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

NCT ID: NCT01114464

Last Updated: 2016-08-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

250 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-01-31

Study Completion Date

2014-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Ovarian Reserve

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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young women with breast cancer

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* female 18-39 years
* suffering from breast cancer
* treated with adjuvant or neoadjuvant chemotherapy
Minimum Eligible Age

18 Years

Maximum Eligible Age

39 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Nantes University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Paul Barrière, MD

Role: PRINCIPAL_INVESTIGATOR

Nantes University Hospital

Locations

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Institut Bergonié

Bordeaux, , France

Site Status

Centre François BACLESSE

Caen, , France

Site Status

Centre Jean Perrin

Clermont-Ferrand, , France

Site Status

CRLC de Bourgogne Georges François Leclerc

Dijon, , France

Site Status

Centre Oscar Lambret

Lille, , France

Site Status

Centre de Lutte Contre le Cancer Léon Bérard

Lyon, , France

Site Status

Centre Val d'Aurelle - Paul Lamarque

Montpellier, , France

Site Status

Institut Curie

Paris, , France

Site Status

Institut Jean Godinot

Reims, , France

Site Status

Centre Eugène Marquis

Rennes, , France

Site Status

Centre de Lutte Contre le Cancer Nantes Atlantique René Gauducheau

Saint-Herblain, , France

Site Status

Countries

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France

References

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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.

Reference Type DERIVED
PMID: 38957151 (View on PubMed)

Other Identifiers

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BRD/09/06-J

Identifier Type: -

Identifier Source: org_study_id

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