UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000007440
Receipt number R000008768
Scientific Title Usefulness of New Quick Cortisol Assay during Adrenal Vein Sampling in Patients with Primary Aldosteronism
Date of disclosure of the study information 2012/03/05
Last modified on 2016/03/07 10:05:50

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Basic information

Public title

Usefulness of New Quick Cortisol Assay during Adrenal Vein Sampling in Patients with Primary Aldosteronism

Acronym

New Quick Cortisol Assay during Adrenal Vein Sampling

Scientific Title

Usefulness of New Quick Cortisol Assay during Adrenal Vein Sampling in Patients with Primary Aldosteronism

Scientific Title:Acronym

New Quick Cortisol Assay during Adrenal Vein Sampling

Region

Japan


Condition

Condition

Primary aldosteronism

Classification by specialty

Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The purpose of this study is to evaluate the usefulness of new quick cortisol assay during adrenal vein sampling(AVS) in patients with primary aldosteronism(PA).

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2


Developmental phase

Not applicable


Assessment

Primary outcomes

Success rate of AVS

Key secondary outcomes

1)effects on differential diagnosis of PA.
2)effects on turn-round time of AVS.
3)rares of complications
4)cost for new quick cortisol assay


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Single blind -participants are blinded

Control

No treatment

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Diagnosis

Type of intervention

Device,equipment

Interventions/Control_1

traditional AVS

Interventions/Control_2

AVS using quick cortisol assay

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 primary aldosteronism who are candidtes for surgery

Key exclusion criteria

1)patients with primary aldosteronism who are not candidtes for surgery
2)patients under dialysis or with serum creatinine >2.5 mg/dl in men or >2.0 mg/dl in women
3)pregnancy or breast feeding
4)with malignancy
5)with severe hypersensitivity or with corticoid therapy
6)inadequacy to participate in the study, as assessed by the investigators

Target sample size

400


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yoshiyu Takeda

Organization

Kanazawa University Graduate School of Medical Science

Division name

Department of internal medicine

Zip code


Address

Takara-machi 13-1, Kanazawa, Ishikawa 920-8641, Japan

TEL

076-265-2252

Email

takeday@med.kanazawa-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Takashi Yoneda

Organization

Kanazawa University Graduate School of Medical Science

Division name

Department of internal medicine

Zip code


Address

Takara-machi 13-1, Kanazawa, Ishikawa 920-8641, Japan

TEL

076-265-2252

Homepage URL


Email

endocrin@med.kanazawa-u.ac.jp


Sponsor or person

Institute

Department of internal medicine,Kanazawa University Graduate School of Medical Science

Institute

Department

Personal name



Funding Source

Organization

Department of internal medicine,Kanazawa University Graduate School of Medical Science

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


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

芳珠記念病院(石川県)、石川県立中央病院(石川県)、石川県済生会金沢病院(石川県)、浅ノ川総合病院(石川県)、 金沢社会保険病院 (石川県)、富山赤十字病院(富山県)、高岡市民病院(富山県)、厚生連高岡病院(富山県)、三田市民病院(兵庫県)、日本原発性アルドステロン協会に属する医療機関(石川県)  


Other administrative information

Date of disclosure of the study information

2012 Year 03 Month 05 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 11 Month 30 Day

Date of IRB


Anticipated trial start date

2011 Year 12 Month 01 Day

Last follow-up date

2015 Year 03 Month 01 Day

Date of closure to data entry

2015 Year 03 Month 01 Day

Date trial data considered complete

2015 Year 03 Month 01 Day

Date analysis concluded

2015 Year 03 Month 01 Day


Other

Other related information



Management information

Registered date

2012 Year 03 Month 05 Day

Last modified on

2016 Year 03 Month 07 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008768


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name