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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000029796
Receipt No. 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

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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
Email 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
Email nkjbm234@yahoo.co.jp

Sponsor
Institute Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, Department of Gastroenterology and Hepatology
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034047

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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