NCT00462969

Brief Summary

The purpose of this study is to learn fluid from sonohysterography can be used to diagnose endometrial cancer.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2007

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2007

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

April 17, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 19, 2007

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2010

Completed
Last Updated

November 19, 2019

Status Verified

January 1, 2015

Enrollment Period

3.4 years

First QC Date

April 17, 2007

Last Update Submit

November 15, 2019

Conditions

Endometrial Cancer

Keywords

Endometrial cancerSonohysterography

Outcome Measures

Primary Outcomes (1)

  • Cytology results

    At completion of enrollment

Study Arms (1)

1

EXPERIMENTAL

pre-surgical SHG

Procedure: Sonohysterography

Interventions

SonohysterographyPROCEDURE

Sonohysterography

1

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Newly diagnosed early-stage endometrial cancer

You may not qualify if:

  • Recurrent or persistent endometrial cancer
  • Evidence of distant metastases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Wisconsin

Madison, Wisconsin, 553792, United States

Location

Related Publications (1)

  • Guralp O, Sheridan SM, Harter J, Hinshaw JL, Seo S, Hartenbach EM, Lindheim S, Stewart S, Kushner DM. A new diagnostic test for endometrial cancer?: Cytology analysis of sonohysterography distention media. Int J Gynecol Cancer. 2013 Sep;23(7):1252-7. doi: 10.1097/IGC.0b013e31829fe8f6.

    PMID: 23881100RESULT

Related Links

MeSH Terms

Conditions

Endometrial Neoplasms

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Officials

  • David M Kushner, MD

    University of Wisconsin, Madison

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 17, 2007

First Posted

April 19, 2007

Study Start

April 1, 2007

Primary Completion

September 1, 2010

Study Completion

September 1, 2010

Last Updated

November 19, 2019

Record last verified: 2015-01

Locations

US(1)