Ovarian Reserve Clinical Trial
— ResovaOfficial title:
Impact of Chemotherapy on Ovarian Reserve in Young Women With Breast Cancer
Verified date | August 2016 |
Source | Nantes University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | France: Ministry of Health |
Study type | Observational |
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.
Status | Terminated |
Enrollment | 250 |
Est. completion date | April 2014 |
Est. primary completion date | April 2014 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 39 Years |
Eligibility |
Inclusion Criteria: - female 18-39 years - suffering from breast cancer - treated with adjuvant or neoadjuvant chemotherapy |
Observational Model: Case-Only, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
France | Institut Bergonié | Bordeaux | |
France | Centre François BACLESSE | Caen | |
France | Centre Jean Perrin | Clermont-Ferrand | |
France | CRLC de Bourgogne Georges François Leclerc | Dijon | |
France | Centre Oscar Lambret | Lille | |
France | Centre de Lutte Contre le Cancer Léon Bérard | Lyon | |
France | Centre Val d'Aurelle - Paul Lamarque | Montpellier | |
France | Institut Curie | Paris | |
France | Institut Jean Godinot | Reims | |
France | Centre Eugène Marquis | Rennes | |
France | Centre de Lutte Contre le Cancer Nantes Atlantique René Gauducheau | Saint Herblain |
Lead Sponsor | Collaborator |
---|---|
Nantes University Hospital |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To evaluate the effects of adjuvant or neoadjuvant chemotherapy treatment on ovarian reserve for in situ breast cancer patients | Serum anti-Müllerian hormone concentration will be measured at each chemotherapy administration and 24 months follow-up after chemotherapy completion | 24 months | No |
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