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
About this trial
This is an interventional diagnostic trial for Endometrial Cancer
Eligibility Criteria
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
NCT ID
NCT02560571
First Posted
September 21, 2015
Last Updated
September 18, 2016
Sponsor
Meir Medical Center
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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