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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000032898
Receipt No. R000037503
Official scientific title of the study Uterine peristalsis evaluation on cine MR imaging in patients after radical trachelectomy
Date of disclosure of the study information 2018/06/08
Last modified on 2018/06/07

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Basic information
Official scientific title of the study Uterine peristalsis evaluation on cine MR imaging in patients after radical trachelectomy
Title of the study (Brief title) Uterine peristalsis evaluation on cine MR imaging in patients after radical trachelectomy
Region
Japan

Condition
Condition Cervical cancer
Classification by specialty
Obsterics and gynecology Radiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To observe uterine peristalsis after radical trachelectomy
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Presence of physiological uterine peristalsis
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 Diagnosis
Type of intervention
Device,equipment
Interventions/Control_1 perform cine MR imaging in patients after radical trachelectomy
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
16 years-old <=
Age-upper limit
46 years-old >=
Gender Female
Key inclusion criteria After radical trachelectomy
Key exclusion criteria recurrence
menopause
Target sample size 30

Research contact person
Name of lead principal investigator Natsuki Tsuji
Organization Tazuke Kofukai Foundation, Medical Research Institute, Kitano Hospital
Division name Department of Obstetrics and Gynecology
Address 2-4-20 Ohgimachi, Kita-ku, Osaka, JAPAN, 530-8480
TEL 06-6312-1221
Email n-tsuzi@kitano-hp.or.jp

Public contact
Name of contact person Natsuki Tsuji
Organization Tazuke Kofukai Foundation, Medical Research Institute, Kitano Hospital
Division name Department of Obstetrics and Gynecology
Address 2-4-20 Ohgimachi, Kita-ku, Osaka, JAPAN, 530-8480
TEL 06-6312-1221
Homepage URL
Email n-tsuzi@kitano-hp.or.jp

Sponsor
Institute Tazuke Kofukai Foundation, Medical Research Institute, Kitano Hospital
Institute
Department

Funding Source
Organization Tazuke Kofukai Foundation, Medical Research Institute, Kitano Hospital
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor Kyoto University Hospital
Japanese Red Cross Wakayama Medical Center
Name of secondary funder(s)

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
2018 Year 06 Month 08 Day

Progress
Recruitment status No longer recruiting
Date of protocol fixation
2014 Year 02 Month 28 Day
Anticipated trial start date
2014 Year 02 Month 28 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information

Management information
Registered date
2018 Year 06 Month 07 Day
Last modified on
2018 Year 06 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037503

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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