Tokyo, Aug. 7 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062472) titled 'A Clinical Study on the Omission of Lymph Node Dissection Based on Intraoperative Diagnosis of Sentinel Lymph Nodes in Uterine Cancer Surgery' on Aug. 6.
Study Type:
Interventional
Study Design:
Basic Design - Single arm
Randomization - Non-randomized
Blinding - Open -no one is blinded
Control - Uncontrolled
Primary Sponsor:
Institute - Ehime University
Condition:
Condition - endometrial cancer and cervical cancer
Classification by malignancy - Malignancy
Genomic information - NO
Objective:
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
Intervention:
Interventions/Control_1 - Indocyanine green and Technecetinic acid
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 Size - 150
Recruitment Status:
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
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071501
Disclaimer: Curated by HT Syndication.
