Study Stopped
end of normal study
Impact of Chemotherapy on Ovarian Reserve in Young Women With Breast Cancer
Resova
1 other identifier
observational
250
1 country
11
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2010
Longer than P75 for all trials
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2010
CompletedFirst Submitted
Initial submission to the registry
April 28, 2010
CompletedFirst Posted
Study publicly available on registry
May 3, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2014
CompletedAugust 8, 2016
August 1, 2016
4.2 years
April 28, 2010
August 5, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (1)
young women with breast cancer
Eligibility Criteria
Young women with breast cancer
You may qualify if:
- female 18-39 years
- suffering from breast cancer
- treated with adjuvant or neoadjuvant chemotherapy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (11)
Institut Bergonié
Bordeaux, 33076, France
Centre François BACLESSE
Caen, 14076, France
Centre Jean Perrin
Clermont-Ferrand, 63011, France
CRLC de Bourgogne Georges François Leclerc
Dijon, 21079, France
Centre Oscar Lambret
Lille, 59000, France
Centre de Lutte Contre le Cancer Léon Bérard
Lyon, 69373, France
Centre Val d'Aurelle - Paul Lamarque
Montpellier, 34098, France
Institut Curie
Paris, 75005, France
Institut Jean Godinot
Reims, 51056, France
Centre Eugène Marquis
Rennes, 35042, France
Centre de Lutte Contre le Cancer Nantes Atlantique René Gauducheau
Saint-Herblain, 44805, France
Related Publications (1)
Loubersac S, Chaillot M, Reignier A, Lefebvre T, Dezellus A, Colombel A, Barriere P, Masson D, Freour T. Serum androgen dynamics in young women aged 18-40 treated with chemotherapy for breast cancer: an observational, multicentric, prospective study in France. Hum Fertil (Camb). 2024 Dec;27(1):2350758. doi: 10.1080/14647273.2024.2350758. Epub 2024 Jul 3.
PMID: 38957151DERIVED
Biospecimen
Serum
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Paul Barrière, MD
Nantes University Hospital
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 28, 2010
First Posted
May 3, 2010
Study Start
January 1, 2010
Primary Completion
April 1, 2014
Study Completion
April 1, 2014
Last Updated
August 8, 2016
Record last verified: 2016-08