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Disseminated Endometrial Cancer Cells During Sonohysterography

This study has been completed.
Sponsor:
Information provided by:
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT00205023
First received: September 13, 2005
Last updated: June 10, 2008
Last verified: June 2008
History of Changes
  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: Open Label
Official Title: The Incidence of Disseminated Endometrial Cancer Cells During Sonohysterography and Their Functional Viability: a Prospective Study

Resource links provided by NLM:

U.S. FDA Resources

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

Ages Eligible for Study:   18 Years and older
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00205023     History of Changes
Other Study ID Numbers: CO 03702
Study First Received: September 13, 2005
Last Updated: June 10, 2008
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Endometrial Neoplasms
Sarcoma, Endometrial Stromal
Adenoma
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
 Uterine Diseases
Genital Diseases, Female
Neoplasms, Complex and Mixed
Neoplasms by Histologic Type
Sarcoma
Neoplasms, Connective and Soft Tissue
Endometrial Stromal Tumors
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on May 23, 2013