Pre-operative Studies for Prediction of Lymph Nodes Involvement in Endometrial Cancer Patients

Phase 2

• Conditions: Endometrial Cancer

• Registration Number: NCT02560571
• Lead Sponsor: Meir Medical Center

Brief Summary

The study evaluates pre-operative prediction of the risk for lymph nodes involvement in endometrial cancer patients. Patients will undergo ultrasound exam (bi and three dimensional) and biomarker test - Ca 125, in addition to routine physical and laboratory exams, before surgery.

The sonographic evaluation will include endometrial characteristics and myometrial invasion, pelvic findings and enlarged lymph nodes.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-09-21
• Study First Submitted QC: 2015-09-24
• Study First Posted: 2015-09-25
• Study Start: 2015-10
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-18
• Last Update Posted: 2016-09-20
• Primary Completion: 2020-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 200

Inclusion Criteria

• Endometrial cancer patients
• Surgical candidates

Exclusion Criteria

• Fertility preservation therapy
• Contraindication for surgery
• Stage 2 and higher

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
number of participants with positive nodes	4 weeks after surgery (4-6 weeks from enrollment)

Trial Locations

Locations (1)

Meir medical center; 🇮🇱 Kefar Saba, Israel