UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027001 |
|---|---|
| Receipt number | R000030959 |
| Scientific Title | Pathological finding of fallopian tube removed during cesarean section and gynecologic surgery |
| Date of disclosure of the study information | 2017/04/15 |
| Last modified on | 2019/10/17 08:55:29 |
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Basic information
Public title
Pathological finding of fallopian tube removed
during cesarean section and gynecologic surgery
Acronym
Pathological finding of fallopian tube removed
during cesarean section and gynecologic surgery
Scientific Title
Pathological finding of fallopian tube removed
during cesarean section and gynecologic surgery
Scientific Title:Acronym
Pathological finding of fallopian tube removed
during cesarean section and gynecologic surgery
Region
| Japan |
Condition
Condition
Tubal sterilization during cesarean section
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate pathological findings in fallopian tubes removed during cesarean section
Basic objectives2
Others
Basic objectives -Others
Pathological findings
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Precursors of ovarian carcinoma in fallopian tubes
Key secondary outcomes
Hormone receptors
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
1) Patients who undergo salpingectomy for tubal sterilizaion during cesarean section
or
2) Patients who undergo salpingectomy during surgery for benign gynecologic disease
Key exclusion criteria
1) Present condition or past history of gynecologic malignancy
2) Other conditions not suitable for this study
Target sample size
260
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Akira Kohyama |
Organization
Tokyo Metropolitan Tama Medical Center
Division name
Department of Obstetrics and Gynecology
Zip code
Address
2-8-29 Musashidai Fuchushi Tokyo, Japan
TEL
042-323-5111
Akira_kouyama@tmhp.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tsutomu Ida |
Organization
Tokyo Metropolitan Tama Medical Center
Division name
Department of Obstetrics and Gynecology
Zip code
Address
2-8-29 Musashidai Fuchushi Tokyo, Japan
TEL
042-323-5111
Homepage URL
t-ida@umin.ac.jp
Sponsor or person
Institute
Tokyo Metropolitan Tama Medical Center
Institute
Department
Personal name
Funding Source
Organization
Office of metropolitan hospital management
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Japan
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
東京都立多摩総合医療センター（東京都）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 04 | 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
Completed
Date of protocol fixation
| 2017 | Year | 03 | Month | 06 | Day |
Date of IRB
| 2017 | Year | 03 | Month | 06 | Day |
Anticipated trial start date
| 2017 | Year | 04 | Month | 15 | Day |
Last follow-up date
| 2019 | Year | 08 | Month | 14 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study is a prospective observational study to evaluate pathological findings in fallopian tubes removed during cesarean sections. We
especially evaluate precursors of ovarian carcinoma and hormone receptors. As a control, we also evaluate fallopian tubes removed during surgeries for benign gynecologic disease.
Management information
Registered date
| 2017 | Year | 04 | Month | 15 | Day |
Last modified on
| 2019 | Year | 10 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030959
