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

Primary Purpose

Endometrial Cancer

Status
Unknown status
Phase
Phase 2
Locations
Israel
Study Type
Interventional
Intervention
ultrasound
blood test
Sponsored by
Meir Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Endometrial Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Endometrial cancer patients
  • Surgical candidates

Exclusion Criteria:

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

Sites / Locations

  • Meir medical centerRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

all patients

Arm Description

all study patients will undergo ultrasound and blood test

Outcomes

Primary Outcome Measures

number of participants with positive nodes

Secondary Outcome Measures

Full Information

First Posted
September 21, 2015
Last Updated
September 18, 2016
Sponsor
Meir Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT02560571
Brief Title
Pre-operative Studies for Prediction of Lymph Nodes Involvement in Endometrial Cancer Patients
Official Title
Preoperative Evaluation of Endometrial Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Unknown status
Study Start Date
October 2015 (undefined)
Primary Completion Date
October 2020 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Meir Medical Center

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endometrial Cancer

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
all patients
Arm Type
Experimental
Arm Description
all study patients will undergo ultrasound and blood test
Intervention Type
Device
Intervention Name(s)
ultrasound
Intervention Type
Other
Intervention Name(s)
blood test
Primary Outcome Measure Information:
Title
number of participants with positive nodes
Time Frame
4 weeks after surgery (4-6 weeks from enrollment)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Endometrial cancer patients Surgical candidates Exclusion Criteria: Fertility preservation therapy Contraindication for surgery Stage 2 and higher
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
yfat kadan, md
Phone
972-9-7471575
Email
yfat_ka@clalit.org.il
Facility Information:
Facility Name
Meir medical center
City
Kefar Saba
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yfat Kadan

12. IPD Sharing Statement

Learn more about this trial

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

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