French Observatory of Rare Malignant Tumors of the Ovary

Tracking Information
First Submitted Date	September 9, 2005
First Posted Date	February 25, 2011
Last Update Posted Date	April 20, 2012
Study Start Date	January 2002
Primary Completion Date	Not Provided
Current Primary Outcome Measures	Not Provided
Original Primary Outcome Measures	Not Provided
Change History	Complete list of historical versions of study NCT01304043 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures	Not Provided
Original Secondary Outcome Measures	Not Provided
Current Other Outcome Measures	Not Provided
Original Other Outcome Measures	Not Provided
Descriptive Information
Brief Title	French Observatory of Rare Malignant Tumors of the Ovary
Official Title	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	Observational
Study Design	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	Ovarian Tumors
Intervention	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	Completed
Actual Enrollment; (submitted: February 28, 2012)	204
Original Estimated Enrollment; (submitted: February 24, 2011)	150
Actual Study Completion Date	June 2011
Primary Completion Date	Not Provided
Eligibility Criteria	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	No
Contacts	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries	France
Removed Location Countries
Administrative Information
NCT Number	NCT01304043
Other Study ID Numbers	TMRO
Has Data Monitoring Committee	No
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	ARCAGY/ GINECO GROUP
Study Sponsor	ARCAGY/ GINECO GROUP
Collaborators	Not Provided
Investigators	Principal Investigator: Isabelle Ray-Coquard, Physician GINECO
PRS Account	ARCAGY/ GINECO GROUP
Verification Date	April 2012