UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038866 |
|---|---|
| Receipt number | 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 17:12:44 |
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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
| Obstetrics 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
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
watarih@med.hokudai.ac.jp
Sponsor or person
Institute
Hokkaido University Graduate School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044323
