UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000061061 |
|---|---|
| Receipt number | R000069869 |
| Scientific Title | Evaluation of Sentinel Lymph Node Biopsy in Patients with Early-Stage Endometrial Cancer |
| Date of disclosure of the study information | 2026/04/01 |
| Last modified on | 2026/03/26 02:33:50 |
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Basic information
Public title
Evaluation of Sentinel Lymph Node Biopsy in Patients with Early-Stage Endometrial Cancer
Acronym
SLN Mapping in Early Endometrial Cancer
Scientific Title
Evaluation of Sentinel Lymph Node Biopsy in Patients with Early-Stage Endometrial Cancer
Scientific Title:Acronym
SLN Mapping in Early Endometrial Cancer
Region
| Japan |
Condition
Condition
Early-Stage Endometrial Cancer
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The primary objective of cancer treatment is to minimize recurrence and metastasis, yet modern oncology increasingly emphasizes function-preserving or reduced surgeries to mitigate postoperative functional loss and maintain quality of life (QOL). While systematic lymphadenectomy has been the standard for staging endometrial cancer to determine postoperative therapy, it is associated with significant complications such as lymphedema and lymphocele. In patients with Grade 1 or 2 Stage IA endometrioid carcinoma, the incidence of metastasis is remarkably low, although a certain risk remains if the tumor diameter exceeds 2 cm. Sentinel lymph node (SLN) biopsy, which identifies the first node(s) of potential spread, offers a minimally invasive alternative that is already standard for melanoma and breast cancer. Based on our institution's previous research in cervical cancer, which demonstrated high sensitivity, negative predictive value, and reduced complications, we aim to extend this approach to endometrial cancer. As SLN biopsy is recognized in international guidelines and is expected to be covered by Japanese public health insurance in the near future, this study aims to accumulate further data on its safety and utility while providing patients with access to this beneficial procedure prior to its formal insurance inclusion.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Sentinel Lymph Node (SLN) Detection Rate
Key secondary outcomes
Operating time, Incidence of adverse events, Disease-free survival (DFS), Overall survival (OS)
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 lymph node (SLN) identification is performed using a dual-tracer method combining the radioisotope (RI) technique with either the dye method or indocyanine green (ICG) fluorescence; notably, ICG standalone mapping is excluded from this protocol and would require a separate approved amendment. For the RI method, technetium-99m (99mTc) phytate (38-111 MBq) is injected pericervically on the day before surgery, followed by two sessions of lymphoscintigraphy to accurately localize the SLNs. Intraoperatively, either 1% Patent Blue or ICG (1.25 mg/mL) is injected into the cervix. SLNs are identified using a gamma probe for RI, visual inspection for dye, or an infrared camera for ICG. Based on our institution's previous data in cervical cancer demonstrating 100% sensitivity and negative predictive value, systematic lymphadenectomy is omitted if an SLN is successfully identified. However, if an SLN cannot be identified on one side, a systematic pelvic lymphadenectomy is performed on that respective side. Excised SLNs undergo detailed pathological evaluation via permanent sections cut at 2-mm intervals along the short axis, in accordance with international ultrastaging standards. While the SLN procedure is investigational, the primary radical surgery and any subsequent adjuvant therapy-administered upon the detection of metastasis-are conducted as standard of care.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
1. Diagnosis: Histologically confirmed endometrial cancer.
2. Histological Type and Grade: Preoperative endometrial biopsy showing endometrioid carcinoma, Grade 1 or Grade 2.
3. Clinical Stage and Tumor Size: Preoperative imaging (CT and MRI) indicating Stage IA (FIGO 2008) with an estimated tumor diameter of 2 cm or larger.
4. Age: 18 years of age or older at the time of providing informed consent.
5. Informed Consent: Provision of written informed consent by the patient to participate in the study.
Key exclusion criteria
1. Severe Comorbidities: Presence of severe complications, including but not limited to hepatic, renal, or cardiac disease, bone marrow suppression, or active infection.
2. Drug Hypersensitivity: A history of hypersensitivity or allergic reactions to any of the drugs or agents used in this study (e.g., technetium-99m, Patent Blue, or ICG).
3. Ineligibility as Determined by Investigators: Any other condition that the principal investigator or sub-investigator deems inappropriate for participation in the study.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Akihito |
| Middle name | |
| Last name | Horie |
Organization
Medical Research Institute Kitano Hospital, PIIF Tazuke-Kofukai
Division name
Obstetrics and Gynecology
Zip code
530-8480
Address
2-4-20 Ogimachi, Kita-ku, Osaka City, Osaka, Japan
TEL
06-6312-1221
akihito-horie@kitano-hp.or.jp
Public contact
Name of contact person
| 1st name | Akihito |
| Middle name | |
| Last name | Horie |
Organization
Medical Research Institute Kitano Hospital, PIIF Tazuke-Kofukai
Division name
Obstetrics and Gynecology
Zip code
530-8480
Address
2-4-20 Ogimachi, Kita-ku, Osaka City, Osaka, Japan
TEL
06-6312-1221
Homepage URL
https://www.kitano-hp.or.jp/kenkyu/clinical-research
akihito-horie@kitano-hp.or.jp
Sponsor or person
Institute
Medical Research Institute Kitano Hospital, PIIF Tazuke-Kofukai
Institute
Department
Personal name
Funding Source
Organization
This study received no specific grant from any funding agency in the public, commercial, or not-for-profit sectors.
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Medical Research Institute Kitano Hospital, PIIF Tazuke-Kofukai
Address
2-4-20 Ogimachi, Kita-ku, Osaka City, Osaka, Japan
Tel
06-6312-1221
rinshou@kitano-hp.or.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 | 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
Open public recruiting
Date of protocol fixation
| 2026 | Year | 02 | Month | 26 | Day |
Date of IRB
| 2026 | Year | 03 | Month | 24 | Day |
Anticipated trial start date
| 2026 | Year | 03 | Month | 24 | Day |
Last follow-up date
| 2036 | Year | 12 | 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 | 03 | Month | 26 | Day |
Last modified on
| 2026 | Year | 03 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069869
