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

Phase 2

• Conditions: Endometrial Cancer
• Interventions: Device: ultrasound; Other: blood test

• 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

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

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

Read More

Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
all patients	ultrasound	all study patients will undergo ultrasound and blood test
all patients	blood test	all study patients will undergo ultrasound and blood test

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