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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000026853
Receipt No. R000030816
Scientific Title A prospective study of fertility preservation surgery after neoadjuvant chemotherapy for early cervical cancer
Date of disclosure of the study information 2017/04/05
Last modified on 2017/04/04

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Basic information
Public title A prospective study of fertility preservation surgery after neoadjuvant chemotherapy for early cervical cancer
Acronym Fertility preservation surgery after neoadjuvant chemotherapy
Scientific Title A prospective study of fertility preservation surgery after neoadjuvant chemotherapy for early cervical cancer
Scientific Title:Acronym Fertility preservation surgery after neoadjuvant chemotherapy
Region
Japan

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

Objectives
Narrative objectives1 Validity of fertility preservation surgery
after neoajuvant chemotherapy for cervical cancer
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Safety of surgery
Key secondary outcomes Rate of pregnancy

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 neoadjuvant chemotherapy three cycle
fertility presevation surgery
radical trachelectomy
adjuvant chemotherapy three cycle
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
0 years-old <=
Age-upper limit
40 years-old >
Gender Female
Key inclusion criteria Cervical cancer SCC
FIGO Stage 1B1
above two cm under four cm
Key exclusion criteria Non SCC
distant metastasis LN swelling
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hitoshi Niikura
Organization Tohoku University Hospital
Division name Gynecology
Zip code
Address Seiryo machi aobaku sendai
TEL 022-717-7254
Email Niikura@med.tohoku.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hideki Tokunaga
Organization Tohoku University
Division name gynecology
Zip code
Address Seiryo machi aobaku sendai
TEL 0227177254
Homepage URL
Email tokunagahideki@med.tohoku.ac.jp

Sponsor
Institute Tohoku University Hospital
Institute
Department

Funding Source
Organization Tohoku University Hospital
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

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

Other administrative information
Date of disclosure of the study information
2017 Year 04 Month 05 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 Preinitiation
Date of protocol fixation
2017 Year 04 Month 04 Day
Date of IRB
Anticipated trial start date
2017 Year 06 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

Management information
Registered date
2017 Year 04 Month 04 Day
Last modified on
2017 Year 04 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030816

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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