UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037157 |
|---|---|
| Receipt number | R000042322 |
| Scientific Title | Clinical evaluation of the new quick cortisol measurement kit (QCA) at adrenal vein sampling in patients with primary aldosteronism |
| Date of disclosure of the study information | 2019/06/25 |
| Last modified on | 2021/04/20 16:53:57 |
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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
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
mkome@med.kanazawa-u.ac.jp
Sponsor or person
Institute
Kanazawa University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042322
