UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034189 |
|---|---|
| Receipt number | R000038974 |
| Scientific Title | Evaluation of exfoliated tumor cells after spcimen collection for pathology. |
| Date of disclosure of the study information | 2018/09/18 |
| Last modified on | 2024/03/28 19:12:02 |
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Basic information
Public title
Evaluation of exfoliated tumor cells after spcimen collection for pathology.
Acronym
Evaluation of exfoliated tumor cells after spcimen collection.
Scientific Title
Evaluation of exfoliated tumor cells after spcimen collection for pathology.
Scientific Title:Acronym
Evaluation of exfoliated tumor cells after spcimen collection.
Region
| Japan |
Condition
Condition
Submucosal tumor
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of exfoliated tumor cells after specimen collection for pathology.
Basic objectives2
Others
Basic objectives -Others
Evaluation of exfoliated tumor cells in gastric juce after spcimen collection for pathology using EUS-FNA or MIAB.
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The percentage of the exfoliated tumor cells.
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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. Patients with SMT who undergo EUS-FNA or endoscopic mucosal incision assisted biopsy (MIAB), and collected gastri juice.
2. Patients from whom written informed consent is obtained.
3. Patients who are older than 20 years old.
Key exclusion criteria
1. Patients who are judged as contraindication for EUS-FNA or MIAB.
2. Patients who are judged as being inappropriate for this study by their medical doctor.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | eikichi |
| Middle name | |
| Last name | Ihara |
Organization
kyushu univercity hospital
Division name
Department of Medicine and Bioregulatory Science
Zip code
851-8582
Address
3-1-1 Maidashi, Higashi-ku, Fukuoka 812-8582, Japan
TEL
0926425082
eikichi@intmed3.med.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | Yosuke |
| Middle name | |
| Last name | Minoda |
Organization
Kyushu University Graduate School of Medical Sciences
Division name
Department of Medicine and Bioregulatory Science
Zip code
851-8582
Address
3-1-1 Maidashi, Higashi-ku, Fukuoka 812-8582, Japan
TEL
0926425082
Homepage URL
yminoda@med.kyushu-u.ac.jp
Sponsor or person
Institute
kyushu univercity hospital
Institute
Department
Personal name
Funding Source
Organization
None
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
Kyushu university
Address
3-1-1 Maidashi, Higashi-ku, Fukuoka 812-8582, Japan
Tel
+810926425082
byskenkyu@jimu.kyushu-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
| 2018 | Year | 09 | Month | 18 | 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
| 2018 | Year | 09 | Month | 11 | Day |
Date of IRB
| 2018 | Year | 09 | Month | 11 | Day |
Anticipated trial start date
| 2018 | Year | 09 | Month | 12 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Obesrvation study
Management information
Registered date
| 2018 | Year | 09 | Month | 18 | Day |
Last modified on
| 2024 | Year | 03 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038974
