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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004151
Receipt No. R000004984
Scientific Title Nationwide Cohort study on the development of diagnosis and treatment of pheochromocytoma in Japan
Date of disclosure of the study information 2010/09/03
Last modified on 2016/03/02

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Basic information
Public title Nationwide Cohort study on the development of diagnosis and treatment of pheochromocytoma in Japan
Acronym PHEO-J
Scientific Title Nationwide Cohort study on the development of diagnosis and treatment of pheochromocytoma in Japan
Scientific Title:Acronym PHEO-J
Region
Japan

Condition
Condition Pheochromocytoma
Classification by specialty
Medicine in general Endocrinology and Metabolism Hematology and clinical oncology
Nephrology Surgery in general Gastrointestinal surgery
Hepato-biliary-pancreatic surgery Endocrine surgery Pediatrics
Urology Radiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The aim of the study is to establish disease registry for elucidation of the effects of treatments and prognosis and to establish the early diagnostic method with histopathological markers.
Basic objectives2 Others
Basic objectives -Others prognosis of the disease
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes 1.Elucidation of the therapeutic effects and prognosis by establishing disease registry.
2. Establishment of the early diagnostic method by central analysis of histopathological markers.
Key secondary outcomes Improvement of the prognosis of pheochromocytoma

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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients with pheochromocytoma who visited outpatient clinics and hospitals during April 1, 2008 to March 31, 2012
Key exclusion criteria 1)patients not visited during the specified period.
2)patients treated at those specified outpatients clinics and hospitals.
3)patient who does not full-fill the diagnostic criteria.
Target sample size 2500

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Mitsuhide Naruse
Organization National Hospital Organization, Kyoto Medical Center
Division name Department of Endocrinology, Clinical Research Institute for Endocrine and Metabolic Diseases
Zip code
Address 1-1 Fukakusa-Mukaihatacho, Fushimiku, 612-8555 Kyoto, Japan
TEL 075-641-9161
Email

Public contact
Name of contact person
1st name
Middle name
Last name Mitsuhide Naruse
Organization National Hospital Organization, Kyoto Medical Center
Division name Department of Endocrinology, Clinical Research Institute for Endocrine and Metabolic Diseases
Zip code
Address 1-1 Fukakusa-Mukaihatacho, Fushimiku, Kyoto, 612-8555 Japan
TEL 075-641-9161
Homepage URL
Email mnaruse@kyotolan.hosp.go.jp

Sponsor
Institute Ministry of Health, Labour and Welfare ,
The Japan Endocrine Society
Institute
Department

Funding Source
Organization Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor Pheochromocytoma Research Group
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 国立病院機構京都医療センター(京都府)、札幌医科大学(北海道)、東北大学(宮城県)、福島県立医科大学(福島県)、群馬大学(群馬県)、東京女子医科大学(東京都)、東京医科歯科大学(東京都)、東京大学(東京都)、慶應義塾大学(東京都)、聖マリアンナ医科大学 横浜市西部病院(神奈川県)、信州大学(長野県)、筑波大学(茨城県)、浜松医科大学(静岡県)、福井大学(福井県)、京都大学(京都府)、大阪大学(大阪府)、高知大学(高知県)、九州大学(福岡県)、関西医科大学(大阪府)、金沢大学(石川県)、北海道大学(北海道)、国立病院機構 函館病院(北海道)、虎の門病院(東京都)、旭川医科大学(北海道)、山梨大学(山梨県)、国立国際医療センター研究所(東京都)、手稲渓仁会病院(北海道)、国立病院機構埼玉病院(埼玉県)、横浜労災病院(神奈川県)

Other administrative information
Date of disclosure of the study information
2010 Year 09 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 Completed
Date of protocol fixation
2010 Year 06 Month 14 Day
Date of IRB
Anticipated trial start date
2010 Year 08 Month 01 Day
Last follow-up date
2013 Year 03 Month 31 Day
Date of closure to data entry
2014 Year 03 Month 31 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information Multicenter, observation study.

Management information
Registered date
2010 Year 09 Month 02 Day
Last modified on
2016 Year 03 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004984

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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