UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035951 |
|---|---|
| Receipt number | R000040947 |
| Scientific Title | Validation of a novel histopathological auto-diagnosis system of gastrointestinal tumor using the tissue cleaning technology (LUCID) |
| Date of disclosure of the study information | 2019/03/01 |
| Last modified on | 2024/08/25 09:51:36 |
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Basic information
Public title
Validation of a novel histopathological auto-diagnosis system of gastrointestinal tumor using the tissue cleaning technology (LUCID)
Acronym
Validation of a histopathological auto-diagnosis system of gastrointestinal tumor using LUCID
Scientific Title
Validation of a novel histopathological auto-diagnosis system of gastrointestinal tumor using the tissue cleaning technology (LUCID)
Scientific Title:Acronym
Validation of a histopathological auto-diagnosis system of gastrointestinal tumor using LUCID
Region
| Japan |
Condition
Condition
Gastrointestinal neoplasm
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To validate a novel histopathological auto-diagnosis system of gastrointestinal tumor using the tissue cleaning technology (LUCID)
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Accuracy of histopathological diagnosis
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients underwent surgical resections of gastrointestinal neoplasms at Chiba-Nishi General Hospital from January 2017 to December 2018.
Key exclusion criteria
N/A
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Satoshi |
| Middle name | |
| Last name | Ono |
Organization
Chiba-Nishi General Hospital
Division name
Department of Gastroenterology
Zip code
270-2251
Address
107-1, Kanegasaku, Matsudo-shi, Chiba.
TEL
047-389-8111
satoshi-tky@umin.ac.jp
Public contact
Name of contact person
| 1st name | Satoshi |
| Middle name | |
| Last name | Ono |
Organization
Chiba-Nishi General Hospital
Division name
Department of Gastroenterology
Zip code
270-2251
Address
107-1, Kanegasaku, Matsudo-shi, Chiba.
TEL
047-389-8111
Homepage URL
satoshi-tky@umin.ac.jp
Sponsor or person
Institute
Department of Gastroenterology, The University of Tokyo Hospital
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
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
Tokushukai Group Institutional Review Board
Address
1-8-7, Koji-machi, Chiyoda-ku, Tokyo 102-0083, Japan
Tel
03-3263-4801
satoshi-tky@umin.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 | 03 | Month | 01 | 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 | 12 | Month | 17 | Day |
Date of IRB
| 2022 | Year | 03 | Month | 31 | Day |
Anticipated trial start date
| 2019 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observation of specimens after tissue cleaning
Management information
Registered date
| 2019 | Year | 02 | Month | 20 | Day |
Last modified on
| 2024 | Year | 08 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040947
