UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027696 |
|---|---|
| Receipt number | R000031725 |
| Scientific Title | Dose finding study for deciding the optimal dose of fluorescein during probe based confocal endomicroscopy |
| Date of disclosure of the study information | 2017/06/12 |
| Last modified on | 2017/06/08 21:19:57 |
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Basic information
Public title
Dose finding study for deciding the optimal dose of fluorescein during probe based confocal endomicroscopy
Acronym
Dose finding study of fluorescein for pCLE
Scientific Title
Dose finding study for deciding the optimal dose of fluorescein during probe based confocal endomicroscopy
Scientific Title:Acronym
Dose finding study of fluorescein for pCLE
Region
| Japan |
Condition
Condition
gastrointestinal cancer
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To decide the optimal dose of fluorescein toduring probe based confocal endomicoscopy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Phase I
Assessment
Primary outcomes
Visibility of duodenal or colon mucosa that is examined by pCLE with using different dose of
fluorescein.
Key secondary outcomes
Adverse event with different dose of fluorescein.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Medicine |
Interventions/Control_1
Single dose adminstration of fluorescein to perform pCLE
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
| 79 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients who are scheduled to perform endoscopic resection or surgery for gastrointestinal tumors.
Written informed consent is obtained.
Laboratory data within 90 days before registration meet the criteria.
Key exclusion criteria
Contraindication to biopsy.
Patients who can not stop anticoagulants.
Allergy to fluorescein.
Patients who have the history of pheochromocytoma, malignant hypertension, severe heart failure, myocardial infarction that has occured with in 3 months, uncontrolled diabetes, severe pulmonary fibrosis, active interstitial pneumonia, uncontrolled infection.
Pregnant.
Others who are judged as inappropriate by medical doctors.
Target sample size
24
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yutaka Satio |
Organization
National Cancer Center Hospital
Division name
Endoscopy Division
Zip code
Address
5-1-1, Tsukiji, Chuo-ku, Tokyo
TEL
03-3542-2511
ytsaito@ncc.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazuya Inoki |
Organization
National Cancer Center Hospital
Division name
Endoscopy Division
Zip code
Address
5-1-1, Tsukiji, Chuo-ku, Tokyo
TEL
03-3542-2511
Homepage URL
kinoki@ncc.go.jp
Sponsor or person
Institute
National Cancer Center Hospital
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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 | 06 | Month | 12 | 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
| 2017 | Year | 01 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 02 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 06 | Month | 08 | Day |
Last modified on
| 2017 | Year | 06 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031725
| 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 |
