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

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ClinicalTrials.gov Identifier: NCT01114464
Recruitment Status : Terminated (end of normal study)
First Posted : May 3, 2010
Last Update Posted : August 8, 2016
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease
Ovarian Reserve

Study Design

Study Type : Observational
Actual Enrollment : 250 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Impact of Chemotherapy on Ovarian Reserve in Young Women With Breast Cancer
Study Start Date : January 2010
Primary Completion Date : April 2014
Study Completion Date : April 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
U.S. FDA Resources

Groups and Cohorts

Group/Cohort
young women with breast cancer


Outcome Measures

Primary Outcome Measures :
  1. To evaluate the effects of adjuvant or neoadjuvant chemotherapy treatment on ovarian reserve for in situ breast cancer patients [ Time Frame: 24 months ]
    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

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 39 Years   (Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Nantes University Hospital
ClinicalTrials.gov Identifier: NCT01114464     History of Changes
Other Study ID Numbers: BRD/09/06-J
First Posted: May 3, 2010    Key Record Dates
Last Update Posted: August 8, 2016
Last Verified: August 2016

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

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