UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025318 |
|---|---|
| Receipt number | R000029122 |
| Scientific Title | Laparoscopic radical hysterectomy for stage IA2, IB1, IIA1 cervical cancer (advanced medical treatment A-36) |
| Date of disclosure of the study information | 2016/12/18 |
| Last modified on | 2017/06/29 16:42:04 |
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Basic information
Public title
Laparoscopic radical hysterectomy for stage IA2, IB1, IIA1 cervical cancer (advanced medical treatment A-36)
Acronym
LRH-A36
Scientific Title
Laparoscopic radical hysterectomy for stage IA2, IB1, IIA1 cervical cancer (advanced medical treatment A-36)
Scientific Title:Acronym
LRH-A36
Region
| Japan |
Condition
Condition
Stage IA2, IB1, IIA1 cervical cancer
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of laparoscopic radical hysterectomy
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Disease free survival and overall survival
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
Laparoscopic radiccal hysterectomy
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
| 70 | years-old | > |
Gender
Female
Key inclusion criteria
Low risk group
Good general condition
Offical document with informed consent
Key exclusion criteria
A specimen can't be retrieved outside
Adjuvant treatment is necessary
Severe cimplication
Another cancer treated
A judgement of the doctor in charge
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Imari Deura |
Organization
Tottori university hospital
Division name
Obsterrics and gynecology
Zip code
Address
Nishi-cho 36-1, Yoago, Tottori
TEL
0859-38-6647
imari@med.tottori-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Imari Deura |
Organization
Tottori university hospital
Division name
Obsterrics and gynecology
Zip code
Address
Nishi-cho 36-1, Yoago, Tottori
TEL
0859-38-6647
Homepage URL
imari@med.tottori-u.ac.jp
Sponsor or person
Institute
Tottori university hospital
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
Address
Tel
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
| 2016 | Year | 12 | Month | 18 | 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
Terminated
Date of protocol fixation
| 2016 | Year | 05 | Month | 09 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 05 | Month | 09 | Day |
Last follow-up date
| 2017 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
| 2017 | Year | 04 | Month | 30 | Day |
Date trial data considered complete
| 2017 | Year | 04 | Month | 30 | Day |
Date analysis concluded
| 2017 | Year | 04 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 12 | Month | 18 | Day |
Last modified on
| 2017 | Year | 06 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029122
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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