UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015819 |
|---|---|
| Receipt number | R000018412 |
| Scientific Title | The molecular biological analysis of cell line and Xenograft line establishment and drug susceptibility of gastrointestinal stromal tumors |
| Date of disclosure of the study information | 2014/12/02 |
| Last modified on | 2019/12/23 09:31:34 |
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Basic information
Public title
The molecular biological analysis of cell line and Xenograft line establishment and drug susceptibility of gastrointestinal stromal tumors
Acronym
The molecular biological analysis of cell line and Xenograft line establishment and drug susceptibility of gastrointestinal stromal tumors
Scientific Title
The molecular biological analysis of cell line and Xenograft line establishment and drug susceptibility of gastrointestinal stromal tumors
Scientific Title:Acronym
The molecular biological analysis of cell line and Xenograft line establishment and drug susceptibility of gastrointestinal stromal tumors
Region
| Japan |
Condition
Condition
Gastrointestinal stromal tumors (GIST)
Classification by specialty
| Gastroenterology | Surgery in general | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To establish cell line and Xenograft line from surgical specimen in order to survey clinical condition or drug resistance of gastrointestinal stromal tumors
Basic objectives2
Others
Basic objectives -Others
To identify and analyze of tumor growth and molecule related to drug sensitivity from established cell line and Xenograft line
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To establish cell line and Xenograft line from surgical specimen in order to survey clinical condition or drug resistance of gastrointestinal stromal tumors
Key secondary outcomes
Base
Study type
Others,meta-analysis etc
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
Patients undergoing surgery with gastrointestinal stromal tumors (GIST)
Key exclusion criteria
1. PS 3 or 4
2. Infancy
3. Apparent tumor residual
4. Patients with congenital or acquired coagulation defect
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | Yuko |
| Middle name | |
| Last name | Kitagawa |
Organization
Keio University School of Medicine
Division name
Department of Surgery
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, Japan
TEL
03-3353-1211
kitagawa@a3.keio.jp
Public contact
Name of contact person
| 1st name | Kazumasa |
| Middle name | |
| Last name | Fukuda |
Organization
Keio University School of Medicine
Division name
Department of Surgery
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, Japan
TEL
03-3353-1211
Homepage URL
fukudak@z6.keio.jp
Sponsor or person
Institute
Department of Surgery, Keio University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Surgery, Keio University School of Medicine
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
Keio University School of Medicine, Ethics Committee
Address
35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, Japan
Tel
03-5363-3503
med-rinri-jimu@adst.keio.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
| 2014 | Year | 12 | Month | 02 | 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
Terminated
Date of protocol fixation
| 2013 | Year | 09 | Month | 11 | Day |
Date of IRB
| 2013 | Year | 11 | Month | 25 | Day |
Anticipated trial start date
| 2014 | Year | 12 | Month | 02 | Day |
Last follow-up date
| 2019 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To harvest 1 to 5 mm surgical specimen
Management information
Registered date
| 2014 | Year | 12 | Month | 02 | Day |
Last modified on
| 2019 | Year | 12 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018412
