UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059863 |
|---|---|
| Receipt number | R000068456 |
| Scientific Title | Development to localize endocrine tumors using cell-free DNA obtained from tumor venous blood sampling |
| Date of disclosure of the study information | 2025/11/23 |
| Last modified on | 2025/11/23 20:32:32 |
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Basic information
Public title
Development to localize endocrine tumors using cell-free DNA obtained from tumor venous blood sampling
Acronym
Localization of endocrine tumors using cell-free DNA
Scientific Title
Development to localize endocrine tumors using cell-free DNA obtained from tumor venous blood sampling
Scientific Title:Acronym
Localization of endocrine tumors using cell-free DNA
Region
| Japan |
Condition
Condition
Primary aldsteronism,or Cushing disease
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
In venous sampling for diagnosing the localization of endocrine tumors including primary aldosteronism and Cushing's disease, we mesure circulating tumor DNA (cell-free DNA: cfDNA) in addition to measuring hormone levels to improve the accuracy of tumor localization.
Basic objectives2
Others
Basic objectives -Others
NA
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Increace in rate of tumor localization by adding genetic analyses using cell-free DNA obtained from tumor venous sampling in patients with primary aldsteronism or Cushing disease.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Patients with an endocrinological diagnosis of primary aldosteronism or Cushing's disease who will undergo AVS or IPS/CS sampling for the purpose of localization.
2. Patients aged 18 years or older.
3. Patients who have received a thorough explanation of participation in this study and have provided their voluntary written consent with a full understanding.
Key exclusion criteria
1. Pregnant or lactating patients
2. Patients in whom it is difficult to collect an additional 5 ml of blood from each of the left and right (or central/peripheral) venous sampling sites
3. Patients who are otherwise deemed inappropriate for this study by the principal investigator.
Target sample size
102
Research contact person
Name of lead principal investigator
| 1st name | Ichiro |
| Middle name | |
| Last name | Horie |
Organization
Nagasaki University Hospital
Division name
Endocrinology and Metabolism
Zip code
852-8501
Address
1-7-1 Sakamoto, Nagasaki, Japan
TEL
0958197464
horie@nagasaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Ichiro |
| Middle name | |
| Last name | Horie |
Organization
Nagasaki University Hospital
Division name
Endocrinology and Metabolism
Zip code
852-8501
Address
1-7-1 Sakamoto, Nagasaki
TEL
0958197464
Homepage URL
horie@nagasaki-u.ac.jp
Sponsor or person
Institute
Nagasaki University Hospital
Institute
Department
Personal name
Funding Source
Organization
Nagasaki University Hospital
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
Nagasaki University Hospital
Address
1-7-1 Sakamoto, Nagasaki
Tel
0958197464
horie@nagasaki-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
| 2025 | Year | 11 | Month | 23 | 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
| 2025 | Year | 11 | Month | 06 | Day |
Date of IRB
| 2025 | Year | 11 | Month | 06 | Day |
Anticipated trial start date
| 2025 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2031 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
NA
Management information
Registered date
| 2025 | Year | 11 | Month | 23 | Day |
Last modified on
| 2025 | Year | 11 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068456
