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

NCT02834988 | Completed DMC

• 1 other identifier: 20151012
• Study Type: observational
• Target: 76
• Locations: 1 country
• Sites: 1

Brief Summary

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

Endometrial Cancer

Keywords

Endometrial Cancer; Sentinel Lymph Node Dissection; SLND

Outcome Measures

Primary Outcomes (1)

• SLND Positivity Rate in Study Participants

  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).

  Up to 6 years

Secondary Outcomes (5)

• Rate of NPV and FNPV of the SLND Procedure in Study Participants Who Undergo Partial or Full Lymphadenectomy.

  Up to 6 years

• Proportion of Types of Lymph Node Metastases Described by SLND in Study Participants

  Up to 6 years

• Comparison of Nodal Positivity Rates and the Pathologic Protocol for Sentinel Lymph Node Biopsies.

  Up to 6 years

• Rate of Progression-Free Survival in Study Participants With Nodal Metastasis

  Up to 6 years

• Rate of Overall Survival in Study Participants With Nodal Metastasis

  Up to 6 years

Study Arms (1)

SLND Patients

Patients scheduled to have their sentinel lymph nodes removed, as part of standard of care.

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Due to the nature of the disease under investigation, only women are eligible to participate in this trial. Women of all races and ethnicities may participate in this research study.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All of the patients enrolled on this trial are those who were scheduled to have their sentinel lymph nodes (SLN) removed standard of care.

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.

Sponsors & Collaborators

• University of Miami: lead

Study Sites (1)

University of Miami

Miami, Florida, 33136, United States

Location

MeSH Terms

Conditions

Endometrial Neoplasms

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Brian Slomovitz, MD

  University of Miami

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 13, 2016
• First Posted: July 15, 2016
• Study Start: July 28, 2016
• Primary Completion: January 14, 2020
• Study Completion: February 10, 2020
• Last Updated: March 12, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)