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
  Purpose

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.


Condition Intervention
Ovarian Tumors
Drug: chemotherapies protocols

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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)

Resource links provided by NLM:


Further study details as provided by ARCAGY/ GINECO GROUP:

Enrollment: 204
Study Start Date: January 2002
Study Completion Date: June 2011
Intervention Details:
    Drug: chemotherapies protocols
    Cisplatine 20 mg/m² IV Etoposide 100 mg/m² IV Bléomycine 30 mg IV
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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

female with rare ovarian cancer

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01304043

Locations
France
Oncologie, Hôtel-Dieu, 1 place du parvis Notre-Dame
Paris, France, 75004
Sponsors and Collaborators
ARCAGY/ GINECO GROUP
Investigators
Principal Investigator: Isabelle Ray-Coquard, Physician GINECO
  More Information

Additional Information:
No publications provided

Responsible Party: ARCAGY/ GINECO GROUP
ClinicalTrials.gov Identifier: NCT01304043     History of Changes
Other Study ID Numbers: TMRO
Study First Received: September 9, 2005
Last Updated: April 19, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by ARCAGY/ GINECO GROUP:
ovarian tumors
rare ovarian tumors
germinal tumors
sexual cords tumors
observatory
forum

Additional relevant MeSH terms:
Ovarian Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders

ClinicalTrials.gov processed this record on August 20, 2014