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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00462969
First Posted: April 19, 2007
Last Update Posted: February 2, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
American College of Obstetricians and Gynecologists
Information provided by (Responsible Party):
University of Wisconsin, Madison
  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

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
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 ]

Enrollment: 40
Study Start Date: April 2007
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00462969


Locations
United States, Wisconsin
University of Wisconsin
Madison, Wisconsin, United States, 553792
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, Madison
ClinicalTrials.gov Identifier: NCT00462969     History of Changes
Other Study ID Numbers: CC06701
H-2006-0333 ( Other Identifier: Health Sciences Institutional Review Board )
First Submitted: April 17, 2007
First Posted: April 19, 2007
Last Update Posted: February 2, 2015
Last Verified: January 2015

Keywords provided by University of Wisconsin, Madison:
Endometrial cancer
Sonohysterography

Additional relevant MeSH terms:
Endometrial Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Diseases
Genital Diseases, Female