UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029796 |
|---|---|
| Receipt number | R000034047 |
| Scientific Title | Randomized, double-blind study to evaluate the sensitivity and painfulness of different concentration of iodine solution during endoscopic examination to detect esophageal squamous epithelial tumor. |
| Date of disclosure of the study information | 2017/12/16 |
| Last modified on | 2019/05/07 19:16:25 |
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Basic information
Public title
Randomized, double-blind study to evaluate the sensitivity and painfulness of different concentration of iodine solution during endoscopic examination to detect esophageal squamous epithelial tumor.
Acronym
Randomized, double-blind study to evaluate the sensitivity and painfulness of different concentration of iodine solution during endoscopic examination to detect esophageal squamous epithelial tumor.
Scientific Title
Randomized, double-blind study to evaluate the sensitivity and painfulness of different concentration of iodine solution during endoscopic examination to detect esophageal squamous epithelial tumor.
Scientific Title:Acronym
Randomized, double-blind study to evaluate the sensitivity and painfulness of different concentration of iodine solution during endoscopic examination to detect esophageal squamous epithelial tumor.
Region
| Japan |
Condition
Condition
esophageal squamous epithelial tumor
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
to evaluate the sensitivity and painfulness of different concentration of iodine solution during endoscopic examination to detect esophageal squamous epithelial tumor.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
painfulness of different concentration of iodine solution
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
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Diagnosis
Type of intervention
| Medicine |
Interventions/Control_1
different concentration of iodine solution(1%)
Interventions/Control_2
different concentration of iodine solution(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
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1)The patients who have a superficial esophageal squamous cell carcinoma
2)A patient undergoing endoscopic examination after ESD for superficial esophageal cancer.
3)A past history of head and neck squamous cell cancer.
4)A patient who has more than six points in HRA-F score for esophageal cancer
5)A patient aged 20 years or older at the time of enrollment.
6)A patient who has provided written informed consent to participate in this study.
Key exclusion criteria
1) The patients treated by chemotherapy or radiotherapy and surgery for esophageal SCC or head and neck cancer.
2) A history of iodine hypersensitivity
3) A patient with sedative drugs
4) Pregnant or breast-feeding woman
5) A patient who has not provided written informed consent to participate in this study.
6) In certain circumstances that the researchers determined it was not suitable for the research
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Okada |
Organization
Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Division name
Department of Gastroenterology and Hepatology
Zip code
700-8558
Address
2-5-1 Shikata, Okayama 700-8558, Japan
TEL
086-235-7218
hiro@md.okayama-u.ac.jp
Public contact
Name of contact person
| 1st name | Tatsuhiro |
| Middle name | |
| Last name | Gotoda |
Organization
Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Division name
Department of Gastroenterology and Hepatology
Zip code
700-8558
Address
2-5-1 Shikata, Okayama 700-8558, Japan
TEL
086-235-7218
Homepage URL
nkjbm234@yahoo.co.jp
Sponsor or person
Institute
Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, Department of Gastroenterology and Hepatology
Institute
Department
Personal name
Funding Source
Organization
Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, Department of Gastroenterology and Hepatology
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
Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, Department of Gastroenterology and Hepatology
Address
2-5-1 Shikata, Okayama 700-8558, Japan
Tel
086-235-7218
nkjbm234@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
| 2017 | Year | 12 | Month | 16 | 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
Completed
Date of protocol fixation
| 2017 | Year | 10 | Month | 30 | Day |
Date of IRB
| 2018 | Year | 02 | Month | 20 | Day |
Anticipated trial start date
| 2017 | Year | 12 | Month | 16 | Day |
Last follow-up date
| 2019 | 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
| 2017 | Year | 11 | Month | 01 | Day |
Last modified on
| 2019 | Year | 05 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034047
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