UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033401 |
|---|---|
| Receipt number | R000038080 |
| Scientific Title | Construction of an in vitro evaluation system for novel aldosterone production inhibitors using cells derived from aldosterone producing adenomas (Sample provision to Pharmaceutical Research Department, NISSAN CHEMICAL CO., LTD.) |
| Date of disclosure of the study information | 2018/08/03 |
| Last modified on | 2020/08/05 11:17:33 |
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Basic information
Public title
Construction of an in vitro evaluation system for novel aldosterone production inhibitors using cells derived from aldosterone producing adenomas (Sample provision to Pharmaceutical Research Department, NISSAN CHEMICAL CO., LTD.)
Acronym
Construction of an in vitro evaluation system for novel aldosterone production inhibitors using cells derived from aldosterone producing adenomas
Scientific Title
Construction of an in vitro evaluation system for novel aldosterone production inhibitors using cells derived from aldosterone producing adenomas (Sample provision to Pharmaceutical Research Department, NISSAN CHEMICAL CO., LTD.)
Scientific Title:Acronym
Construction of an in vitro evaluation system for novel aldosterone production inhibitors using cells derived from aldosterone producing adenomas
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
| 1st name | |
| Middle name | |
| Last name | Hirotaka Asakura |
Organization
Saitama Medical University Hospital
Division name
Urology
Zip code
Address
38 Morohongo Moroyama-machi, Iruma-gun, Saitama
TEL
049-276-1111
hirotaka@saitama-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Koshiro Nishimoto |
Organization
Saitama Medical University International Medical Center
Division name
UroOncology
Zip code
Address
1397-1 Yamane, Hidaka, Saitama
TEL
042-984-4111
Homepage URL
k.nishimoto@keio.jp
Sponsor or person
Institute
Saitama Medical University International Medical Center
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Address
Tel
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 |
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
| 2018 | Year | 11 | Month | 27 | Day |
Date of IRB
| 2018 | Year | 12 | Month | 03 | Day |
Anticipated trial start date
| 2018 | Year | 12 | Month | 03 | Day |
Last follow-up date
| 2020 | Year | 07 | Month | 23 | Day |
Date of closure to data entry
| 2020 | Year | 07 | Month | 23 | Day |
Date trial data considered complete
| 2020 | Year | 07 | Month | 23 | Day |
Date analysis concluded
| 2020 | Year | 07 | Month | 23 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 07 | Month | 16 | Day |
Last modified on
| 2020 | Year | 08 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038080
