Back to resultsDisseminated Endometrial Cancer Cells During Sonohysterography
Primary Purpose
Endometrial Cancer
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Sonohysterography
Sponsored by
About this trial
This is an interventional other trial for Endometrial Cancer
Eligibility Criteria
Inclusion Criteria: Stage I endometrial Cancer Disease State IIA endometrial Cancer Disease Exclusion Criteria: Prior tubal ligation Prior bilateral salpingectomy
Sites / Locations
- University of Wisconsin
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
A
Arm Description
Outcomes
Primary Outcome Measures
determine the critical volume necessary to overcome tubal pressure and result in fluid dissemination during SHG
Secondary Outcome Measures
evaluate the functional viability of any disseminated tumor cells collected during SHG
Full Information
NCT ID
NCT00205023
First Posted
September 13, 2005
Last Updated
November 15, 2019
Sponsor
University of Wisconsin, Madison
1. Study Identification
Unique Protocol Identification Number
NCT00205023
Brief Title
Disseminated Endometrial Cancer Cells During Sonohysterography
Official Title
The Incidence of Disseminated Endometrial Cancer Cells During Sonohysterography and Their Functional Viability: a Prospective Study
Study Type
Interventional
2. Study Status
Record Verification Date
June 2008
Overall Recruitment Status
Completed
Study Start Date
January 2004 (undefined)
Primary Completion Date
February 2006 (Actual)
Study Completion Date
August 2006 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Wisconsin, Madison
4. Oversight
5. Study Description
Brief Summary
The purpose of study is to: 1) determine critical volume necessary to overcome tubal pressure and result in fluid dissemination and 2) evaluate functional viability of any disseminated tumor cells collected during SHG
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
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Sonohysterography
Intervention Description
SHG during surgery for endometrial cancer.
Primary Outcome Measure Information:
Title
determine the critical volume necessary to overcome tubal pressure and result in fluid dissemination during SHG
Time Frame
during surgery
Secondary Outcome Measure Information:
Title
evaluate the functional viability of any disseminated tumor cells collected during SHG
Time Frame
during surgery
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Stage I endometrial Cancer Disease
State IIA endometrial Cancer Disease
Exclusion Criteria:
Prior tubal ligation
Prior bilateral salpingectomy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David M Kushner, MD
Organizational Affiliation
University of Wisconsin, Madison
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Wisconsin
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States
12. IPD Sharing Statement
Links:
URL
https://cancer.wisc.edu
Description
University of Wisconsin Carbone Cancer Center
Learn more about this trial
Disseminated Endometrial Cancer Cells During Sonohysterography
We'll reach out to this number within 24 hrs