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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000033401
Receipt No. R000038080
Official scientific title of the study Construction of an in vitro evaluation system for novel aldosterone production inhibitors using cells derived from aldosterone producing adenomas (APA).
Date of disclosure of the study information 2018/08/03
Last modified on 2018/10/20

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Basic information
Official scientific title of the study Construction of an in vitro evaluation system for novel aldosterone production inhibitors using cells derived from aldosterone producing adenomas (APA).
Title of the study (Brief title) Construction of an in vitro evaluation system for novel aldosterone production inhibitors using cells derived from aldosterone producing adenomas (APA).
Region
Japan

Condition
Condition Aldosterone producing adenoma
Classification by specialty
Medicine in general Endocrinology and Metabolism Endocrine surgery
Urology
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 We aim to construct an in vitro evaluation system for novel aldosterone production inhibitors using cells derived from aldosterone producing adenomas (APA) patients.
Basic objectives2 Others
Basic objectives -Others We are studying the creation of drugs with novel mechanism of action that directly suppresses APA by the evaluation system constructed in this research.
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Discovered adrenal tissue is dispersed in a single cell and aldosterone producing cells are extracted. The extracted cells are seeded on a plate, cultured for a certain period of time, the culture supernatant is collected, and the concentration of steroid containing aldosterone is measured to confirm that they are aldosterone producing cells.
Key secondary outcomes Not applicable

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 Diagnosis
Type of intervention
Other
Interventions/Control_1 Discovered adrenal tissue is dispersed in a single cell and aldosterone producing cells are extracted. Measure the concentration of steroid containing aldosterone from the extracted cells to confirm that they are aldosterone producing cells.
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 APA patients to be adrenalectomized
Key exclusion criteria Patients who did not obtain consent
Target sample size 30

Research contact person
Name of lead principal investigator Hirotaka Asakura
Organization Saitama Medical University Hospital
Division name Urology
Address 38 Morohongo Moroyama-machi, Iruma-gun, Saitama
TEL 049-276-1111
Email hirotaka@saitama-med.ac.jp

Public contact
Name of contact person Koshiro Nishimoto
Organization Saitama Medical University International Medical Center
Division name UroOncology
Address 1397-1 Yamane, Hidaka, Saitama
TEL 042-984-4111
Homepage URL
Email k.nishimoto@keio.jp

Sponsor
Institute Saitama Medical University International Medical Center
Institute
Department

Funding Source
Organization Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor Nissan Chemical Corporation Biological Research Laboratories
Name of secondary funder(s)

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
2018 Year 08 Month 03 Day

Progress
Recruitment status Preinitiation
Date of protocol fixation
2018 Year 07 Month 16 Day
Anticipated trial start date
2018 Year 08 Month 06 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information

Management information
Registered date
2018 Year 07 Month 16 Day
Last modified on
2018 Year 10 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038080

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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