Impact of Chemotherapy on Ovarian Reserve in Young Women With Breast Cancer (Resova)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Nantes University Hospital
ClinicalTrials.gov Identifier:
NCT01114464
First received: April 28, 2010
Last updated: September 27, 2013
Last verified: September 2013
  Purpose

The aim of this protocol is to study the deleterious impact of adjuvant chemotherapy or neoadjuvant chemotherapy on ovarian reserve in young women suffering from breast cancer. A new relevant ovarian reserve marker, serum Anti-Mullerian Hormone, will be used in order to evaluate precisely the impact of chemotherapy on ovaries during chemotherapy administrations and after during follow-up (24 months). This strategy offers 2 main advantages : no modification of the traditional care of patients (treatment, organisation, follow up …) and use of a non invasive marker (serum). The final objective is to give precise information to patients on their future fertility after remission.


Condition
Ovarian Reserve

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Impact of Chemotherapy on Ovarian Reserve in Young Women With Breast Cancer

Resource links provided by NLM:


Further study details as provided by Nantes University Hospital:

Primary Outcome Measures:
  • To evaluate the effects of adjuvant or neoadjuvant chemotherapy treatment on ovarian reserve for in situ breast cancer patients [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Serum anti-Müllerian hormone concentration will be measured at each chemotherapy administration and 24 months follow-up after chemotherapy completion


Biospecimen Retention:   Samples Without DNA

Serum


Enrollment: 250
Study Start Date: January 2010
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
young women with breast cancer

  Eligibility

Ages Eligible for Study:   18 Years to 39 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Young women with breast cancer

Criteria

Inclusion Criteria:

  • female 18-39 years
  • suffering from breast cancer
  • treated with adjuvant or neoadjuvant chemotherapy
  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: NCT01114464

Locations
France
Institut Bergonié
Bordeaux, France, 33076
Centre François BACLESSE
Caen, France, 14076
Centre Jean Perrin
Clermont-Ferrand, France, 63011
CRLC de Bourgogne Georges François Leclerc
Dijon, France, 21079
Centre Oscar Lambret
Lille, France, 59000
Centre de Lutte Contre le Cancer Léon Bérard
Lyon, France, 69373
Centre Val d'Aurelle - Paul Lamarque
Montpellier, France, 34098
Institut Curie
Paris, France, 75005
Institut Jean Godinot
Reims, France, 51056
Centre Eugène Marquis
Rennes, France, 35042
Centre de Lutte Contre le Cancer Nantes Atlantique René Gauducheau
Saint Herblain, France, 44805
Sponsors and Collaborators
Nantes University Hospital
Investigators
Principal Investigator: Paul Barrière, MD Nantes University Hospital
  More Information

No publications provided

Responsible Party: Nantes University Hospital
ClinicalTrials.gov Identifier: NCT01114464     History of Changes
Other Study ID Numbers: BRD09/6-J
Study First Received: April 28, 2010
Last Updated: September 27, 2013
Health Authority: France: Ministry of Health

Keywords provided by Nantes University Hospital:
Breast cancer
Ovarian reserve
Anti-Mullerian Hormone (AMH)
Chemotherapy

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases

ClinicalTrials.gov processed this record on October 23, 2014