UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004151 |
|---|---|
| Receipt number | 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 15:48:17 |
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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
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
mnaruse@kyotolan.hosp.go.jp
Sponsor or person
Institute
Ministry of Health, Labour and Welfare ,
The Japan Endocrine Society
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004984
