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:
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT00462969
First received: April 17, 2007
Last updated: March 8, 2011
Last verified: March 2011
  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: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Cytologic Analysis of Distention Media as a Screening Test for Endometrial Cancer

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Cytology results [ Time Frame: At completion of enrollment ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
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
Genders 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

No publications provided

Responsible Party: David M. Kushner, MD, University of Wisconsin
ClinicalTrials.gov Identifier: NCT00462969     History of Changes
Other Study ID Numbers: CC 06701, H-2006-0333
Study First Received: April 17, 2007
Last Updated: March 8, 2011
Health Authority: United States: Federal Government
United States: Institutional Review Board

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

Additional relevant MeSH terms:
Endometrial Neoplasms
Sarcoma, Endometrial Stromal
Dilatation, Pathologic
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
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on July 23, 2014