Preservation of Ovarian Function Via LOT in Squamous Cell Carcinoma of the Cervix - Tabular View

Tracking Information

First Received Date ^ICMJE

September 13, 2005

Last Updated Date

June 10, 2008

Start Date ^ICMJE

September 2002

Primary Completion Date

September 2005 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Menopause [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Menopause [ Time Frame: 6 months ]

Change History

Complete list of historical versions of study NCT00204997 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Preservation of Ovarian Function Via LOT in Squamous Cell Carcinoma of the Cervix

Official Title ^ICMJE

Preservation of Ovarian Function Via Laparoscopic Transposition in Patients With Locally Advanced Squamous Cell Carcinoma of the Cervix

Brief Summary

The purpose of this study is to evaluate the feasibility, safety and efficacy of laparoscopic ovarian transposition in women less than 40 years of age with locally advanced cervical squamous cell carcinoma

Detailed Description

Study Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study

Condition ^ICMJE

Cervical Cancer

Intervention ^ICMJE

Procedure: Laparoscopic ovarian transposition

Study Arms / Comparison Groups

Experimental: Laparoscopic Ovarian Transposition

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Estimated Enrollment ^ICMJE

Completion Date

February 2008

Primary Completion Date

September 2005 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Newly diagnosed Stages iB-iiiB squamous cell carcinoma of the cervix

Exclusion Criteria:

Evidence of ovarian involvement on MRI
Evidence of uterine involvement on MRI
Evidence of distant mets on MRI

Gender

Female

Ages

18 Years to 40 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00204997

Responsible Party

David M. Kushner, University of Wisconsin

Study ID Numbers ^ICMJE

CO 02702, 2002-255

Study Sponsor ^ICMJE

University of Wisconsin, Madison

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

David M Kushner, MD

University of Wisconsin, Madison

Information Provided By

University of Wisconsin, Madison

Verification Date

June 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP