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

This study has been completed.
Sponsor:
Collaborator:
American College of Obstetricians and Gynecologists
Information provided by (Responsible Party):
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT00462969
First received: April 17, 2007
Last updated: January 30, 2015
Last verified: January 2015
  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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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 )
Study First Received: April 17, 2007
Last Updated: January 30, 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

ClinicalTrials.gov processed this record on August 18, 2017