UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015608 |
|---|---|
| Receipt number | R000018125 |
| Scientific Title | The reconstitution of gynecologic cancer microenvirnment-making a new therapy |
| Date of disclosure of the study information | 2014/11/07 |
| Last modified on | 2023/11/12 10:24:31 |
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Basic information
Public title
The reconstitution of gynecologic cancer microenvirnment-making a new therapy
Acronym
Reconstitution of gynecologic cancer microenvirnment
Scientific Title
The reconstitution of gynecologic cancer microenvirnment-making a new therapy
Scientific Title:Acronym
Reconstitution of gynecologic cancer microenvirnment
Region
| Japan |
Condition
Condition
Gynecologic cancer
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
Reconstitute patient's cancer tissues in vitro and in vivo. Purifying cells that exist patient's cancer microenvirnment from their cancer tissues and culture them in vitro. Patient's cancer tissue is taken from patient and is transplanted to the immunocompromised mouse orthotropically.
Anticancer drugs and molecular targeted drugs are given to the reconstitution models of the gynecological cancer and analyse sensitity of them, making a new therapy.
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
To find out the best combination of drugs that is effective for the treatment of gynecologic cancer.
To find out the cell that positioned near cancer cells and make them more malignant.
Key secondary outcomes
engraftment rate
analogy of HE stain histopathology
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Single blind -participants are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Growth inhibiting effect of cancer cells
Interventions/Control_2
Growth inhibiting effect of cancer tissues
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
Female
Key inclusion criteria
To get enough volume of cancer tissue
Key exclusion criteria
Tumor tissue is too small to make correct pathological diagnosis.
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Takuya |
| Middle name | |
| Last name | Murata |
Organization
Kawasaki Medical School
Division name
Obstetrics and gynecology
Zip code
7010192
Address
2-6-1, Nakasange, Okayama city, Okayama, Japan
TEL
0862328343
t.muratactac@gmail.com
Public contact
Name of contact person
| 1st name | Takuya |
| Middle name | |
| Last name | Murata |
Organization
Kawasaki Medical School
Division name
Obstetrics and gynecology
Zip code
7008505
Address
2-6-1, Nakasange, Okayama city, Okayama, Japan
TEL
086-232-8343
Homepage URL
tmurata@med.kawasaki-m.ac.jp
Sponsor or person
Institute
Kawasaki Medical School Obstetrics and gyneology
Institute
Department
Personal name
Funding Source
Organization
Grant-in-Aid for Scientific Research (KAKENHI)
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kawasaki medical school
Address
577, Matsushima, Kurashiki city, Okayama
Tel
0864621111
kmsrec@med.kawasaki-m.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
川崎医科大学
アンチキャンサー社
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 11 | Month | 07 | 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
A pyrole imidazole compound that inhibits the expression of a target membrane protein significantly inhibited lymph node metastasis in the co-transplantation system of nude mice.
Co-transplantation of fibroblasts and cacner cells with high expression of membrane protein into nude mice resulted in liver metastasis.
Results date posted
| 2020 | Year | 01 | Month | 29 | Day |
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
Enrolling by invitation
Date of protocol fixation
| 2004 | Year | 10 | Month | 29 | Day |
Date of IRB
| 2014 | Year | 11 | Month | 14 | Day |
Anticipated trial start date
| 2014 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2025 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2025 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2026 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 11 | Month | 05 | Day |
Last modified on
| 2023 | Year | 11 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018125
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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