UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047784 |
|---|---|
| Receipt number | R000054477 |
| Scientific Title | Lessons Learned from Management of Five Patients of Persistent Mullerian Duct Syndrome: a Case Series |
| Date of disclosure of the study information | 2022/05/19 |
| Last modified on | 2022/05/18 02:44:02 |
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Basic information
Public title
Lessons Learned from Management of Five Patients of Persistent Mullerian Duct Syndrome: a Case Series
Acronym
Lessons Learned from Management of Five Patients of Persistent Mullerian Duct Syndrome: a Case Series
Scientific Title
Lessons Learned from Management of Five Patients of Persistent Mullerian Duct Syndrome: a Case Series
Scientific Title:Acronym
Lessons Learned from Management of Five Patients of Persistent Mullerian Duct Syndrome: a Case Series
Region
| Asia(except Japan) |
Condition
Condition
PMDS
Classification by specialty
| Surgery in general | Pediatrics |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To study PMDS
Basic objectives2
Others
Basic objectives -Others
To study PMDS and report cases and their management.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
PMDS must be treated by resection of Mullerian structures.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Resection of Mullerian structures
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
| 2 | years-old | < |
Age-upper limit
| 32 | years-old | >= |
Gender
Male
Key inclusion criteria
Patients with PMDS
Key exclusion criteria
Patients without PMDS
Target sample size
5
Research contact person
Name of lead principal investigator
| 1st name | Muhammad Umer |
| Middle name | |
| Last name | Mukhtar |
Organization
KEMU
Division name
KEMU
Zip code
54000
Address
KEMU
TEL
+923160416469
m.umermukhtar@kemu.edu.pk
Public contact
Name of contact person
| 1st name | Muhammad Umer |
| Middle name | |
| Last name | Mukhtar |
Organization
KEMU
Division name
KEMU
Zip code
54000
Address
KEMU
TEL
+923160416469
Homepage URL
m.umermukhtar@kemu.edu.pk
Sponsor or person
Institute
KEMU
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
NA
Address
NA
Tel
NA
NA
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
| 2022 | Year | 05 | Month | 19 | 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
5
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
| 2022 | Year | 04 | Month | 18 | Day |
Date of IRB
| 2022 | Year | 05 | Month | 13 | Day |
Anticipated trial start date
| 2022 | Year | 06 | Month | 20 | Day |
Last follow-up date
| 2022 | Year | 07 | Month | 19 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 05 | Month | 18 | Day |
Last modified on
| 2022 | Year | 05 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054477
| Research Plan | |
|---|---|
| Registered date | File name |
| 2023/06/01 | New Microsoft Word Document.docx |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| 2023/06/01 | New Microsoft Word Document.docx |
| Research case data | |
|---|---|
| Registered date | File name |
| 2023/06/01 | New Microsoft Word Document.docx |
Single case data URL
Value
https://center6.umin.ac.jp/ice/54477
