UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001767 |
|---|---|
| Receipt number | R000002124 |
| Scientific Title | Study to determine diagnostic value of plasma free metanephrine and normetanephrine for the diagnosis of pheochromocytomas. |
| Date of disclosure of the study information | 2009/04/01 |
| Last modified on | 2013/02/15 10:30:05 |
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Basic information
Public title
Study to determine
diagnostic value of plasma free metanephrine and normetanephrine for the diagnosis of pheochromocytomas.
Acronym
Diagnostic value of plasma free metanephrine and normetanephrine for the diagnosis of pheochromocytomas.
Scientific Title
Study to determine
diagnostic value of plasma free metanephrine and normetanephrine for the diagnosis of pheochromocytomas.
Scientific Title:Acronym
Diagnostic value of plasma free metanephrine and normetanephrine for the diagnosis of pheochromocytomas.
Region
| Japan |
Condition
Condition
pheochromocytomas
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To determine whether plasma free metanephrines could provide the best method for diagnosis of pheochromocytoma through comparing with plasma catecholamine, urinary catecholamine, urinary metanephrines and VMA.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
AUC: Area Under ROC Curve
Key secondary outcomes
1.sensitivity
2.specificity
3.Likelihood ratio of positive test
4.Likelihood ratio of negative test
5.Positive predictive value
6.Negative predictive value
7.Accuracy
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Patient who is going to admit hospital.
2. Patient who presented with clinical signs(eg, therapy resistant or paroxysmal hypertension), symptoms(eg, sweating, headache, palpitation) and the finding of adrenal mass, suggestive of pheochromocytoma. Based on these findings, he or she is determined to admit hospital to confirm this disease.
Also, patient who is determined to undergo surgery to confirm pheochromocytoma, since he or she has these suggestive signs, as described above.
3.Patients from whom informed consent was obtained
Key exclusion criteria
Inadequate to entry judged by investigators.
Target sample size
66
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuhiro Takekoshi |
Organization
Graduate School of Comprehensive Human Sciences
Division name
Molecular Clinical patholgy
Zip code
Address
1-1-1 Tennoudai, Tsukuba, 305-8575, Japan.
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazuhiro Takekoshi |
Organization
Graduate School of Comprehensive Human Sciences
Division name
Molecular Clinical patholgy
Zip code
Address
TEL
Homepage URL
http://www.md.tsukuba.ac.jp/clinical-med/lab-med/
Sponsor or person
Institute
Graduate School of Comprehensive Human Sciences
Molecular Clinical patholgy
Institute
Department
Personal name
Funding Source
Organization
None
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
Address
Tel
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
| 2009 | Year | 04 | Month | 01 | 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
Completed
Date of protocol fixation
| 2008 | Year | 12 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observational study for biochemical diagnosis of pheochromocytoma, comparing plasma free metanephrines with other various biochemical parameters.
Management information
Registered date
| 2009 | Year | 03 | Month | 11 | Day |
Last modified on
| 2013 | Year | 02 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002124
