita 14-jo Nishi 5-chome, Kita-ku, Sapporo, Hokkaido, Japan
TEL
011-716-1161
Homepage URL
mokomokomomon@gmail.com
Sponsor or person
Institute
Hokkaido University
Institute
Department
Personal name
Funding Source
Organization
Self-funded
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
Ethical Review Board for Life Science and Medical Research, Hokkaido University Hospital
Address
Kita 14-jo Nishi 5-chome, Kita-ku, Sapporo, Hokkaido, Japan
Tel
011-706-7636
crjimu@huhp.hokudai.ac.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
| 2025 | Year | 07 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 06 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2029 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 06 | Month | 20 | Day |
Last modified on
| 2025 | Year | 06 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066578
