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

Sponsor
Nantes University Hospital (Other)
Overall Status
Terminated
CT.gov ID
NCT01114464
Collaborator
(none)
250
Enrollment
11
Locations
51
Duration (Months)
22.7
Patients Per Site
0.4
Patients Per Site Per Month

Study Details

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 Intervention/Treatment Phase

    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 :
    Jan 1, 2010
    Actual Primary Completion Date :
    Apr 1, 2014
    Actual Study Completion Date :
    Apr 1, 2014

    Arms and Interventions

    Arm Intervention/Treatment
    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 [24 months]

      Serum anti-Müllerian hormone concentration will be measured at each chemotherapy administration and 24 months follow-up after chemotherapy completion

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 39 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • female 18-39 years

    • suffering from breast cancer

    • treated with adjuvant or neoadjuvant chemotherapy

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Institut Bergonié Bordeaux France 33076
    2 Centre François BACLESSE Caen France 14076
    3 Centre Jean Perrin Clermont-Ferrand France 63011
    4 CRLC de Bourgogne Georges François Leclerc Dijon France 21079
    5 Centre Oscar Lambret Lille France 59000
    6 Centre de Lutte Contre le Cancer Léon Bérard Lyon France 69373
    7 Centre Val d'Aurelle - Paul Lamarque Montpellier France 34098
    8 Institut Curie Paris France 75005
    9 Institut Jean Godinot Reims France 51056
    10 Centre Eugène Marquis Rennes France 35042
    11 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Nantes University Hospital
    ClinicalTrials.gov Identifier:
    NCT01114464
    Other Study ID Numbers:
    • BRD/09/06-J
    First Posted:
    May 3, 2010
    Last Update Posted:
    Aug 8, 2016
    Last Verified:
    Aug 1, 2016
    Keywords provided by Nantes University Hospital
    Breast cancer
    Ovarian reserve
    Anti-Mullerian Hormone (AMH)
    Chemotherapy
    Additional relevant MeSH terms:
    Breast Neoplasms

    Study Results

    No Results Posted as of Aug 8, 2016