UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060658 |
|---|---|
| Receipt number | R000069382 |
| Scientific Title | Optimization of cutoff values for plasma-free fractionated metanephrines in the endocrinological diagnosis of pheochromocytoma and paraganglioma: a multicenter retrospective study |
| Date of disclosure of the study information | 2026/02/13 |
| Last modified on | 2026/02/12 16:45:58 |
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Basic information
Public title
A Study on the Determination of Optimal Cutoff Values for Plasma Free Metanephrine and Normetanephrine in the Diagnosis of Pheochromocytoma Based on Real-World Clinical Practice
Acronym
Real-World Cutoff Values for Plasma Free Metanephrines for Pheochromocytoma
Scientific Title
Optimization of cutoff values for plasma-free fractionated metanephrines in the endocrinological diagnosis of pheochromocytoma and paraganglioma: a multicenter retrospective study
Scientific Title:Acronym
Optimization of plasma-free fractionated metanephrines cutoffs in pheochromocytoma and paraganglioma
Region
| Japan |
Condition
Condition
pheochromocytoma and paraganglioma
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
This study aimed to establish real-world cutoff values for plasma-free fractionated metanephrines for the diagnosis of pheochromocytoma and paraganglioma using measurements obtained in routine clinical settings.
Basic objectives2
Others
Basic objectives -Others
diagnostic test / diagnostic accuracy
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Optimal cutoff values of plasma-free metanephrine and normetanephrine for the diagnosis of pheochromocytoma and paraganglioma, determined by receiver operating characteristic (ROC) analysis.
Key secondary outcomes
1. Comparison of the diagnostic performance of plasma-free and urinary fractionated metanephrines assessed by ROC analysis (AUC, sensitivity, and specificity).
2. Comparison of changes in plasma-free fractionated metanephrine levels before and after surgery.
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
Eligible participants were adults aged 18 years or older who underwent measurement of pMN/pNMN using the 2-MET Plasma ELISA kit (SML) after its reimbursement from January 2019.
Key exclusion criteria
The following cases were excluded from the analysis based on medical record review:
(1) use of medications known to interfere with metanephrine measurements (e.g., antidepressants, atypical antipsychotics, sympathomimetic agents);
(2) ingestion of foods known to affect metanephrine measurements (e.g., caffeine-containing products, bananas, or vanilla) on the day of blood sampling;
(3) specimen collection performed during the treatment of acute illnesses or other clinical conditions likely to cause marked sympathetic activation;
(4) cases in which the presence or absence of PPGL could not be definitively determined due to insufficient pathological, imaging, or clinical follow-up data.
Target sample size
800
Research contact person
Name of lead principal investigator
| 1st name | Kazuhiro |
| Middle name | |
| Last name | Takekoshi |
Organization
University of Tsukuba
Division name
Laboratory of Laboratory/Sports Medicine, Institute of Medicine
Zip code
305-8575
Address
1-1-1 Tennodai, Tsukuba, Ibaraki 305-8577, Japan
TEL
029-853-3209
k-takemd@md.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | Masato |
| Middle name | |
| Last name | Yonamine |
Organization
University of Tsukuba
Division name
Laboratory of Laboratory/Sports Medicine, Institute of Medicine
Zip code
305-8575
Address
1-1-1 Tennodai, Tsukuba, Ibaraki 305-8577, Japan
TEL
029-853-3209
Homepage URL
yonamine.masato.fu@un.tsukuba.ac.jp
Sponsor or person
Institute
University of Tsukuba
Institute
Department
Personal name
Funding Source
Organization
University of Tsukuba
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
Clinical Research Review Board, University of Tsukuba
Address
2-1-1 Amakubo, Tsukuba, Ibaraki, Japan
Tel
029-853-3914
rinshokenkyu@un.tsukuba.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
公立昭和病院、横浜労災病院、国立国際医療研究センター病院、神戸大学医学部附属病院、筑波大学附属病院
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 02 | Month | 13 | 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
827
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
| 2023 | Year | 03 | Month | 27 | Day |
Date of IRB
| 2023 | Year | 04 | Month | 19 | Day |
Anticipated trial start date
| 2023 | Year | 04 | Month | 19 | Day |
Last follow-up date
| 2025 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2026 | Year | 02 | Month | 12 | Day |
Last modified on
| 2026 | Year | 02 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069382
