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

Email

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


Email

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


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



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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name