UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045534 |
|---|---|
| Receipt number | R000051975 |
| Scientific Title | A Study of the Usefulness of Minimally Invasive Surgery Using Sentinel Lymph Node as an Index in Early Stage Uterine Cancer |
| Date of disclosure of the study information | 2021/09/21 |
| Last modified on | 2021/09/21 20:26:53 |
* 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
A Study of the Usefulness of Minimally Invasive Surgery Using Sentinel Lymph Node as an Index in Early Stage Uterine Cancer
Acronym
Sentinel Node Navigation Surgery in Early Stage Uterine Cancer
Scientific Title
A Study of the Usefulness of Minimally Invasive Surgery Using Sentinel Lymph Node as an Index in Early Stage Uterine Cancer
Scientific Title:Acronym
Sentinel Node Navigation Surgery in Early Stage Uterine Cancer
Region
| Japan |
Condition
Condition
Uterine cancer
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to validate the usefulness and safety of minimally invasive surgery for early-stage uterine cancer by identifying the extent of retroperitoneal lymph node dissection using indocyanine green and infrared camera, using tissue blood flow and sentinel lymph nodes as indicators.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Sentinel lymph node identification rate, sensitivity, specificity, negative predictive value, and accuracy
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
Sentinel Node Navigation 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
| 20 | years-old | <= |
Age-upper limit
| 85 | years-old | > |
Gender
Female
Key inclusion criteria
A. Cervical cancer
1. Clinical stage IA1
2. Clinical stage IA2
3. Clinical stage IB1 with a tumor size of 2 cm or less.
4. Clinical stage IIA1 with a tumor size of 2cm or less.
5. Histological diagnosis: squamous cell carcinoma or adenocarcinoma, adenosquamous cell carcinoma
B. Endometrial cancer
1. Clinically advanced stage IA
2. Histological diagnosis: endometrioid carcinoma G1 or G2
Key exclusion criteria
1. Patients who seem to have insufficient judgment
2. Patients with significant lymph node swelling on imaging examination
3. Patients with a history of iodine hypersensitivity
4. Patients with a history of hypersensitivity to ICG components
5. Patients with severe obesity
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | kazu |
| Middle name | |
| Last name | ueda |
Organization
International University of Health and Welfare, Mita Hospital
Division name
Department of Gynecologic Oncology
Zip code
108-8329
Address
1-4-3 Mita, Minato-ku, Tokyo
TEL
03-3451-8121
kazu@iuhw.ac.jp
Public contact
Name of contact person
| 1st name | kazu |
| Middle name | |
| Last name | ueda |
Organization
International University of Health and Welfare, Mita Hospital
Division name
Department of Gynecologic Oncology
Zip code
108-8329
Address
1-4-3 Mita, Minato-ku, Tokyo
TEL
03-3451-8121
Homepage URL
kazu@iuhw.ac.jp
Sponsor or person
Institute
International University of Health and Welfare
Institute
Department
Personal name
Funding Source
Organization
International University of Health and Welfare
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
International University of Health and Welfare, Mita Hospital
Address
1-4-3 Mita, Minato-ku, Tokyo
Tel
03-3451-8121
kazu@iuhw.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
| 2021 | Year | 09 | Month | 21 | 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
| 2021 | Year | 04 | Month | 23 | Day |
Date of IRB
| 2021 | Year | 05 | Month | 19 | Day |
Anticipated trial start date
| 2021 | Year | 08 | Month | 31 | Day |
Last follow-up date
| 2026 | 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
| 2021 | Year | 09 | Month | 21 | Day |
Last modified on
| 2021 | Year | 09 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051975
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
