UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054870 |
|---|---|
| Receipt number | R000062667 |
| Scientific Title | Exploratory research for biomarkers relevant to the diagnosis and metastatic risk assessment of pheochromocytoma and paraganglioma |
| Date of disclosure of the study information | 2024/07/03 |
| Last modified on | 2024/07/03 17:44:50 |
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Basic information
Public title
Exploratory research for biomarkers relevant to the diagnosis and metastatic risk assessment of pheochromocytoma and paraganglioma
Acronym
Biomarker research for pheochromocytoma and paraganglioma
Scientific Title
Exploratory research for biomarkers relevant to the diagnosis and metastatic risk assessment of pheochromocytoma and paraganglioma
Scientific Title:Acronym
Exploratory research for biomarkers relevant to the diagnosis and metastatic risk assessment of pheochromocytoma and paraganglioma
Region
| Japan |
Condition
Condition
pheochromocytoma and paraganglioma
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
This study aims to develop novel biomarkers for early diagnosis, assessment of distant metastatic risk and prognostic prediction of pheochromocytoma and paraganglioma
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Correlation between blood and urine metabolites and clinical stage
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
| 16 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients with pheochromocytoma/paraganglioma (PPGL)
2) Carriers of pathological variants who are genetically at high risk of developing PPGL (PPGL-naive patients)
3) Patients with other adrenal tumours (e.g. adrenal adenoma, adrenocortical carcinoma, neuroblastoma) as a control group and healthy subjects.
Key exclusion criteria
1) Patients on treatment for active malignancies other than PPGL (but not excluding patients with hereditary syndromes coexisting with PPGL such as multiple endocrine neoplasia or von Hippel-Lindau disease)
2) Patients deemed inappropriate for inclusion in the study by the Principal Investigator/contributor
Target sample size
180
Research contact person
Name of lead principal investigator
| 1st name | kazushiro |
| Middle name | |
| Last name | takekoshi |
Organization
Faculty of Medicine, University of Tsukuba, Ibaraki, Japan
Division name
Division of Endocrine Metabolism and Diabetes Mellitus
Zip code
305-8577
Address
University of Tsukuba, 1-1-1 Tennodai, Tsukuba 305-8577, Ibaraki, Japan
TEL
0298533209
k-takemd@md.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | MASATO |
| Middle name | |
| Last name | YONAMINE |
Organization
Faculty of Medicine, University of Tsukuba, Ibaraki, Japan
Division name
Laboratory of Laboratory/Sports Medicine,
Zip code
305-8575
Address
University of Tsukuba, 1-1-1 Tennodai, Tsukuba 305-8577, Ibaraki, Japan
TEL
0298533209
Homepage URL
yonamine.masato.fu@u.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
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Department of Pediatric Surgery, Nagoya University Graduate School of Medicine
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tsukuba University Hospital Clinical Research Ethics Committee
Address
2-1-1, Amakubo, Tsukuba 305-8576, Japan
Tel
0298533914
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
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 07 | Month | 03 | 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
Open public recruiting
Date of protocol fixation
| 2024 | Year | 05 | Month | 16 | Day |
Date of IRB
| 2024 | Year | 05 | Month | 16 | Day |
Anticipated trial start date
| 2024 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2031 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Exploratory clinical trials (multi-center studies)
Management information
Registered date
| 2024 | Year | 07 | Month | 03 | Day |
Last modified on
| 2024 | Year | 07 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062667
