Clinical trial · Interventional
Sentinel Lymph Node Mapping In Endometrial Cancer
Comparing the Diagnostic Value of Different Lymph Node Tracing Methods in Detecting Sentinel Lymph Node Metastasis in Endometrial Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Lymph node assessment provides the crucial information about the prognosis of endometrial cancer. Sentinel lymph node stands in the first station on the lymph node metastasis pathways. While traditional systemically lymph node resection would bring a lot of complications, sentinel node mapping and biopsy is a feasible way with less damage to evaluate whether lymph node metastasis occurs in endometrial cancer patients, due to less lymph nodes resected. However, the process of this technology in endometrial cancer isn't well established. The investigators intend to conduct a prospective and multicentric study to evaluate the effectiveness of different mapping methods to achieve a reliable lymph node assessment. Endometrial cancer patients in each center will be recruited in the investigators' study with inclusion and exclusion criteria. After the patients signing the informed consent form, the surgery process will be performed, including sentinel lymph node mapping with Carbon Nanoparticles (CNP) or CNP combining Indocyanine Green(ICG), hysterectomy with or without bilateral adnexectomy, pelvic and para-aortic lymph node resection, sequentially. All resected nodes will be pathologically exanimated. Then the data obtained will be analyzed and discussed deeply and finally lead to a conclusion.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Endometrial Neoplasms | Endometrial Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Sentinel Lymph Node Biopsy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Undergoing sentinel lymph node biopsy
- interventionNames
- Procedure: Sentinel Lymph Node Biopsy
Primary outcomes (1)
- measure
- Negative predictive value
- timeFrame
- Through study completion, an average of 2 years
- description
- Sentinel lymph node detection is defined as at least one lymph node is found in a patient. Sentinel lymph node negative is defined as no sentinel lymph node detected. True negative is defined as no metastasis found in both sentinel lymph nodes (SLNs) and non-SLNs. Negative predictive value is defined as the proportion of true negative patients to SLNs negative patients in patients with sentinel lymph nodes detected, which means patients without SLNs detected won't be included in the calculation.
Secondary outcomes (3)
- measure
- detection rate
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Diagnosis of endometrial cancer (including all pathological type and clinical stage). * Decide to receive hysterectomy with or without bilateral adnexectomy, pelvic and para-aortic lymph node resection * Agree to conduct the study and sign an informed consent form Exclusion Criteria: * History of previous pelvic or inguinal lymphadenectomy or other history of surgery affecting the uterine lymphatic drainage * Other history of pelvic or abdominal malignant tumors in the past 5 years * Intolerable for surgery due to severe comorbidities * During a period of pregnancy * Allergic to the tracer * Diagnosis of uncontrolled epilepsy, central nervous system disease or mental disorder, with the judgment from the investigator that the above diseases would affect clinical research compliance.
References
Publications (10)
- BACKGROUNDFerlay J, Soerjomataram I, Dikshit R, Eser S, Mathers C, Rebelo M, Parkin DM, Forman D, Bray F. Cancer incidence and mortality worldwide: sources, methods and major patterns in GLOBOCAN 2012. Int J Cancer. 2015 Mar 1;136(5):E359-86. doi: 10.1002/ijc.29210. Epub 2014 Oct 9. PMID 25220842
- BACKGROUNDCreasman WT, Morrow CP, Bundy BN, Homesley HD, Graham JE, Heller PB. Surgical pathologic spread patterns of endometrial cancer. A Gynecologic Oncology Group Study. Cancer. 1987 Oct 15;60(8 Suppl):2035-41. doi: 10.1002/1097-0142(19901015)60:8+3.0.co;2-8. PMID 3652025
- BACKGROUNDMay K, Bryant A, Dickinson HO, Kehoe S, Morrison J. Lymphadenectomy for the management of endometrial cancer. Cochrane Database Syst Rev. 2010 Jan 20;(1):CD007585. doi: 10.1002/14651858.CD007585.pub2. PMID 20091639
- BACKGROUNDBenedetti Panici P, Basile S, Maneschi F, Alberto Lissoni A, Signorelli M, Scambia G, Angioli R, Tateo S, Mangili G, Katsaros D, Garozzo G, Campagnutta E, Donadello N, Greggi S, Melpignano M, Raspagliesi F, Ragni N, Cormio G, Grassi R, Franchi M, Giannarelli D, Fossati R, Torri V, Amoroso M, Croce C, Mangioni C. Systematic pelvic lymphadenectomy vs. no lymphadenectomy in early-stage endometrial carcinoma: randomized clinical trial. J Natl Cancer Inst. 2008 Dec 3;100(23):1707-16. doi: 10.1093/jnci/djn397. Epub 2008 Nov 25. PMID 19033573
- BACKGROUNDASTEC study group; Kitchener H, Swart AM, Qian Q, Amos C, Parmar MK. Efficacy of systematic pelvic lymphadenectomy in endometrial cancer (MRC ASTEC trial): a randomised study. Lancet. 2009 Jan 10;373(9658):125-36. doi: 10.1016/S0140-6736(08)61766-3. Epub 2008 Dec 16. PMID 19070889
- BACKGROUNDTodo Y, Kato H, Kaneuchi M, Watari H, Takeda M, Sakuragi N. Survival effect of para-aortic lymphadenectomy in endometrial cancer (SEPAL study): a retrospective cohort analysis. Lancet. 2010 Apr 3;375(9721):1165-72. doi: 10.1016/S0140-6736(09)62002-X. Epub 2010 Feb 24.