UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062472 |
|---|---|
| Receipt number | R000071501 |
| Scientific Title | A Clinical Study on the Omission of Lymph Node Dissection Based on Intraoperative Diagnosis of Sentinel Lymph Nodes in Uterine Cancer Surgery |
| Date of disclosure of the study information | 2026/08/06 |
| Last modified on | 2026/08/04 21:13:11 |
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Basic information
Public title
A Clinical Study on the Omission of Lymph Node Dissection Based on Intraoperative Diagnosis of Sentinel Lymph Nodes in Uterine Cancer Surgery
Acronym
A Clinical Study on the Omission of Lymph Node Dissection Based on Intraoperative Diagnosis of Sentinel Lymph Nodes in Uterine Cancer Surgery
Scientific Title
A Clinical Study on the Omission of Lymph Node Dissection Based on Intraoperative Diagnosis of Sentinel Lymph Nodes in Uterine Cancer Surgery
Scientific Title:Acronym
A Clinical Study on the Omission of Lymph Node Dissection Based on Intraoperative Diagnosis of Sentinel Lymph Nodes in Uterine Cancer Surgery
Region
| Japan |
Condition
Condition
endometrial cancer and cervical cancer
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the safety and efficacy of a reduced-scope surgical procedure that omits pelvic lymph node dissection through sentinel lymph node navigation surgery in early-stage uterine cancer
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Incidence of lymphedema within 2 years after surgery
Key secondary outcomes
Perioperative complications, ICG administration site and dose in the uterine body, recurrence rate, and prognosis
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
Diagnosis
Type of intervention
| Medicine |
Interventions/Control_1
Indocyanine green and Technecetinic acid
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
| Not applicable |
Gender
Female
Key inclusion criteria
1. Stage 1A or IB endometrial cancer (FIGO 2008) or Stage IA1, IA2, IB1, or IIA1 cervical cancer (FIGO 2018)
2. Patients with no enlarged lymph nodes detected on preoperative examination
3. Patients from whom written informed consent has been obtained
Key exclusion criteria
Patients with an unconfirmed diagnosis of uterine cancer
Patients with uterine sarcoma
Patients with hypersensitivity to 99mTc or ICG
Patients for whom participation in the study is considered difficult, such as those with psychosis or psychiatric symptoms
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Akemi |
| Middle name | |
| Last name | Morimoto |
Organization
Ehime University
Division name
Department of Obstetrics and Gynecology
Zip code
791-0295
Address
454 Shitsukawa, Toon city, Ehime
TEL
089-060-5379
morimoto.akemi.ag@ehime-u.ac.jp
Public contact
Name of contact person
| 1st name | Akemi |
| Middle name | |
| Last name | Morimoto |
Organization
Ehime University
Division name
Department of Obstetrics and Gynecology
Zip code
791-0295
Address
454 Shitsukawa, Toon city, Ehime
TEL
089-060-5379
Homepage URL
morimoto.akemi.ag@ehime-u.ac.jp
Sponsor or person
Institute
Ehime University
Institute
Department
Personal name
Funding Source
Organization
Department of Obstetrics and Gynecology, Ehime 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
Ehime University
Address
454 Shitsukawa, Toon city, Ehime
Tel
089-060-5379
morimoto.akemi.ag@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
| 2026 | Year | 08 | Month | 06 | 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
| 2026 | Year | 03 | Month | 04 | Day |
Date of IRB
| 2026 | Year | 03 | Month | 23 | Day |
Anticipated trial start date
| 2026 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2030 | 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
| 2026 | Year | 08 | Month | 04 | Day |
Last modified on
| 2026 | Year | 08 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071501
