NCT00204997

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

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2002

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

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

September 1, 2002

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2005

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 20, 2005

Completed
2.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2008

Completed
Last Updated

November 15, 2019

Status Verified

June 1, 2008

Enrollment Period

3 years

First QC Date

September 13, 2005

Last Update Submit

November 13, 2019

Conditions

Cervical Cancer

Keywords

Cervical CancerSquamous CellLaparoscopyOvarian Function

Outcome Measures

Primary Outcomes (1)

  • Menopause

    6 months

Study Arms (1)

1

EXPERIMENTAL

Laparoscopic Ovarian Transposition

Procedure: Laparoscopic ovarian transposition

Interventions

Laparoscopic ovarian transpositionPROCEDURE

Laparoscopic ovarian transposition

1

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Wisconsin

Madison, Wisconsin, 53792, United States

Location

Related Links

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine 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
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 20, 2005

Study Start

September 1, 2002

Primary Completion

September 1, 2005

Study Completion

February 1, 2008

Last Updated

November 15, 2019

Record last verified: 2008-06

Locations

US(1)