French Observatory of Rare Malignant Tumors of the Ovary

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

ARCAGY/ GINECO GROUP

ClinicalTrials.gov Identifier:

NCT01304043

First received: September 9, 2005

Last updated: April 19, 2012

Last verified: April 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

September 9, 2005

Last Updated Date

April 19, 2012

Start Date ^ICMJE

January 2002

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

Not Provided

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT01304043 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

French Observatory of Rare Malignant Tumors of the Ovary

Official Title ^ICMJE

Observatoire Francophone Des Tumeurs Malignes Rares de l'Ovaire : Protocole de Prise en Charge Chez l'Adulte (Tumeurs Germinales et Des Cordons Sexuels)

Brief Summary

To take charge of the treatment in rare adult ovarian tumors with an homogenous manner (germinal and sexual cords tumors), at different stages of the disease.

Detailed Description

to establish prognosis factors for the disease
to proceed in a centralised examination of histologic laminas
to reach in the long-term and homogenous follow-up of the patients
to follow-up the long-term toxicities of the treatments given
to analyse and follow-up the later fertility of the patients
to evaluate the interest of setting a multi-disciplinary discussion forum on the Web

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Cohort
Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

Sampling Method

Non-Probability Sample

Study Population

female with rare ovarian cancer

Condition ^ICMJE

Ovarian Tumors

Intervention ^ICMJE

Drug: chemotherapies protocols

Cisplatine 20 mg/m² IV Etoposide 100 mg/m² IV Bléomycine 30 mg IV

Study Groups/Cohorts

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

204

Completion Date

June 2011

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

Inclusion Criteria:

age > 18 years old
germinal or sexual cords ovary tumors histologically proven
first line or relapse treatment
written informed consent

Exclusion Criteria:

mental ineptitude to understand and follow the study

Sex/Gender

Sexes Eligible for Study:

Female

Ages

18 Years and older (Adult, Senior)

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

France

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT01304043

Other Study ID Numbers ^ICMJE

TMRO

Has Data Monitoring Committee

U.S. FDA-regulated Product

Not Provided

IPD Sharing Statement

Not Provided

Responsible Party

ARCAGY/ GINECO GROUP

Study Sponsor ^ICMJE

ARCAGY/ GINECO GROUP

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Isabelle Ray-Coquard, Physician

GINECO

PRS Account

ARCAGY/ GINECO GROUP

Verification Date

April 2012

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

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