UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000032525
Receipt No. R000037096
Scientific Title Japan Agency for Medical Research and Development, AMED.Practical Research Project for Rare/Intractable Diseases,Japan Rare/Intractable Adrenal Diseases Study
Date of disclosure of the study information 2018/05/15
Last modified on 2019/05/14

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
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
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

Objectives
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

Assessment
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

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
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

Eligibility
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 to Dec, 2018.
Key exclusion criteria Patients who were judged not eligible for the study by respective attending physician
Target sample size 6500

Research contact person
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

Public contact
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

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

Funding Source
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

Other related organizations
Co-sponsor National Center for Global Health and Medicine
Name of secondary funder(s)

IRB Contact (For public release)
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
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
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)

Other administrative information
Date of disclosure of the study information
2018 Year 05 Month 15 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 Enrolling by invitation
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 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Multicenter, observation study

Management information
Registered date
2018 Year 05 Month 09 Day
Last modified on
2019 Year 05 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037096

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.