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

Clalit Health Services

Status and phase: Unknown; Phase 2

Conditions: Endometrial Cancer

Treatments: Other: blood test; Device: ultrasound

Study type: Interventional

Funder types: Other

Identifiers

NCT02560571

0142-15-MMC

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Endometrial cancer patients
• Surgical candidates

Exclusion criteria

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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200 participants in 1 patient group

all patients

Experimental group

Description:

all study patients will undergo ultrasound and blood test

Treatment:

Device: ultrasound

Other: blood test