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

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 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


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

Value
https://center6.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