UMIN-CTR Clinical Trial

Public title

Japan Agency for Medical Research and Development, AMED.Practical Research Project for Rare/Intractable Diseases,Japan Rare/Intractable Adrenal Diseases Study

Acronym

JRAS

Scientific Title

Japan Agency for Medical Research and Development, AMED.Practical Research Project for Rare/Intractable Diseases,Japan Rare/Intractable Adrenal Diseases Study

Scientific Title:Acronym

JRAS

Region

Japan

Asia(except Japan)

Condition

Primary Aldosteronsim, Pheochromocytoma/Paraganglioma, Cushing syndrome, subclinical Cushing syndrome, ACTH-Independent Macronodular Adrenal Hyperplasia (AIMAH), nonfunctioning adrenal tumor

Classification by specialty

Medicine in general	Endocrinology and Metabolism	Endocrine surgery
Urology

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To improve quality of clinical practice and to establish evidence for the clinical guideline of Adrenal diseases.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

1) baseline informations(age, sex, duration of hypertension, family history, past history, comorbidity, medications, symptoms, height, weight, blood pressure, pulse rate), biochemical data, endocrine tests, Imaging
2) protocol and decision criteria of AVS
3) surgical and medical treatment
4) clinical outcomes

Key secondary outcomes

1)Pathological findings
2)Markers of target organ damage:Kidney(eGFR,BUN,Cr),Heart(ECG,CTR)
3)Clinical course(6M,1Y,3Y,5Y):base line information, Laboratory data
4)Imaging

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

Purpose of intervention

Type of intervention

Interventions/Control_1

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

Age-lower limit

20

years-old

<=

Age-upper limit

90

years-old

>=

Gender

Male and Female

Key inclusion criteria

Patients who were diagnosed as PA, pheochromocytoma/paraganglioma, Cushing syndrome, subclinical Cushing syndrome, ACTH-independent macronodular adrenal hyperplasia (AIMAH), and nonfunctioning adrenal tumor in Kyoto Medical Center and collaborated centers from Jan, 2006.

Key exclusion criteria

Patients who were judged not eligible for the study by respective attending physician

Target sample size

8000

Name of lead principal investigator

1st name	Mitsuhide
Middle name
Last name	Naruse

Organization

National Hospital Organization, Kyoto Medical Center

Division name

Adrenal Project, Clinical Research Institute for Endocrine and Metabolic Diseases

Zip code

612-8555

Address

1-1Fukakusa-Mukaihatacho, Fushimiku, Kyoto, 612-8555, Japan

TEL

075-641-9161

Email

japan.pa.registry@gmail.com

Name of contact person

1st name	Mitsuhide
Middle name
Last name	Naruse

Organization

National Hospital Organization, Kyoto Medical Center

Division name

Adrenal Project, Clinical Research Institute for Endocrine and Metabolic Diseases

Zip code

612-8555

Address

1-1 Fukakusa-Mukaihatacho, Fushimiku, Kyoto 612-8555, Japan

TEL

075-641-9161

Homepage URL

Email

japan.pa.registry@gmail.com

Institute

NHO Kyoto Medical Center, Adrenal Project, Clinical Research Institute for Endocrine and Metabolic Diseases

Institute

Department

Personal name

Organization

Japan Agency for Medical Research and development, AMED.
Practical Research Project for Rare/Intractable Diseases

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Japan

Co-sponsor

National Center for Global Health and Medicine

Name of secondary funder(s)

Organization

NHO Kyoto Medical Center

Address

1-1 Fukakusa-Mukaihatacho, Fushimiku, Kyoto, 612-8555, Japan

Tel

075-641-9161

Email

japan.pa.registry@gmail.com

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

国立病院機構京都医療センター(京都)
聖マリアンナ医科大学（神奈川）　　　　　　　
大阪大学（大阪）　　　　　　　　　
應義塾大学（東京）　　　　　　　　　　　　
京都大学（京都）　　　　　　　
東京医科歯科大学（東京）　　　　　　　　　　
群馬大学（群馬）　　　　　　　　　　　　
熊本大学（熊本）　　　　　　　　　　　　
東京大学(東京）　　　　　　　　　　　　
金沢大学（金沢）　　　　　　　　
福島県立医科大学（福島）　　　　　
国立国際医療研究センター(東京）　
明石医療センター(兵庫）
三田市民病院(兵庫）
JR広島病院(広島）
松山赤十字病院(愛媛）
さくら会病院(大阪）
国立病院機構九州医療センター(福岡）
市立札幌病院(北海道）
済生会横浜東部病院 (神奈川）
太田総合病院（福島）
北里大学（神奈川）
鳥取大学（鳥取）
岡崎市民病院（愛知）
天理よろづ病院（奈良）
日本大学（東京）
九州大学病院（福岡）
武蔵野赤十字病院（東京）
JCHO九州病院（福岡）
済生会福岡総合病院（福岡）
藤田保健衛生大学（愛知県）
東北医科薬科大学（宮城県）
水戸済生会総合病院(茨木県）
三重大学医学部附属病院（三重県）
順天堂大学大学院（東京都）
横浜市立大学附属病院　福浦本院（神奈川県）
横浜市立大学総合医療センター病院（神奈川県）
済生会横浜市南部病院（神奈川県）
東海中央病院（岐阜県）
京都府立医科大学（京都）
兵庫医科大学（兵庫）
岐阜大学（岐阜）
旭川厚生病院（北海道）
川崎医科大学（岡山県）
広島大学（広島県）
神戸大学（兵庫県）
高知大学（高知県）
松坂市民病院（三重県）
神戸大学(兵庫県）
奈良県立医科大学(奈良県）

Date of disclosure of the study information

2018

Year

05

Month

15

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

No longer recruiting

Date of protocol fixation

2018

Year

03

Month

26

Day

Date of IRB

2018

Year

04

Month

16

Day

Anticipated trial start date

2018

Year

04

Month

01

Day

Last follow-up date

2021

Year

07

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Multicenter, observation study

Registered date

2018

Year

05

Month

09

Day

Last modified on

2020

Year

12

Month

25

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037096