UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014310 |
|---|---|
| Receipt number | R000016662 |
| Scientific Title | Prevalence of uterine sarcoma during myomectomy |
| Date of disclosure of the study information | 2014/06/30 |
| Last modified on | 2014/06/18 21:50:51 |
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Basic information
Public title
Prevalence of uterine sarcoma during myomectomy
Acronym
Prevalence of uterine sarcoma during myomectomy
Scientific Title
Prevalence of uterine sarcoma during myomectomy
Scientific Title:Acronym
Prevalence of uterine sarcoma during myomectomy
Region
| Europe |
Condition
Condition
Uterine leiomyomas are extremely common and frequently require surgery. A rare but potentially devastating consequence of myomectomy is inadvertent incomplete resection of a uterine sarcoma, resulting in tumor dissemination and a worse prognosis.
Classification by specialty
| Surgery in general | Obstetrics and Gynecology | Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
This study was to evaluate the incidence of uterine sarcomas during myomectomy
Basic objectives2
Others
Basic objectives -Others
Prevalence of disease
Trial characteristics_1
Others
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Prevalence of sarcomas in myomectomy and hysterectomy
Key secondary outcomes
Prevalence of sarcomas among removed fibroids
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
| 18 | years-old | < |
Age-upper limit
| 80 | years-old | > |
Gender
Female
Key inclusion criteria
All consecutive cases of myomectomy and hysterectomy performed over 10 years
Key exclusion criteria
Known malignanciy before surgery
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Marco Scioscia |
Organization
Sacro Cuore General Hospital
Division name
Obstetrics and Gynecology
Zip code
Address
Via Sempreboni 5, Negrar, Verona, Italy
TEL
+81-0393498724206
marcoscioscia@gmai.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Marco Scioscia |
Organization
Sacro Cuore Don Calabria
Division name
Obstetrics and Gynecology
Zip code
Address
Via Sempreboni 5, Negrar, Verona, Italy
TEL
+81-0393498724206
Homepage URL
marco.scioscia@sacrocuore.it
Sponsor or person
Institute
Sacroc Cuore General Hospital
Institute
Department
Personal name
Funding Source
Organization
Self Funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
None
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
Sacro Cuore General Hospital, Via Sempreboni 5, Negrar, Verona, Italy
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 06 | Month | 30 | 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
| 2014 | Year | 01 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 03 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The main aim of this study was to evaluate the prevalence of sarcomas among all myomectomies and hysterectomies carried out in our hospital over 10 years. Our hospital is a referral center for gynecological surgery.
Management information
Registered date
| 2014 | Year | 06 | Month | 18 | Day |
Last modified on
| 2014 | Year | 06 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016662
| Research Plan | |
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| 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 |
