UMIN-CTR Clinical Trial

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
Email	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
Email	m.umermukhtar@kemu.edu.pk

Sponsor
Institute	KEMU
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	NA
Address	NA
Tel	NA
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054477

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

Contact us.