UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022844 |
|---|---|
| Receipt number | R000026329 |
| Scientific Title | Research of mechanism and cytotoxicity of newly-developed anticancer drug for gastric cancer using human gastric cells. |
| Date of disclosure of the study information | 2016/06/22 |
| Last modified on | 2023/07/14 15:58:44 |
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Basic information
Public title
Research of mechanism and cytotoxicity of newly-developed anticancer drug for gastric cancer using human gastric cells.
Acronym
Mechanism and cytotoxicity of newly-developed anticancer drug for gastric cancer.
Scientific Title
Research of mechanism and cytotoxicity of newly-developed anticancer drug for gastric cancer using human gastric cells.
Scientific Title:Acronym
Mechanism and cytotoxicity of newly-developed anticancer drug for gastric cancer.
Region
| Japan |
Condition
Condition
Gastric cancer
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
In order to evaluate 1) anticancer effects and cytotoxicity, 2) anticancer mechanism of newly-developed anticancer drug for gastric cancer using human gastric cells which are collected by biopsy or surgery.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes of the cancer cell count after the treatment of newly-developed anticancer drug.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine | Device,equipment |
Interventions/Control_1
Biopsy sampling from gastric cancer.
Interventions/Control_2
Biopsy sampling from normal gastric mucosa.
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) The subjects who agree to participate in the study by written informed consent.
2) A patient who is diagnosed as gastric cancer or normal mucosa.
Key exclusion criteria
The subjects who are judged to be inappropriate for this study by doctors conducting the study.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Mikihiro |
| Middle name | |
| Last name | Fujiya |
Organization
Asahikawa Medical University
Division name
Division of Gastroenterology and Hematology/Oncology, Department of Medicine
Zip code
078-8510
Address
2-1-1-1, Midorigaoka-higashi Asahikawa, Hokkaido, Japan
TEL
0166-68-2462
fujiya2008@hotmail.co.jp
Public contact
Name of contact person
| 1st name | Masami |
| Middle name | |
| Last name | Ijiri |
Organization
Asahikawa Medical University
Division name
Division of Gastroenterology and Hematology/Oncology, Department of Medicine
Zip code
078-8510
Address
2-1-1-1, Midorigaoka-higashi Asahikawa, Hokkaido, Japan
TEL
0166-68-2462
Homepage URL
m-ijiri@asahikawa-med.ac.jp
Sponsor or person
Institute
Asahikawa Medical University
Institute
Department
Personal name
Funding Source
Organization
Asahikawa Medical University
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
Asahikawa Medical University Research Ethics Committee
Address
2-1-1-1, Midorigaoka-higashi Asahikawa, Hokkaido, Japan
Tel
0166-68-2187
rs-kk.g@asahikawa-med.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
| 2016 | Year | 06 | Month | 22 | 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
| 2016 | Year | 06 | Month | 15 | Day |
Date of IRB
| 2016 | Year | 06 | Month | 20 | Day |
Anticipated trial start date
| 2016 | Year | 06 | Month | 27 | 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
| 2016 | Year | 06 | Month | 22 | Day |
Last modified on
| 2023 | Year | 07 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026329
| 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 |
