Disseminated Endometrial Cancer Cells During Sonohysterog... | NCT00205023

Studies
Disseminated Endometrial Cancer Cells During Sonohysterography

NCT00205023

Sponsor

University of Wisconsin, Madison

Status

Completed

Last Update Posted

Nov 19, 2019Actual

Enrollment

25Actual

Phase

Not Applicable

Conditions

Endometrial Cancer

Interventions

Sonohysterography

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description
H-2003-0499	Other Identifier	Institutional Review Board
A532820	Other Identifier	UW Madison
SMPH/OBSTET & GYNECOL	Other Identifier	UW Madison

Status Module

Record Verification Date

Jun 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2004

Primary Completion Date

Feb 2006Actual

Completion Date

Aug 2006Actual

First Submitted Date

Sep 13, 2005

First Submission Date that Met QC Criteria

Sep 13, 2005

First Posted Date

Sep 20, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 15, 2019

Last Update Posted Date

Nov 19, 2019Actual

Description Module

Brief Summary

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

25Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
A	Experimental		Procedure: Sonohysterography

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Sonohysterography	Procedure	SHG during surgery for endometrial cancer.	A

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
determine the critical volume necessary to overcome tubal pressure and result in fluid dissemination during SHG		during surgery

Secondary Outcomes

Measure	Description	Time Frame
evaluate the functional viability of any disseminated tumor cells collected during SHG		during surgery

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Stage I endometrial Cancer Disease
State IIA endometrial Cancer Disease

Exclusion Criteria:

Prior tubal ligation
Prior bilateral salpingectomy

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
David M Kushner, MD	University of Wisconsin, Madison	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Wisconsin		Madison	Wisconsin	53792	United States

Label	URL
University of Wisconsin Carbone Cancer Center	View source

Condition Browse Module

MeSH Terms

ID	Term
D016889	Endometrial Neoplasms

Ancestor Terms

ID	Term
D014594	Uterine Neoplasms
D005833	Genital Neoplasms, Female
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site

Browse Leaves

Not provided

Browse Branches

Not provided