UMIN-CTR Clinical Trial

Basic information
Public title	Clinical evaluation of the new quick cortisol measurement kit (QCA) at adrenal vein sampling in patients with primary aldosteronism
Acronym	Clinical evaluation of AVS-QCA
Scientific Title	Clinical evaluation of the new quick cortisol measurement kit (QCA) at adrenal vein sampling in patients with primary aldosteronism
Scientific Title:Acronym	Clinical evaluation of AVS-QCA
Region	Japan

Condition
Condition	Primary aldosteronism
Classification by specialty	Cardiology Endocrinology and Metabolism Radiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the clinical significance (sensitivity and specificity) of the new quick cortisol assay kit at adrenal vein sampling in patients with primary aldosteronism, and to assess the correlation in comparison with conventional cortisol assay
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase	Phase III

Assessment
Primary outcomes	To evaluate the clinical sensitivity and clinical specificity of the new quick cortisol assay kit, and to assess the correlation in comparison with conventional cortisol assay
Key secondary outcomes	QCA measurement time Repetition measurement rate of the QCA measurement Complete failure rate of the QCA measurement

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	Not applicable
Gender	Male and Female
Key inclusion criteria	The patients who considered surgical treatment for primary aldosteronism The patients that written informed consent was obtained
Key exclusion criteria	1) The PA patients who do not hope for surgery 2) The patients who are taking spcific drugs (including the steroid) which affect a plasma aldosterone concentration and a plasma cortisol concentration 3) the patients with allergy for a natural rubber, cosyntropin and the iodocontrast media 4) The patients with unstable angina 5) The patients with the serious hepatic disorder (AST(GOT) or ALT (GPT) more than 100IU/L) 6) The patients with the pregnant or pregnant likelihood 7) The patients who are treated with malignant disorder except for the adrenal cancer 8) The patients with severe renal dysfunction (eGFR <20mL/min/1.73m2) 9) The patients who participated in other clinical trials within three months before AVS 10) The patients who were judged to be inadequate as study patients
Target sample size	48

Research contact person
Name of lead principal investigator	1st name Takashi Middle name Last name Yoneda
Organization	Kanazawa University Hospital
Division name	Division of Endocrinology and Metabolism
Zip code	920-8641
Address	Takara-machi 13-1, Kanazawa, Ishikawa
TEL	076-265-2252
Email	endocrin@med.kanazawa-u.ac.jp

Public contact
Name of contact person	1st name Mitsuhiro Middle name Last name Kometani
Organization	Kanazawa University Hospital
Division name	Division of Endocrinology and Metabolism
Zip code	920-8641
Address	Takara-machi 13-1, Kanazawa, Ishikawa
TEL	076-265-2252
Homepage URL
Email	mkome@med.kanazawa-u.ac.jp

Sponsor
Institute	Kanazawa University
Institute
Department

Funding Source
Organization	Trustmedical Co.,Ltd
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Kanazawa University Hospital Institutional Review Board
Address	Takara-machi 13-1, Kanazawa, Ishikawa
Tel	076-265-2090
Email	irb@adm.kanazawa-u.ac.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	2019 Year 06 Month 25 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	48
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	No longer recruiting
Date of protocol fixation	2019 Year 02 Month 13 Day
Date of IRB	2019 Year 03 Month 14 Day
Anticipated trial start date	2019 Year 06 Month 26 Day
Last follow-up date	2022 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Using a blood sample obtained by adrenal vein sampling, we measure a serum cortisol level with a new quick cortisol measurement kit.

Management information
Registered date	2019 Year 06 Month 25 Day
Last modified on	2021 Year 04 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042322