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UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000015608
Receipt No. 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 2019/01/02

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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
Obsterics 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 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takuya Murata
Organization Kawasaki Medical School
Division name Obstetrics and gynecology 1
Zip code
Address Room301, Guranpasu, 966-2, Matsushima, Kurashiki, Okayama, Japan
TEL 090-6203-0181
Email t.muratactac@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Takuya Murata
Organization Kawasaki Medical School
Division name Obstetrics and gynecology 1
Zip code
Address 577, Matsushima, Kurashiki, Okayama, Japan
TEL 086-462-1111
Homepage URL
Email tmurata@med.kawasaki-m.ac.jp

Sponsor
Institute Kawasaki Medical School Obstetrics and gyneology 1
Institute
Department

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
Address
Tel
Email

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
Anti-cancer drug sensitivity was analyzed for subcutaneously transplanted gynecological tumors in nude mice.
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 Enrolling by invitation
Date of protocol fixation
2004 Year 10 Month 29 Day
Date of IRB
Anticipated trial start date
2014 Year 12 Month 01 Day
Last follow-up date
2020 Year 11 Month 13 Day
Date of closure to data entry
2020 Year 11 Month 13 Day
Date trial data considered complete
2020 Year 11 Month 13 Day
Date analysis concluded
2020 Year 11 Month 13 Day

Other
Other related information

Management information
Registered date
2014 Year 11 Month 05 Day
Last modified on
2019 Year 01 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018125

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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