UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038560 |
|---|---|
| Receipt number | R000043940 |
| Scientific Title | Assessment of Evaluation of tumor cell content ratio using endocytoscopy in biopsy tissue. |
| Date of disclosure of the study information | 2019/11/13 |
| Last modified on | 2019/11/13 16:12:57 |
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Basic information
Public title
Assessment of Evaluation of tumor cell content ratio using endocytoscopy in biopsy tissue.
Acronym
ECS4
Scientific Title
Assessment of Evaluation of tumor cell content ratio using endocytoscopy in biopsy tissue.
Scientific Title:Acronym
ECS4
Region
| Japan |
Condition
Condition
Lung cancer
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Endocytoscopy (ECS) is used to evaluate the tumor cell content on the spot using tissue specimens removed by bronchoscopy.
Evaluate the rate of agreement with the tumor cell content of tissue samples submitted for pathological examination.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Is it possible to evaluate tumor cell content using ECS?
Key secondary outcomes
Is it possible to estimate the presence of malignant findings and tumor cell content by imprint cytology of tissue specimens?
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Maneuver |
Interventions/Control_1
1/3 of the obtained tissue specimen is immersed in 10% formalin for 30 seconds and semi-fixed, and then 0.5% methylene blue is applied.
Do not use a tissue sample that is considered impossible to cut out and evaluate 1/3 because the sample obtained is small.
Immediately after that, the tip of the ECS is brought into contact with the lesion, and an ultra-enlarged image of the specimen is observed to preserve the image findings.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) A case of bronchoscopy using EBUS-GS for localized lung disease.
2) Cases where a sufficient amount of tissue specimen that can be evaluated by ECS and pathological examination is expected to be obtained.
3) Age at consent is over 20 years old.
4) Explanation of the participation in the study is fully explained verbally and verbally, and consent is obtained in writing from the person.
Key exclusion criteria
1) Cases judged by the attending physician / inspection physician as inappropriate.
Target sample size
32
Research contact person
Name of lead principal investigator
| 1st name | JUNRO |
| Middle name | |
| Last name | UMEMOTO |
Organization
Shimane University
Division name
Respiratory medicine
Zip code
693-8501
Address
89-1 Enya-cho, Izumo-shi, Shimane
TEL
0853-20-2580
jume@med.shimane-u.ac.jp
Public contact
Name of contact person
| 1st name | JUNRO |
| Middle name | |
| Last name | UMEMOTO |
Organization
Shimane University
Division name
Respiratory medicine
Zip code
693-8501
Address
89-1 Enya-cho, Izumo-shi, Shimane
TEL
0853-20-2580
Homepage URL
jume@med.shimane-u.ac.jp
Sponsor or person
Institute
Shimane University
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Shimane University
Address
89-1 Enya-cho, Izumo-shi, Shimane
Tel
0853-88-3056
kenkyu@med.shimane-u.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
| 2019 | Year | 11 | Month | 13 | 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
| 2019 | Year | 11 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2019 | Year | 11 | Month | 13 | Day |
Last follow-up date
| 2021 | 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
| 2019 | Year | 11 | Month | 12 | Day |
Last modified on
| 2019 | Year | 11 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043940
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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