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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000038866
Receipt No. R000044323
Scientific Title Nerve-sparing radical hysterectomy and local control of cervical cancer
Date of disclosure of the study information 2019/12/12
Last modified on 2019/12/12

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Basic information
Public title Nerve-sparing radical hysterectomy and local control of cervical cancer
Acronym Nerve-sparing radical hysterectomy and cervical cancer
Scientific Title Nerve-sparing radical hysterectomy and local control of cervical cancer
Scientific Title:Acronym Nerve-sparing radical hysterectomy and cervical cancer
Region
Japan

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

Objectives
Narrative objectives1 To elucidate the patterns of recurrence and associated risk factors after nerve-sparing radical hysterectomy for cervical cancer
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes patterns of recurrence, local control rate, disease-free survival
Key secondary outcomes overall survival

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
75 years-old >=
Gender Female
Key inclusion criteria 1. stage IB1-IIB cervical cancer
2. patients who gave informed consent to undergoing radical hysterectomy
3. patients who did not deny participating in the study
Key exclusion criteria patients whom the principal investigator judged inappropriate for inclusion in the study
Target sample size 121

Research contact person
Name of lead principal investigator
1st name Hidemichi
Middle name
Last name Watari
Organization Hokkaido University
Division name Department of Obstetrics and Gynecology, Graduate School of Medicine
Zip code 060-8638
Address N15, W7, Kitaku, Sapporo
TEL 011-706-5938
Email watarih@med.hokudai.ac.jp

Public contact
Name of contact person
1st name Hidemichi
Middle name
Last name Watari
Organization Hokkaido University
Division name Department of Obstetrics and Gynecology, Graduate School of Medicine
Zip code 060-8638
Address N15, W7, Kitaku, Sapporo
TEL 011-706-5938
Homepage URL
Email watarih@med.hokudai.ac.jp

Sponsor
Institute Hokkaido University Graduate School of Medicine
Institute
Department

Funding Source
Organization None
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 Hokkaido University
Address N15, W7, Kitaku, Sapporo
Tel 011-706-5938
Email watarih@med.hokudai.ac.jp

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
2019 Year 12 Month 12 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 121
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
2019 Year 05 Month 08 Day
Date of IRB
2019 Year 07 Month 31 Day
Anticipated trial start date
2019 Year 07 Month 31 Day
Last follow-up date
2019 Year 08 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information A total of 121 consecutive patients with 2008 FIGO stage IB1-IIB cervical cancer treated with nerve-sparing Okabayashi-Kobayashi radical hysterectomy between 2002 and 2011 were included in the study. Local control rate, overall survival and disease-free survival were investigated.

Management information
Registered date
2019 Year 12 Month 12 Day
Last modified on
2019 Year 12 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044323

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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