UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020922 |
|---|---|
| Receipt number | R000024139 |
| Scientific Title | comparative study on microRNA in serum and cavernous tissue of patients with refractory erectile dysfunction and controls |
| Date of disclosure of the study information | 2016/02/08 |
| Last modified on | 2017/08/11 07:17:41 |
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Basic information
Public title
comparative study on microRNA in serum
and cavernous tissue of patients with refractory erectile dysfunction and controls
Acronym
level of microRNA in serum and cavernous tissue in patients with erectile dysfunction and controls
Scientific Title
comparative study on microRNA in serum
and cavernous tissue of patients with refractory erectile dysfunction and controls
Scientific Title:Acronym
level of microRNA in serum and cavernous tissue in patients with erectile dysfunction and controls
Region
| Africa |
Condition
Condition
erectile dysfunction
Classification by specialty
| Urology | Adult |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
study of role of microRNA in erectile dysfunction and its possible role as a marker of refractory erectile dysfunction.
Basic objectives2
Others
Basic objectives -Others
possible role micrRNA as a marker of refractory erectile dysfunction.
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
level of microRNA in serum and cavernous tissue in patients with refractory ED and
controls
Key secondary outcomes
potential role of microRNA as a diagnostic marker of refractory ED
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Diagnosis
Type of intervention
| Maneuver |
Interventions/Control_1
measurement of microRNA in serum and cavernous tissue in patients with refractory ED during penile implant insertion
Interventions/Control_2
measurement of microRNA in serum and cavernous tissue of controls
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
| 25 | years-old | <= |
Age-upper limit
| 60 | years-old | >= |
Gender
Male
Key inclusion criteria
patients suffer from refractory erectile
dysfunction. Controls are individuals known of excellent potency
Key exclusion criteria
patients suffer from erectile dysfunction (diabetics or cardiacs)
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | sameh fayek |
Organization
Cairo University
Division name
Andrology & STDs
Zip code
Address
Kasr Alaini street
TEL
+81-1227109309
samehfayek@hotmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | sameh fayek |
Organization
Cairo University
Division name
Andrology department
Zip code
Address
Kasr AlAini street
TEL
+81-1227109309
Homepage URL
http://scholar.cu.edu.eg/sfayek/
samehfayek@hotmail.com
Sponsor or person
Institute
no body
Institute
Department
Personal name
Funding Source
Organization
private resource
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
Kasr AlAini faculty of medicine Cairo University
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 02 | Month | 08 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Main result already published
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
Main results already published
Date of protocol fixation
| 2015 | Year | 05 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 05 | Month | 12 | Day |
Last follow-up date
| 2016 | Year | 02 | Month | 07 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 02 | Month | 08 | Day |
Last modified on
| 2017 | Year | 08 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024139
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
