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UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000027001
Receipt No. 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 2018/04/16

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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
Obsterics 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
Email 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
Email t-ida@umin.ac.jp

Sponsor
Institute Tokyo Metropolitan Tama Medical Center
Institute
Department

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
Email

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 Enrolling by invitation
Date of protocol fixation
2017 Year 03 Month 06 Day
Date of IRB
Anticipated trial start date
2017 Year 04 Month 15 Day
Last follow-up date
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
2018 Year 04 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030959

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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