UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050256 |
|---|---|
| Receipt number | R000057234 |
| Scientific Title | Development of a new adjunctive diagnostic method for Cushing's syndrome |
| Date of disclosure of the study information | 2023/02/07 |
| Last modified on | 2023/08/19 22:53:19 |
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Basic information
Public title
Development of a new adjunctive diagnostic method for Cushing's syndrome
Acronym
Development of a new adjunctive diagnostic method for Cushing's syndrome
Scientific Title
Development of a new adjunctive diagnostic method for Cushing's syndrome
Scientific Title:Acronym
Development of a new adjunctive diagnostic method for Cushing's syndrome
Region
| Japan |
Condition
Condition
Cunshing's syndrome
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to establish a novel adjunctive diagnostic method for Cushing's syndrome using abdominal CT scan.
Basic objectives2
Others
Basic objectives -Others
The purpose of this study is to establish a novel adjunctive diagnostic method for Cushing's syndrome using abdominal CT scan.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Diagnostic performance of Iliopsoas muscle-visceral fat ratio and PMI for Cushing's syndrome (ROC-AUC, sensitivity, specificity, etc.)
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
| 50 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
(1) Patients with adrenal tumor confirmed by abdominal CT and hormone tests (ACTH, cortisol, etc.) at institutions participating in this study
(2) Women whose age is 50 years or older
(3) Patients diagnosed with Cushing's syndrome or non-functioning adrenal tumor
Key exclusion criteria
(1) Patients with highly active malignant tumors
(2) Patients taking synthetic steroids
(3) Patients with chronic renal failure, chronic heart failure, chronic obstructive pulmonary disease, liver cirrhosis, collagen disease, inflammatory bowel disease, neuromuscular disease, ascites effusion, or scoliosis as comorbid conditions
(4) Patients who are heavy drinkers of alcohol or bedridden as their life history
(5) Other patients who are deemed inappropriate as research subjects by the investigator.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Hideki |
| Middle name | |
| Last name | Yamaguchi |
Organization
University of Miyazaki
Division name
Division of Hematology, Diabetes, and Endocrinology, Department of Internal Medicine, Faculty of Medicine
Zip code
8891692
Address
5200 Kihara, Kiyotake, Miyazaki 889-1692, Japan
TEL
0985-85-9121
yamahide@med.miyazaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Taisuke |
| Middle name | |
| Last name | Uchida |
Organization
University of Miyazaki
Division name
Division of Hematology, Diabetes, and Endocrinology, Department of Internal Medicine
Zip code
889-1692
Address
5200 Kihara Kiyotake, Miyazaki 889-1692 Japan.
TEL
0985859121
Homepage URL
taisuke_uchida@med.miyazaki-u.ac.jp
Sponsor or person
Institute
University of Miyazaki
Institute
Department
Personal name
Funding Source
Organization
University of Miyazaki
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
University of Miyazaki Hospital, Clinical Research Support Center
Address
5200 Kihara, Kiyotake, Miyazaki 889-1692, Japan
Tel
0985-85-9403
rinken@med.miyazaki-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
宮崎大学
久留米大学
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 02 | Month | 07 | 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
47
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
| 2021 | Year | 07 | Month | 21 | Day |
Date of IRB
| 2021 | Year | 08 | Month | 20 | Day |
Anticipated trial start date
| 2021 | Year | 08 | Month | 21 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
A retrospective cross-sectional observational study will be conducted in patients with abdominal CT scan confirming the presence of adrenal tumors, comparing patients with Cushing's syndrome with those with nonfunctioning adrenal tumors. Age, sex, height, weight, hormone test values, and CT images of the patients concerned will be obtained from the electronic medical record. The obtained information will be analyzed using statistical analysis software.
Management information
Registered date
| 2023 | Year | 02 | Month | 07 | Day |
Last modified on
| 2023 | Year | 08 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057234
