臨床研究等提出・公開システム

Date of registration	April. 23, 2026
Last modified on	April. 23, 2026
Trial ID	jRCT1030260079

Scientific Title	A single-center prospective observational study to evaluate the safety and efficacy of sentinel lymph node navigation surgery (SNNS) for uterine malignancies
Public Title	A single-center prospective observational study to evaluate the safety and efficacy of sentinel lymph node navigation surgery (SNNS) for uterine malignancies

Contact for Scientific Queries	Name	Kanao Hiroyuki
	Affiliation	Cancer Institute Hospital of Japanese Foundation for Cancer Research
	Address	3-8-31, Ariake, Koto, Tokyo
	Telephone	+81-3-3520-0111
	E-mail	hiroyuki.kanao@jfcr.or.jp
Contact for Public Queries	Name	Fusegi Atsushi
	Affiliation	Cancer Institute Hospital of Japanese Foundation for Cancer Research
	Address	3-8-31, Ariake, Koto, Tokyo
	Telephone	+81-3-3520-0111
	E-mail	atsushi.fusegi@jfcr.or.jp

Recruitment status	Pending

Anticipated date of first enrollment		April. 23, 2026
Target sample size		196
Study Type		Observational
Study Design	allocation	single arm study
	masking	open(masking not used)
	control	uncontrolled control
	assignment	single assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion Criteria	1. Clinically diagnosed with uterine cervical cancer or endometrial cancer. 2. Histologically confirmed diagnosis of the following: For cervical cancer: Squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma. For endometrial cancer: Endometrioid carcinoma, serous carcinoma, or clear cell carcinoma. 3. Clinical stage (per JSGO 2020 / FIGO 2018 for cervical cancer; JSGO 2011 / FIGO 2008 for endometrial cancer) meets the following: Cervical cancer: Stage IA1 (with lymphovascular space invasion), IA2, IB1, IB2, or IIA1. Endometrial cancer: Stage IA or IB. 4. Aged 18 to 79 years at the time of informed consent. 5. ECOG Performance Status (PS) of 0 or 1. 6. No prior treatment for uterine cervical cancer or endometrial cancer. 7. Provision of written informed consent. (For cases where SNNS was performed as routine clinical care before protocol approval, registration is permitted if written consent is obtained after approval.) 8. Patients undergoing fertility-sparing surgery for cervical cancer (e.g., conization, trachelectomy) are also eligible.
	Exclusion Criteria	1. Presence of active double cancer (synchronous multiple cancers/multicentric cancers or metachronous multiple cancers/multicentric cancers with a disease-free interval of less than 5 years; however, carcinoma in situ is excluded). 2. History of prior radiation therapy to the abdomen or pelvis. 3. Pregnant or possibly pregnant. 4. Deemed by the attending physician to have difficulty participating in the study for other clinical reasons. 5. Otherwise judged as ineligible by the principal investigator for any other reason.
	Age Minimum	18age old over
	Age Maximum	80age old not
	Gender	Female
Health Condition(s) or Problem(s) Studied		Early-stage cervical cancer and early-stage endometrial cancer
Primary Outcome(s)		Relapse-free survival (RFS)
Secondary Outcome(s)		1. Overall survival (OS) 2. Details of sentinel lymph nodes (Identification rate, anatomical location, and number of nodes detected) 3. Incidence of perioperative complications associated with SNNS

Primary Sponsor	None

Name of Certified Review Board	None
Address	None, Tokyo, Tokyo
Telephone	+81-3-3520-0111
E-Mail	atsushi.fusegi@jfcr.or.jp
Approval Status	Not approval
Date of approval	April. 06, 2026

Plan to share IPD	No

Countries of Recruitment（Except Japan）	None