UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040629 |
|---|---|
| Receipt number | R000046370 |
| Scientific Title | Research on excretory and sexual function in patients with Marfan, Loeys-Dietz and Ehlers-Danlos syndromes |
| Date of disclosure of the study information | 2020/06/15 |
| Last modified on | 2020/12/01 18:04:02 |
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Basic information
Public title
Research on excretory and sexual function in patients with Marfan, Loeys-Dietz and Ehlers-Danlos syndromes
Acronym
MS/LDS/EDS excretory research
Scientific Title
Research on excretory and sexual function in patients with Marfan, Loeys-Dietz and Ehlers-Danlos syndromes
Scientific Title:Acronym
MS/LDS/EDS excretory research
Region
| Japan |
Condition
Condition
Marfan, Loeys-Dietz and Ehlers-Danlos syndromes
Classification by specialty
| Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We perform a field study on urinary function, defecation function, hormone function, and sexual function in patients with Marfan, LLoeys-Dietz and Ehlers-Danlos syndromes.
Basic objectives2
Others
Basic objectives -Others
Field study
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Urinary incontinence rate, irritable bowel syndrome rate
Key secondary outcomes
Prevalence of sexual dysfunction, menopause
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
patients with Marfan, Loeys-Dietz and Ehlers-Danlos syndromes
Key exclusion criteria
Non consent patient
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Kazuna |
| Middle name | |
| Last name | Matsuo |
Organization
Graduate School of Medicine, Nagoya University
Division name
Urology
Zip code
466-8550
Address
65, Tsurumai-cho, Showa-ku, Nagoya city, Aichi Pref.
TEL
+81-52-744-2985
matuo@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | Kazuna |
| Middle name | |
| Last name | Matsuo |
Organization
Graduate School of Medicine, Nagoya University
Division name
Urology
Zip code
466-8550
Address
65, Tsurumai-cho, Showa-ku, Nagoya city, Aichi Pref.
TEL
+81-52-744-2985
Homepage URL
matuo@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University
Institute
Department
Personal name
Funding Source
Organization
Nagoya University
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
Ethics Review Committee
Address
65, Tsurumai-cho, Showa-ku, Nagoya city, Aichi Pref.
Tel
+81-52-741-2111
ethics@med.nagoya-u.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
| 2020 | Year | 06 | Month | 15 | 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
| 2020 | Year | 06 | Month | 02 | Day |
Date of IRB
| 2020 | Year | 10 | Month | 02 | Day |
Anticipated trial start date
| 2020 | Year | 10 | Month | 05 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2021 | Year | 01 | Month | 31 | Day |
Date trial data considered complete
| 2021 | Year | 02 | Month | 28 | Day |
Date analysis concluded
| 2021 | Year | 06 | Month | 30 | Day |
Other
Other related information
Urination function, defecation function, hormone function, sexual function
Management information
Registered date
| 2020 | Year | 06 | Month | 02 | Day |
Last modified on
| 2020 | Year | 12 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046370
