UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016927 |
|---|---|
| Receipt number | R000019648 |
| Scientific Title | A clinical trial of laparoscopic radical trachelectomy for cervical cancer stage I |
| Date of disclosure of the study information | 2015/04/01 |
| Last modified on | 2024/04/17 10:29:27 |
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Basic information
Public title
A clinical trial of laparoscopic radical trachelectomy for cervical cancer stage I
Acronym
A clinical trial of laparoscopic radical trachelectomy for cervical cancer stage I
Scientific Title
A clinical trial of laparoscopic radical trachelectomy for cervical cancer stage I
Scientific Title:Acronym
A clinical trial of laparoscopic radical trachelectomy for cervical cancer stage I
Region
| Japan |
Condition
Condition
Cervical cancer
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the feasibility, safety and oncological outcome of the laparoscopic surgery
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Evaluation of safety by intra-postoperative complication compared with the laparotomy
Key secondary outcomes
Evaluation of resected specimen
Disease free survival
3,5yr survival
operation time
blood loss
transfusion rate
intra-postoperative complication
post operative quality of life compared with the laparotomy
pregnancy rate
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
surgery
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
cervical cancer stage I
Key exclusion criteria
1) rare histological type or poor prognosis histological type
2) severe comorbidity
3) performance status 3.4
4) patients judged inappropriate for this study by the physician
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Eiji Kobayashi |
Organization
Osaka university
Division name
Obstetrics and Gynecology
Zip code
Address
2-2 Yamadaoka, Suita Osaka 565-0871
TEL
06-6879-3351
osakalapcx-adm@umin.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Eiji Kobayashi |
Organization
Osaka university
Division name
Obstetrics and Gynecology
Zip code
Address
2-2 Yamadaoka, Suita Osaka 565-0871
TEL
06-6879-3351
Homepage URL
osakalapcx-adm@umin.ac.jp
Sponsor or person
Institute
Osaka university
Institute
Department
Personal name
Funding Source
Organization
Osaka university
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
| 2015 | Year | 04 | 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
Completed
Date of protocol fixation
| 2015 | Year | 03 | Month | 16 | Day |
Date of IRB
| 2015 | Year | 03 | Month | 17 | Day |
Anticipated trial start date
| 2015 | Year | 03 | Month | 26 | Day |
Last follow-up date
| 2024 | Year | 02 | Month | 26 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 03 | Month | 26 | Day |
Last modified on
| 2024 | Year | 04 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019648
