Sentinel Lymph Node Dissection (SLND) in Patients With Apparent Early Stage Endometrial Cancer

Completed

Conditions studied: Endometrial Cancer

In brief

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.

Key facts

Study ID

NCT02834988

Run by

University of Miami

People needed

76

Starts

2016-07-28

Expected to finish

2020-02-10

Last updated by the study team

2020-03-12

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Patients must have histologically and/or cytologically confirmed endometrial cancer.
• Clinically apparent early stage endometrial cancer (i.e. disease confined to the uterus on preoperative work up).
• Patient has already scheduled an SLND surgery with treating physician.
• Females aged 18 years or older.
• Ability to understand and willingness to sign a written informed consent document.

You may not qualify if…

• Patients with lymphadenopathy and/or evidence of metastases, either clinically palpable and/or on preoperative radiological imaging.
• Any preoperative adjuvant therapy for endometrial cancer (e.g. prior pelvic/abdominal radiotherapy (RT), chemotherapy, or retroperitoneal surgery).
• Patients may not be receiving any investigational agents.
• Pregnant or breastfeeding patients.
• Central Nervous System (CNS) restrictions (i.e. brain metastases).
• 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.
• Any serious medical or psychiatric illness/condition.

Where it is running

• University of Miami — Miami, Florida, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.