UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024483 |
|---|---|
| Receipt number | R000028162 |
| Scientific Title | Non randomized single-arm study of cervical partial resection and diathermy for CIN |
| Date of disclosure of the study information | 2016/11/01 |
| Last modified on | 2021/06/27 11:11:43 |
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Basic information
Public title
Non randomized single-arm study of cervical partial resection and diathermy for CIN
Acronym
diathermy for CIN
Scientific Title
Non randomized single-arm study of cervical partial resection and diathermy for CIN
Scientific Title:Acronym
diathermy for CIN
Region
| Japan |
Condition
Condition
CIN2/3
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
efficacy and safety of local treatment of uterine cervix
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
recurrence of the disease in 24 months
Key secondary outcomes
1.efficacy of HPV testing for reccurrence
2.monitoring adverse effects
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
| Device,equipment |
Interventions/Control_1
operation, once
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
| 50 | years-old | >= |
Gender
Female
Key inclusion criteria
1.patients obtained documents of fully informed consent
2.patients aged from 20 to 50.
3.diagnosed with CIN2/3
4.disease area is not occupied in whole cervix
5. PS 0 or 1
6.no past history of cone, vapolization or hysterectomy
Key exclusion criteria
1.impossible conservative observation due to severe complication
2.no active double cancer
3.psychic disorder
4.pregnant
5.inadequate condition judged by doctors
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | TAKUMA |
| Middle name | |
| Last name | FUJII |
Organization
Fujita Health University
Division name
Department of Obstetrics and Gynecology
Zip code
470-1192
Address
Kutsukakecho,Toyoake, Aichi
TEL
0562-93-2111
fujiit44@fujita-hu.ac.jp
Public contact
Name of contact person
| 1st name | TAKUMA |
| Middle name | |
| Last name | FUJII |
Organization
Fujita Health University
Division name
department of Obstetrics and Gynecology
Zip code
470-1192
Address
Kutsukakecho, Toyoake, Aichi
TEL
0562-93-9294
Homepage URL
fujiit44@fujita-hu.ac.jp
Sponsor or person
Institute
Fujita Health University
Institute
Department
Personal name
Funding Source
Organization
Fujita Health University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Fujita Health University
Address
1-98,Dengakugakubo,kutsukakecho,Toyoake,Aichi,Japan
Tel
0562-93-2111
fujiit44@gmail.com
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
藤田医科大学（愛知県）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 11 | Month | 01 | 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
No longer recruiting
Date of protocol fixation
| 2016 | Year | 10 | Month | 13 | Day |
Date of IRB
| 2016 | Year | 10 | Month | 13 | Day |
Anticipated trial start date
| 2016 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2021 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2021 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2022 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 10 | Month | 19 | Day |
Last modified on
| 2021 | Year | 06 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028162
