UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042069 |
|---|---|
| Receipt number | R000048009 |
| Scientific Title | LCI-Determining Objectively factor of Tumor by Color space, which is Objective Measure study |
| Date of disclosure of the study information | 2020/10/10 |
| Last modified on | 2021/04/19 10:37:09 |
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Basic information
Public title
LCI-Determining Objectively factor of Tumor by Color space, which is Objective Measure study
Acronym
LCI.com study
Scientific Title
LCI-Determining Objectively factor of Tumor by Color space, which is Objective Measure study
Scientific Title:Acronym
LCI.com study
Region
| Japan |
Condition
Condition
early gastric cancer
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To study the characteristics of gastric cancer that are difficult to detect by endoscopy
Basic objectives2
Others
Basic objectives -Others
Usefulness of LCI for cancers that are difficult to detect
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Clinicopathological features of gastric cancer that are difficult to detect
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
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
gastric cancer which is maximum lesion diameter is 30 mm or less
Key exclusion criteria
1)type0-I gastric cancer
2)post gastrectomy cases
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Kensuke |
| Middle name | |
| Last name | Fukuda |
Organization
Oita University
Division name
Department of Gastroenterology
Zip code
8795593
Address
1-1, idaigaoka, Hasama, Yufu, Oita
TEL
0975866193
kensuke19810103@oita-u.ac.jp
Public contact
Name of contact person
| 1st name | Kensuke |
| Middle name | |
| Last name | Fukuda |
Organization
Oita university
Division name
Department of Gastroenterology
Zip code
8795593
Address
1-1, idaigaoka, Hasama, Yufu, Oita
TEL
0975866193
Homepage URL
kensuke19810103@oita-u.ac.jp
Sponsor or person
Institute
Oita university
Institute
Department
Personal name
Funding Source
Organization
Oita university
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
General Clinical Research Center, Oita University Hospital
Address
1-1, idaigaoka, Hasama, Yufu, Oita
Tel
0975866193
gcrcjimu@oita-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
熊本大学病院（熊本県）、長崎大学病院（長崎県）、佐賀大学医学部附属病院（佐賀県）、春回会井上病院（長崎県）、宮崎大学医学部附属病院（宮崎県）、琉球大学病院（沖縄県）、嬉野医療センター（佐賀県）、如水会今村病院（佐賀県）、鹿児島大学病院（鹿児島県）、福岡大学筑紫病院（福岡県）、九州大学病院（福岡県）、九州医療センター（福岡県）、北九州市立医療センター（福岡県）、原三信病院（福岡県）、大分赤十字病院（大分県）
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 10 | Month | 10 | 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
| 2020 | Year | 08 | Month | 31 | Day |
Date of IRB
| 2020 | Year | 08 | Month | 31 | Day |
Anticipated trial start date
| 2020 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Multi-center collaborative study
Management information
Registered date
| 2020 | Year | 10 | Month | 09 | Day |
Last modified on
| 2021 | Year | 04 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048009
| 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 |
