UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024421 |
|---|---|
| Receipt number | R000028105 |
| Scientific Title | Safety and feasibility of total laparoscopic radical hysterectomy for patients with cervical cancer |
| Date of disclosure of the study information | 2016/10/15 |
| Last modified on | 2020/04/21 17:58:00 |
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Basic information
Public title
Safety and feasibility of total laparoscopic radical hysterectomy for patients with cervical cancer
Acronym
Safety and feasibility of total laparoscopic radical hysterectomy
Scientific Title
Safety and feasibility of total laparoscopic radical hysterectomy for patients with cervical cancer
Scientific Title:Acronym
Safety and feasibility of total laparoscopic radical hysterectomy
Region
| Japan |
Condition
Condition
cervical cancer
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate safety and feasibility of total laparoscopic radical hysterectomy for patients with cervical cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Pathological evaluation of curability with resected specimen and the 3-year relapse-free 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
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Laparoscopic raadical 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
| 75 | years-old | >= |
Gender
Female
Key inclusion criteria
1) an age of 20 - 75 years
2) the presence of histologically-proven cervical cancer
3) an International Federation of Gynecology and Obstetrics (FIGO) stage of IA2, IB1, or IIA1
4) Those with adequate organ function
5) Performance status (PS) from 0 to 2
6) Those who have given written informed consent
Key exclusion criteria
1) Patients who have recurrence of cervical cancer
2) Those with previous laparotomy (excluded with appendectomy, cesarean section and surgery for ovarian tumor) or previous radiotherapy of abdomen
3) Those with concomitant active malignancy
4) Those with serious complication
5) Those who are pregnant or suspected to be pregnant
6) Body Mass Index of 30 or greater
7) Those with diagnosis of uterine cervical myoma with ultrasound scanning
8) Patients participating other clinical studies within twelve months.
9) Those who are inadequate to be enrolled in the protocol study by the investigator
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | Toru |
| Middle name | |
| Last name | Fujioka |
Organization
Ehime University, Graduate School of Medicine
Division name
Department of Obstetrics and Gynecology
Zip code
791-0295
Address
Shitsukawa, Toon, Ehime 791-0295 Japan
TEL
089-960-5379
fujioka@m.ehime-u.ac.jp
Public contact
Name of contact person
| 1st name | Toru |
| Middle name | |
| Last name | Fujioka |
Organization
Ehime University, Graduate School of Medicine
Division name
Department of Obstetrics and Gynecology
Zip code
791-0295
Address
Shitsukawa, Toon, Ehime 791-0295 Japan
TEL
089-960-5379
Homepage URL
fujioka@m.ehime-u.ac.jp
Sponsor or person
Institute
Ehime University Hospital
Institute
Department
Personal name
Funding Source
Organization
Department of Obstetrics and Gynecology, Ehime University, Graduate School of Medicine
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
Institutional Review Board, Ehime University Hospital
Address
Shitsukawa, Toon, Ehime
Tel
089-960-5172
rinri@m.ehime-u.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
| 2016 | Year | 10 | 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
Open public recruiting
Date of protocol fixation
| 2016 | Year | 05 | Month | 09 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2018 | Year | 10 | Month | 22 | Day |
Date trial data considered complete
| 2018 | Year | 10 | Month | 22 | Day |
Date analysis concluded
| 2018 | Year | 10 | Month | 22 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 10 | Month | 15 | Day |
Last modified on
| 2020 | Year | 04 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028105
