UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018756 |
|---|---|
| Receipt number | R000021690 |
| Scientific Title | Japan Agency for Medical Research and Development, AMED. Practical Research Project for Rare/Intractable Diseases, Advancing Care of Primary Aldosteronism in Japan Study |
| Date of disclosure of the study information | 2015/08/25 |
| Last modified on | 2019/08/26 16:21:28 |
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Basic information
Public title
Japan Agency for Medical Research and Development, AMED. Practical Research Project for Rare/Intractable Diseases,
Advancing Care of Primary Aldosteronism in Japan Study
Acronym
Japan Primary Aldosteronism Study (JPAS)
Scientific Title
Japan Agency for Medical Research and Development, AMED. Practical Research Project for Rare/Intractable Diseases,
Advancing Care of Primary Aldosteronism in Japan Study
Scientific Title:Acronym
Japan Primary Aldosteronism Study (JPAS)
Region
| Japan |
Condition
Condition
Primary Aldosteronsim: PA
Classification by specialty
| Medicine in general | Cardiology | Endocrinology and Metabolism |
| Nephrology | Endocrine surgery | Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To improve quality of clinical practice of PA and to establish evidence for the clinical guideline of severe form of PA based on 3 clinical questions as followed;
1) prediction score for subtype diagnosis of PA by non-invasive methods,2) standard protocol and decision criteria of adrenal venous sampling(AVS), 3) difference of the effects between surgical and medical treatments of PA, 4)development of highological biomarkers for diagnosis
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
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, results of confirmatory testing, CT
2) protocol and decision criteria of AVS
3) effects of surgical and medical treatment of PA
4) post-operative 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 informations, Laboratory data
4)Immunohistochemical staining
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 and underwent AVS between January 2006 and Dec 2017 in Kyoto Medical Center and JPAS participating centers
Key exclusion criteria
Patients who were judged not eligible for the study by respective attending physician
Target sample size
3500
Research contact person
Name of lead principal investigator
| 1st name | Naruse |
| Middle name | |
| Last name | Mitsuhide |
Organization
National Hospital Organization, Kyoto Medical Center
Division name
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
japan.pa.registry@gmail.com
Public contact
Name of contact person
| 1st name | Naruse |
| Middle name | |
| Last name | Mitsuhide |
Organization
National Hospital Organization, Kyoto Medical Center
Division name
Clinical Research Institute for Endocrine and Metabolic Disorders
Zip code
612-8555
Address
1-1Fukakusa-Mukaihatacho, Fushimiku, Kyoto, 612-8555, Japan
TEL
075-641-9161
Homepage URL
http://portal.e-trial.co.jp/adrenal/
japan.pa.registry@gmail.com
Sponsor or person
Institute
National Hospital Organization, Kyoto Medical Center
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development, AMED. Practical Research Project for Rare/Intractable Diseases
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Hospital Organization, Kyoto Medical Center
Address
1-1Fukakusa-Mukaihatacho, Fushimiku, Kyoto, 612-8555, Japan
Tel
075-641-9161
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）
大分大学（大分）
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）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 08 | Month | 25 | 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
3000
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
No longer recruiting
Date of protocol fixation
| 2015 | Year | 05 | Month | 18 | Day |
Date of IRB
| 2015 | Year | 05 | Month | 18 | Day |
Anticipated trial start date
| 2015 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
| 2021 | Year | 12 | Month | 01 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Multicenter, observation study.
Management information
Registered date
| 2015 | Year | 08 | Month | 21 | Day |
Last modified on
| 2019 | Year | 08 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021690
