UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026559 |
|---|---|
| Receipt number | R000017396 |
| Scientific Title | Investigation of the safety of the radical trachelectomy with cervical cancer patients |
| Date of disclosure of the study information | 2017/03/15 |
| Last modified on | 2019/03/18 11:26:02 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Investigation of the safety of the radical trachelectomy with cervical cancer patients
Acronym
Investigation of the safety of the radical trachelectomy with cervical cancer patients
Scientific Title
Investigation of the safety of the radical trachelectomy with cervical cancer patients
Scientific Title:Acronym
Investigation of the safety of the radical trachelectomy with cervical cancer patients
Region
| Japan |
Condition
Condition
cervical cancer
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
It is shown that the radical trachelectomy to preserve fertility is a safety surgery.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
complication
the rate of recurrence
prognosis
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
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
abdominal 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
| 20 | years-old | <= |
Age-upper limit
| 45 | years-old | >= |
Gender
Female
Key inclusion criteria
Age: 20-45
Cervical cancer FIGO Ia2 - Ib1
Key exclusion criteria
The patient who cannot get consent to this clinical study.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Masahide |
| Middle name | |
| Last name | Ohmichi |
Organization
Osaka medical university
Division name
Obstetrics gynecology
Zip code
5698686
Address
2-7 Daigakumachi Takatsuki Osaka Japan
TEL
072-683-1221
gyn078@poh.osaka-med.ac.jp
Public contact
Name of contact person
| 1st name | Hiroshi |
| Middle name | |
| Last name | Sasaki |
Organization
Osaka medical university
Division name
Obstetrics gynecology
Zip code
5698686
Address
2-7 Daigakumachi Takatsuki Osaka Japan
TEL
072-683-1221
Homepage URL
gyn078@osaka-med.ac.jp
Sponsor or person
Institute
Osaka medical university
Institute
Department
Personal name
Funding Source
Organization
Grants in aid for Scientific Research
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
Osaka Medical College
Address
2-7 Daigakumachi Takatsuki Osaka Japan
Tel
0726831221
gyn078@osaka-med.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
| 2017 | Year | 03 | Month | 15 | 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
Enrolling by invitation
Date of protocol fixation
| 2014 | Year | 08 | Month | 18 | Day |
Date of IRB
| 2014 | Year | 08 | Month | 18 | Day |
Anticipated trial start date
| 2014 | Year | 08 | Month | 18 | Day |
Last follow-up date
| 2020 | Year | 08 | Month | 18 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 03 | Month | 15 | Day |
Last modified on
| 2019 | Year | 03 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017396
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
