UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000021437
Receipt number R000024726
Scientific Title Advancing Care and Pathogenesis of Intractable Adrenal diseases in Japan
Date of disclosure of the study information 2016/03/11
Last modified on 2022/03/17 10:20:10

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Basic information

Public title

Advancing Care and Pathogenesis of Intractable Adrenal diseases in Japan

Acronym

Advancing Care and Pathogenesis of Intractable Adrenal diseases in Japan

Scientific Title

Advancing Care and Pathogenesis of Intractable Adrenal diseases in Japan

Scientific Title:Acronym

Advancing Care and Pathogenesis of Intractable Adrenal diseases in Japan

Region

Japan


Condition

Condition

Pheochromocytoma, Cushing syndrome, subclinical Cushing syndrome, ACTH Independent Macronodular Adrenal Hyperplasia (AIMAH), Adrenocortical cancer, nonfunctioning adrenal tumor

Classification by specialty

Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

1) To build a registration system and a cohort for patients with adrenal tumors, 2) to produce new evidences of management of adrenal tumors contribute to clinical guidelines.

Basic objectives2

Others

Basic objectives -Others

To organize a multi-institutional study group,

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Relationship between clinical findings (baseline characteristics, hormonal data, imaging findings or treatments) and clinical course or prognosis.

Key secondary outcomes



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 pheochromocytoma, Cushing syndrome, subclinical Cushing syndrome, ACTH independent macronodular adrenal hyperplasia (AIMAH), adrenocortical cancer, and nonfunctioning adrenal tumor in department of diabetes, endocrinology and metabolism, national center for global health and medicine and collaborated institutes from Jan, 2006 to Dec, 2015.

Key exclusion criteria

Patients who were considered as unsuitable for this study.

Target sample size

1050


Research contact person

Name of lead principal investigator

1st name Akiyo
Middle name
Last name Tanabe

Organization

National Center for Global Health and Medicine

Division name

Department of Diabetes, Endocrinology and Metabolism

Zip code

1628655

Address

1-21-1, Toyama, Shinjuku-ku, Tokyo

TEL

03-3202-7181

Email

atanabe@hosp.ncgm.go.jp


Public contact

Name of contact person

1st name Akiyo
Middle name
Last name Tanabe

Organization

National Center for Global Health and Medicine

Division name

Department of Diabetes, Endocrinology and Metabolism

Zip code

1628655

Address

1-21-1, Toyama, Shinjuku-ku, Tokyo

TEL

03-3202-7181

Homepage URL


Email

atanabe@hosp.ncgm.go.jp


Sponsor or person

Institute

National Center for Global Health and Medicine

Institute

Department

Personal name



Funding Source

Organization

National Center for Global Health and Medicine

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

National Center for Global Health and Medicine

Address

1-21-1, Toyama, Shinjuku-ku, Tokyo

Tel

03-3202-7181

Email

kenkyu-shinsa@hosp.ncgm.go.jp


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



Other administrative information

Date of disclosure of the study information

2016 Year 03 Month 11 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

2015 Year 12 Month 21 Day

Date of IRB

2016 Year 09 Month 05 Day

Anticipated trial start date

2016 Year 09 Month 06 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

Observational study


Management information

Registered date

2016 Year 03 Month 11 Day

Last modified on

2022 Year 03 Month 17 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024726


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name