Clinical trial · Observational
Sentinel Lymph Node Dissection (SLND) in Patients With Apparent Early Stage Endometrial Cancer
The Validity of Sentinel Lymph Node Dissection (SLND) in Patients With Apparent Early Stage Endometrial Cancer (EC)
- 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)
The investigators hypothesize that SLND (unlike lymphadenectomy) decreases complications such as hemorrhage, lower extremity lymphedema and lymphocyst formation while enhancing quality of life in EC patients with low risk for nodal involvement. The investigators also hypothesize that SLND is an effective method of staging these patients. Studies have shown that SLN mapping identifies positive lymph nodes in women with newly diagnosed EC and this prognostic information obtained from SLND could guide selection of adjuvant treatment and improve overall survival. Using SLND as an alternative to lymphadenectomy may also have additional medical and economic impacts, such as, decreasing prolonged hospitalization and associated costs by shortening overall surgery duration.
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 Cancer | Malignant Endometrial Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- SLND Patients
- description
- Patients scheduled to have their sentinel lymph nodes removed, as part of standard of care.
Primary outcomes (1)
- measure
- SLND Positivity Rate in Study Participants
- timeFrame
- Up to 6 years
- description
- The rate of SLND positivity rate overall and by risk group in patients with clinically apparent early-stage EC. EC patients will be classified as high or low risk group based on the modified Mayo Criteria (Mariani A 2008, Milam 2012).
Secondary outcomes (5)
- measure
- Rate of NPV and FNPV of the SLND Procedure in Study Participants Who Undergo Partial or Full Lymphadenectomy.
- timeFrame
- Up to 6 years
- description
- The rate of the negative predictive value (NPV) and its complement the false negative predictive value (FNPV) rate of the SLND procedure in the subset of patients who also undergo partial or full lymphadenectomy. Negative Predictive Value (NPV) will be calculated by dividing the number of true negatives by the total number of patients with a negative SLN (false negatives and true negatives. False Negative Predictive Value (FNPV) rate will be calculated as the number false negatives divided by all patients without nodal metastasis (the number of false negatives and true negatives). FNPV rate is also known as the False Omission Rate (FOR); FNPV is the complement of NPV.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients must have histologically and/or cytologically confirmed endometrial cancer. 2. Clinically apparent early stage endometrial cancer (i.e. disease confined to the uterus on preoperative work up). 3. Patient has already scheduled an SLND surgery with treating physician. 4. Females aged 18 years or older. 5. Ability to understand and willingness to sign a written informed consent document. Exclusion Criteria: 1. Patients with lymphadenopathy and/or evidence of metastases, either clinically palpable and/or on preoperative radiological imaging. 2. Any preoperative adjuvant therapy for endometrial cancer (e.g. prior pelvic/abdominal radiotherapy (RT), chemotherapy, or retroperitoneal surgery). 3. Patients may not be receiving any investigational agents. 4. Pregnant or breastfeeding patients. 5. Central Nervous System (CNS) restrictions (i.e. brain metastases). 6. Any uncontrolled, intercurrent illness including but not limited to concomitant cancer, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia. 7. Any serious medical or psychiatric illness/condition.
References
Publications (0)
Data not yet available