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Assessing Uterine Ultrasound Done as a Diagnostic Tool for the Depth of Carcinoma Invasion

Primary Purpose

Endometrial Endometroid Carcinoma

Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Intraoperative ultrasound
Sponsored by
Carmel Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Endometrial Endometroid Carcinoma

Eligibility Criteria

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

Inclusion Criteria:

  1. Patient's age is 18 or above
  2. Patient has been scheduled to undergo hysterectomy (laparoscopic or abdominal) for the staging and treatment of endometrial cancer (endometrioid subtype) and with the relevant suspected symptoms.
  3. Patient able to understand,read and sign informed consent.
  4. Patient is not participating in other medical trials at present or in the past 30 days

Exclusion Criteria:

  1. Age under 18 years
  2. Patients assessed preoperatively to be at stage 2 and higher endometrial carcinoma

  3. Subjects which their biopsy in the pre operating process will include high risk cell types:

    • Grade 3 endometrioid adenocarcinoma,
    • clear cell carcinoma
    • papillary serous carcinoma
    • carcinosarcoma

Sites / Locations

  • Carmel Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Endometrial carcinoma patient

Arm Description

Outcomes

Primary Outcome Measures

Tumor invasion
Tumor invasion (in millimeters and in percentage of myometrial size) as assessed by ultrasound in comparison to macroscopic assesment during surgery and to final pathological report)

Secondary Outcome Measures

Full Information

First Posted
March 12, 2015
Last Updated
July 19, 2018
Sponsor
Carmel Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT02407535
Brief Title
Assessing Uterine Ultrasound Done as a Diagnostic Tool for the Depth of Carcinoma Invasion
Official Title
Assessing the Ultrasound Done on a the Uterus After Hysterectomy as a Diagnostic Tool for the Depth of Endometrial Carcinoma Invasion Into the Myometrium
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
March 2015 (undefined)
Primary Completion Date
June 1, 2018 (Actual)
Study Completion Date
June 1, 2018 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

5. Study Description

Brief Summary
In this study the investigators aim to assess the diagnostic performance of intraoperative, ultrasonographic assessment of the surgical extracted uterus for determining myometrial invasion's depth in comparison to preoperative ultrasound, intraoperative gross inspection and final pathological report (gold standard). The investigators hope that intraoperative gross inspection of the extracted uterus might offer an additional intraoperative tool for assessing the need for pelvic lymphadenectomy in early stage of endometrial cancer at least as good as pathological exam.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Endometrial carcinoma patient
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Intraoperative ultrasound
Intervention Description
Diagnostic intraoperative ultrasound in the uterus after hysterectomy for assessing depth of tumor invasion
Primary Outcome Measure Information:
Title
Tumor invasion
Description
Tumor invasion (in millimeters and in percentage of myometrial size) as assessed by ultrasound in comparison to macroscopic assesment during surgery and to final pathological report)
Time Frame
Average of 2 weeks (immediate assessment by ultrasound, average of 2 weeks for final pathological report)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patient's age is 18 or above Patient has been scheduled to undergo hysterectomy (laparoscopic or abdominal) for the staging and treatment of endometrial cancer (endometrioid subtype) and with the relevant suspected symptoms. Patient able to understand,read and sign informed consent. Patient is not participating in other medical trials at present or in the past 30 days Exclusion Criteria: Age under 18 years Patients assessed preoperatively to be at stage 2 and higher endometrial carcinoma Subjects which their biopsy in the pre operating process will include high risk cell types: Grade 3 endometrioid adenocarcinoma, clear cell carcinoma papillary serous carcinoma carcinosarcoma
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ido Feferkorn, MD
Organizational Affiliation
Carmel Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Carmel Medical Center
City
Haifa
Country
Israel

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Assessing Uterine Ultrasound Done as a Diagnostic Tool for the Depth of Carcinoma Invasion

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