Cytologic Analysis of Distention Media as a Screening Test for Endometrial Cancer

This study is currently recruiting participants.

Verified by University of Wisconsin, Madison, July 2008

Sponsors and Collaborators:	University of Wisconsin, Madison American College of Obstetricians and Gynecologists
Information provided by:	University of Wisconsin, Madison
ClinicalTrials.gov Identifier:	NCT00462969

Purpose

The purpose of this study is to learn fluid from sonohysterography can be used to diagnose endometrial cancer.

Condition	Intervention
Endometrial Cancer	Procedure: Sonohysterography

MedlinePlus related topics: Cancer

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Diagnostic, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Official Title:	Cytologic Analysis of Distention Media as a Screening Test for Endometrial Cancer

Further study details as provided by University of Wisconsin, Madison:

Primary Outcome Measures:

Cytology results [ Time Frame: At completion of enrollment ] [ Designated as safety issue: No ]

Estimated Enrollment:	30
Study Start Date:	April 2007
Estimated Study Completion Date:	April 2010
Estimated Primary Completion Date:	April 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental pre-surgical SHG	Procedure: Sonohysterography Sonohysterography

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Newly diagnosed early-stage endometrial cancer

Exclusion Criteria:

Recurrent or persistent endometrial cancer
Evidence of distant metastases

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00462969

Contacts

Contact: Cancer Connect	800-622-8922	uwccc@uwccc.wisc.edu
Contact: Sarah L. Stewart	608-263-0796	slstewart@wisc.edu

Locations

United States, Wisconsin
University of Wisconsin	Recruiting
Madison, Wisconsin, United States, 553792
Principal Investigator: David M. Kushner, MD

Sponsors and Collaborators

University of Wisconsin, Madison

American College of Obstetricians and Gynecologists

Investigators

Principal Investigator:

David M Kushner, MD

University of Wisconsin, Madison

More Information

Responsible Party:	University of Wisconsin ( David M. Kushner, MD )
Study ID Numbers:	CC 06701, H-2006-0333
Study First Received:	April 17, 2007
Last Updated:	July 17, 2008
ClinicalTrials.gov Identifier:	NCT00462969
Health Authority:	United States: Federal Government; United States: Institutional Review Board

Keywords provided by University of Wisconsin, Madison:

Endometrial cancer
Sonohysterography

Study placed in the following topic categories:

Genital Diseases, Female
Endometrial Neoplasms
Dilatation, Pathologic
Genital Neoplasms, Female

Uterine Diseases
Uterine Neoplasms
Urogenital Neoplasms
Endometrial cancer

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on January 16, 2009