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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001767
Receipt No. 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

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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
Email

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/
Email

Sponsor
Institute Graduate School of Comprehensive Human Sciences
Molecular Clinical patholgy
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002124

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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