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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-jRCT1030260079

Enrollment

196

Registered

2026-04-23

Start date

2026-04-23

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Early-stage cervical cancer and early-stage endometrial cancer

Interventions

None listed

Eligibility

Sex/Gender

Female

Inclusion 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

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.

Design outcomes

Primary

Measure	Time frame
Relapse-free survival (RFS)	—

Secondary

Measure	Time frame
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	—

Contacts

Public ContactAtsushi Fusegi

Cancer Institute Hospital of Japanese Foundation for Cancer Research

atsushi.fusegi@jfcr.or.jp+81-3-3520-0111

Outcome results