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

NCT ID: NCT02560571

Last Updated: 2016-09-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-31

Brief Summary

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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

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Conditions

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Endometrial Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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all patients

all study patients will undergo ultrasound and blood test

Group Type EXPERIMENTAL

ultrasound

Intervention Type DEVICE

blood test

Intervention Type OTHER

Interventions

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ultrasound

Intervention Type DEVICE

blood test

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Endometrial cancer patients
* Surgical candidates

Exclusion Criteria

* Fertility preservation therapy
* Contraindication for surgery
* Stage 2 and higher
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Meir Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Yfat kadan

Dr

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Meir medical center

Kfar Saba, , Israel

Site Status RECRUITING

Countries

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Israel

Central Contacts

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yfat kadan, md

Role: CONTACT

972-9-7471575

Facility Contacts

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Yfat Kadan

Role: primary

Other Identifiers

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0142-15-MMC

Identifier Type: -

Identifier Source: org_study_id

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