UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049509 |
|---|---|
| Receipt number | R000056378 |
| Scientific Title | Clinical study to evaluate the efficacy and safety of laparoscopic and robot-assisted trachelectomy for stage I and IIA cervical cancer |
| Date of disclosure of the study information | 2022/11/15 |
| Last modified on | 2024/12/25 16:42:59 |
* 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
Clinical study to evaluate the efficacy and safety of laparoscopic and robot-assisted trachelectomy for stage I and IIA cervical cancer
Acronym
Clinical study to evaluate the efficacy and safety of laparoscopic and robot-assisted trachelectomy
Scientific Title
Clinical study to evaluate the efficacy and safety of laparoscopic and robot-assisted trachelectomy for stage I and IIA cervical cancer
Scientific Title:Acronym
Clinical study to evaluate the efficacy and safety of laparoscopic and robot-assisted trachelectomy
Region
| Japan |
Condition
Condition
cervical cancer
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To perform laparoscopic or robot-assisted hysterectomy for women with early-stage cervical cancer and desire for uterine preservation, to remove the tumor to preserve the uterine body and to maintain fertility, and to evaluate the usefulness and safety of this procedure.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
complication rate
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
2028/3/31
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
(1) Cervical cancer cases requiring radical surgery
(2) Cases in which radical resection is expected
(3) Cases in which the patient is between 20 and 45 years old at the time of surgery
(4) Cases in which uterus preservation is strongly desired
(5) Patients with PS(ECOG): 0 or 1
(6) Patients who have given written consent for this surgery
Key exclusion criteria
(1) Patients with distant metastasis to other organs or peritoneal dissemination
(2) Patients who have previously undergone intraperitoneal surgery for other diseases and are expected to have severe adhesions
(3) Other cases deemed inappropriate by the physician in charge
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Kota |
| Middle name | |
| Last name | Umemura |
Organization
Toyohashi Municipal Hospital
Division name
Gynecology
Zip code
441-8570
Address
50 nishi aza-hachiken Aotake Toyohashi, Aichi, Japan
TEL
0532336111
umemura-kota@toyohashi-mh.jp
Public contact
Name of contact person
| 1st name | Kota |
| Middle name | |
| Last name | Umemura |
Organization
Toyohashi Municipal Hospital
Division name
Gynecology
Zip code
441
Address
50 nishi aza-hachiken Aotake Toyohashi, Aichi, Japan
TEL
0532336111
Homepage URL
umemura-kota@toyohashi-mh.jp
Sponsor or person
Institute
Toyohashi Municipal Hospital
Institute
Department
Personal name
Funding Source
Organization
Toyohashi Municipal Hospital
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
Toyohashi Municipal Hospital
Address
50 nishi aza-hachiken Aotake Toyohashi, Aichi, Japan
Tel
0532336111
umemura-kota@toyohashi-mh.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
| 2022 | Year | 11 | Month | 15 | Day |
Related information
URL releasing protocol
https://www.municipal-hospital.toyohashi.aichi.jp/department/naishikyo_geka/
Publication of results
Unpublished
Result
URL related to results and publications
https://www.municipal-hospital.toyohashi.aichi.jp/department/naishikyo_geka/
Number of participants that the trial has enrolled
20
Results
Currently being performed
Results date posted
| 2024 | Year | 12 | Month | 25 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Patients with early-stage cervical cancer aged 20 to 45 years old
Participant flow
Those who wish to preserve their uterus and wish to become pregnant with early-stage cervical cancer
Adverse events
None in particular
Outcome measures
Operating time, amount of bleeding, complications, length of hospital stay
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2015 | Year | 10 | Month | 31 | Day |
Date of IRB
| 2015 | Year | 12 | Month | 21 | Day |
Anticipated trial start date
| 2016 | Year | 01 | Month | 12 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 11 | Month | 15 | Day |
Last modified on
| 2024 | Year | 12 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056378
