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

• Sponsor: University of Wisconsin, Madison (Other)
• Overall Status: Completed
• CT.gov ID: NCT00462969
• Collaborator: American College of Obstetricians and Gynecologists (Other), National Cancer Institute (NCI) (NIH)
• Enrollment: 40
• Location: 1
• Arm: 1
• Duration (Months): 41
• Patients Per Site Per Month: 1

Study Details

Study Description

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	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 40 participants
• Allocation: N/A
• 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: Apr 1, 2007
• Actual Primary Completion Date: Sep 1, 2010
• Actual Study Completion Date: Sep 1, 2010

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Cytology results [At completion of enrollment]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Newly diagnosed early-stage endometrial cancer

Exclusion Criteria:

• Recurrent or persistent endometrial cancer

• Evidence of distant metastases

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Wisconsin	Madison	Wisconsin	United States	553792

Sponsors and Collaborators

• University of Wisconsin, Madison
• American College of Obstetricians and Gynecologists
• National Cancer Institute (NCI)

Investigators

• Principal Investigator: David M Kushner, MD, University of Wisconsin, Madison

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• University of Wisconsin Carbone Cancer Center

Publications

None provided.

• Responsible Party: University of Wisconsin, Madison
• ClinicalTrials.gov Identifier: NCT00462969
• Other Study ID Numbers: CC06701; H-2006-0333; NCI-2014-01355; A532820; SMPH\OBSTET & GYNECOL\ONC; P30CA014520
• First Posted: Apr 19, 2007
• Last Update Posted: Nov 19, 2019
• Last Verified: Jan 1, 2015

• Keywords provided by University of Wisconsin, Madison: Endometrial cancer; Sonohysterography
• Additional relevant MeSH terms: Endometrial Neoplasms

Study Results

No Results Posted as of Nov 19, 2019