UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028666 |
|---|---|
| Receipt number | R000032818 |
| Scientific Title | Performance of laparoscopic radical hysterectomy for cervical cancer stage IA2, IB1, IIA1 |
| Date of disclosure of the study information | 2017/08/15 |
| Last modified on | 2018/08/16 09:39:18 |
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Basic information
Public title
Performance of laparoscopic radical hysterectomy for cervical cancer stage IA2, IB1, IIA1
Acronym
LRHStM
Scientific Title
Performance of laparoscopic radical hysterectomy for cervical cancer stage IA2, IB1, IIA1
Scientific Title:Acronym
LRHStM
Region
| Japan |
Condition
Condition
Cervical cancer stage IA2, IB1, IIA1
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of laparoscopic radical hysterectomy for cervical cancer stage IA2, IB1, IIA1
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Operative time, Estimated blood loss, Hospital stay, Recover to normal life, Complication
Key secondary outcomes
Histological finding, Pain score, QOL score
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 radical hysterectcomy
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 of recurrence
Good general status
Informed consent to attend the study
Key exclusion criteria
Hige and young age
Specimen can not retrieved outside
Positive lymph node metastasis and extracervical invasion
Double cancer
Target sample size
3
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Nao Suzuki |
Organization
St. Marianna School of Medicine
Division name
Obstetrics and Gynecology
Zip code
Address
2-16-1, Sugeo, Miyamae-Ku, Kawasaki city, Kanagawa prefecture
TEL
0449778111
nao@marianna-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Imari Deura |
Organization
St. Marianna School of Medicine
Division name
Obstetrics and Gynecology
Zip code
Address
2-16-1, Sugeo, Miyamae-Ku, Kawasaki city, Kanagawa prefecture
TEL
0449778111
Homepage URL
imari@marianna-u.ac.jp
Sponsor or person
Institute
Obstetrics and Gynecology, St. Marianna 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
None
Name of secondary funder(s)
None
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
| 2017 | Year | 08 | 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
Completed
Date of protocol fixation
| 2017 | Year | 05 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
| 2018 | Year | 07 | Month | 31 | Day |
Date trial data considered complete
| 2018 | Year | 07 | Month | 31 | Day |
Date analysis concluded
| 2018 | Year | 07 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 08 | Month | 15 | Day |
Last modified on
| 2018 | Year | 08 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032818
