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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000043863
Receipt No. R000050067
Scientific Title Research on the mechanism of resistance to treatment of pituitary adenomas using patient-derived organoids
Date of disclosure of the study information 2021/05/01
Last modified on 2021/04/07

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Basic information
Public title Research on the mechanism of resistance to treatment of pituitary adenomas
Acronym Research on the mechanism of resistance to treatment of pituitary adenomas
Scientific Title Research on the mechanism of resistance to treatment of pituitary adenomas using patient-derived organoids
Scientific Title:Acronym Research on the mechanism of resistance to treatment of pituitary adenomas using patient-derived organoids
Region
Japan

Condition
Condition pituitary adenoma
Classification by specialty
Endocrinology and Metabolism Neurosurgery
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 to identify the mechanism of resistance to treatment of pituitary adenomas
Basic objectives2 Others
Basic objectives -Others growth of pituitary adenomas
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes growth of pituitary adenomas
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Other
Interventions/Control_1 culture patient-derived pituitary adenomas
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria patients who underwent resection of pituitary adenoma
Key exclusion criteria 1) patients in whom enough tumor tissue was not obtained
2) patients who did not give consent
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Ryuta
Middle name
Last name Saito
Organization Nagoya university graduate school of medicine
Division name Neurosurgery
Zip code 466-8550
Address Tsurumai-cho 65, Showa-ku, Nagoya, Aichi
TEL 052-744-2355
Email ryuta@med.nagoya-u.ac.jp

Public contact
Name of contact person
1st name Yuichi
Middle name
Last name Nagata
Organization Nagoya university graduate school of medicine
Division name Neurosurgery
Zip code 466-8550
Address Tsurumai-cho 65, Showa-ku, Nagoya, Aichi
TEL 052-744-2353
Homepage URL
Email ynagata@med.nagoya-u.ac.jp

Sponsor
Institute Nagoya university graduate school of medicine
Institute
Department

Funding Source
Organization Grants-in-Aid for Scientific Research
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Nagoya University Center for advanced medicine and clinical research
Address Tsurumai-cho 65, Showa-ku, Nagoya, Aichi
Tel 052-744-2942
Email ethics@med.nagoya-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

Other administrative information
Date of disclosure of the study information
2021 Year 05 Month 01 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 Preinitiation
Date of protocol fixation
2021 Year 04 Month 07 Day
Date of IRB
Anticipated trial start date
2021 Year 05 Month 01 Day
Last follow-up date
2026 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
2021 Year 04 Month 07 Day
Last modified on
2021 Year 04 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050067

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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