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Disseminated Endometrial Cancer Cells During Sonohysterography

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00205023
First Posted: September 20, 2005
Last Update Posted: October 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.
Information provided by (Responsible Party):
University of Wisconsin, Madison
  Purpose
The purpose of study is to: 1) determine critical volume necessary to overcome tubal pressure and result in fluid dissemination and 2) evaluate functional viability of any disseminated tumor cells collected during SHG

Condition Intervention
Endometrial Cancer Procedure: Sonohysterography

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: The Incidence of Disseminated Endometrial Cancer Cells During Sonohysterography and Their Functional Viability: a Prospective Study

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

Primary Outcome Measures:
  • determine the critical volume necessary to overcome tubal pressure and result in fluid dissemination during SHG [ Time Frame: during surgery ]

Secondary Outcome Measures:
  • evaluate the functional viability of any disseminated tumor cells collected during SHG [ Time Frame: during surgery ]

Enrollment: 25
Study Start Date: January 2004
Study Completion Date: August 2006
Primary Completion Date: February 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A Procedure: Sonohysterography
SHG during surgery for endometrial cancer.

  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:

  • Stage I endometrial Cancer Disease
  • State IIA endometrial Cancer Disease

Exclusion Criteria:

  • Prior tubal ligation
  • Prior bilateral salpingectomy
  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): NCT00205023


Locations
United States, Wisconsin
University of Wisconsin
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
University of Wisconsin, Madison
Investigators
Principal Investigator: David M Kushner, MD University of Wisconsin, Madison
  More Information

Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT00205023     History of Changes
Other Study ID Numbers: CO 03702
First Submitted: September 13, 2005
First Posted: September 20, 2005
Last Update Posted: October 2, 2015
Last Verified: June 2008

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


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