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

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ClinicalTrials.gov Identifier: NCT00462969
Recruitment Status : Completed
First Posted : April 19, 2007
Last Update Posted : February 2, 2015
Sponsor:
Collaborator:
American College of Obstetricians and Gynecologists
Information provided by (Responsible Party):
University of Wisconsin, Madison

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

Condition or disease Intervention/treatment Phase
Endometrial Cancer Procedure: Sonohysterography Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
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
Study Start Date : April 2007
Actual Primary Completion Date : September 2010
Actual Study Completion Date : September 2010

Arm Intervention/treatment
Experimental: 1
pre-surgical SHG
Procedure: Sonohysterography
Sonohysterography




Primary Outcome Measures :
  1. Cytology results [ Time Frame: At completion of enrollment ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

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

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 Posted: April 19, 2007    Key Record Dates
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