Back to resultsCytologic Analysis of Distention Media as a Screening Test for Endometrial Cancer
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 screening trial for Endometrial Cancer focused on measuring Endometrial cancer, Sonohysterography
Eligibility Criteria
Inclusion Criteria:
- Newly diagnosed early-stage endometrial cancer
Exclusion Criteria:
- Recurrent or persistent endometrial cancer
- Evidence of distant metastases
Sites / Locations
- University of Wisconsin
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
pre-surgical SHG
Outcomes
Primary Outcome Measures
Cytology results
Secondary Outcome Measures
Full Information
NCT ID
NCT00462969
First Posted
April 17, 2007
Last Updated
November 15, 2019
Sponsor
University of Wisconsin, Madison
Collaborators
American College of Obstetricians and Gynecologists, National Cancer Institute (NCI)
1. Study Identification
Unique Protocol Identification Number
NCT00462969
Brief Title
Cytologic Analysis of Distention Media as a Screening Test for Endometrial Cancer
Official Title
Cytologic Analysis of Distention Media as a Screening Test for Endometrial Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
January 2015
Overall Recruitment Status
Completed
Study Start Date
April 2007 (undefined)
Primary Completion Date
September 2010 (Actual)
Study Completion Date
September 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Wisconsin, Madison
Collaborators
American College of Obstetricians and Gynecologists, National Cancer Institute (NCI)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to learn fluid from sonohysterography can be used to diagnose endometrial cancer.
Detailed Description
Participants will have a sonohysterography (SHG) performed. Fluid will be collected after instillation of 5mls of saline and again after an adequate SHG is performed. A pathologist will review this fluid to see is cancer cells are present.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endometrial Cancer
Keywords
Endometrial cancer, Sonohysterography
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
pre-surgical SHG
Intervention Type
Procedure
Intervention Name(s)
Sonohysterography
Intervention Description
Sonohysterography
Primary Outcome Measure Information:
Title
Cytology results
Time Frame
At completion of enrollment
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Newly diagnosed early-stage endometrial cancer
Exclusion Criteria:
Recurrent or persistent endometrial cancer
Evidence of distant metastases
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
553792
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
23881100
Citation
Guralp O, Sheridan SM, Harter J, Hinshaw JL, Seo S, Hartenbach EM, Lindheim S, Stewart S, Kushner DM. A new diagnostic test for endometrial cancer?: Cytology analysis of sonohysterography distention media. Int J Gynecol Cancer. 2013 Sep;23(7):1252-7. doi: 10.1097/IGC.0b013e31829fe8f6.
Results Reference
result
Links:
URL
https://cancer.wisc.edu
Description
University of Wisconsin Carbone Cancer Center
Learn more about this trial
Cytologic Analysis of Distention Media as a Screening Test for Endometrial Cancer
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