Impact of Chemotherapy on Ovarian Reserve in Young Women With Breast Cancer (Resova)
This study has been completed.
Sponsor:
Nantes University Hospital
Information provided by:
Nantes University Hospital
ClinicalTrials.gov Identifier:
NCT01114464
First received: April 28, 2010
Last updated: November 28, 2011
Last verified: November 2011
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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 [ 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 |
| 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
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: | Professeur Paul Barrière, 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: | November 28, 2011 |
| 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 Neoplasms by Site Neoplasms Breast Diseases Skin Diseases |
ClinicalTrials.gov processed this record on May 19, 2013