Study Results
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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COMPLETED
735 participants
OBSERVATIONAL
2008-09-30
2012-06-30
Brief Summary
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The aim of this project is to identify and to characterize new mutants of the prolactin receptor gene within cohorts of benign or malign breast diseases with low or high occurrence frequency in human populations
Detailed Description
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This result suggests that PRLR mutants may have a strong physiopathological impact on breast diseases etiology and/or development and/or evolution.
Based on this, we will pursue the identification of new PRLR mutants in various breast diseases and continue their in vitro functional characterization and then analyse their in vivo consequences on breast tissue samples collected within these women.
1. In a first time we wish to confirm our previous results on multiple fibroadenomas (MFA). The current cohort will be augmented with 30 to 35 new patients each year. We will confirm our in vitro results in vivo with tumoral and peri-tumoral tissue samples.
2. We then wish to extend this study to other rare breast pathologies (i.e. gigantomastia, phyllodies tumors, giant fibroadenomas) and to more common ones (simple fibroadenomas) to demonstrate a link between simple FA and MFA.
3. in a third time we will try to determinate whether a constitutive activation of PRLR leads to enhanced occurrence of benign / malign transitions.
Conditions
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Keywords
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Study Design
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CROSS_SECTIONAL
Study Groups
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1
benign breast diseases
blood collection for hormonal status analysis
for hormonal status analysis
breast Biopsy or surgery
breast Biopsy or surgery
blood collection
blood collection for prlR gene sequencing
ultrasonography (pelvis and breast), bone mineral density
ultrasonography (pelvis and breast), bone mineral density
2
breast cancer
blood collection for hormonal status analysis
for hormonal status analysis
breast Biopsy or surgery
breast Biopsy or surgery
blood collection
blood collection for prlR gene sequencing
ultrasonography (pelvis and breast), bone mineral density
ultrasonography (pelvis and breast), bone mineral density
3
control
blood collection for hormonal status analysis
for hormonal status analysis
blood collection
blood collection for prlR gene sequencing
Interventions
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blood collection for hormonal status analysis
for hormonal status analysis
breast Biopsy or surgery
breast Biopsy or surgery
blood collection
blood collection for prlR gene sequencing
ultrasonography (pelvis and breast), bone mineral density
ultrasonography (pelvis and breast), bone mineral density
Eligibility Criteria
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Inclusion Criteria
* 10 \< age \< 25 for simple FA
* 10 \< age \< 50 for other diseases .no hormonal treatment for at least 3 months if patients took cyproterone acetate; 1 month for other ovaries-interfering hormonal treatment, and 1 week for ovaries-non-interfering hormonal treatments.
* Signature of the informed consent form (icf) by patients or their legal representative (for patients under age of 18.)
* breast cancer :
* having a breast cancer with a planned surgery
* age \> 55 years
* post menopausal with not menopause substitution treatment
* signature of the icf
* control group :
* 18 \< age \< 60
* signature of the icf
Exclusion Criteria
* no social security
10 Years
FEMALE
No
Sponsors
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Institut Pasteur
INDUSTRY
Assistance Publique - Hôpitaux de Paris
OTHER
Responsible Party
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Principal Investigators
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Philippe Touraine, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Assistance Publique - Hôpitaux de Paris
Locations
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Pitié Salpêtrière Hospital
Paris, , France
Countries
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Other Identifiers
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P070608
Identifier Type: -
Identifier Source: org_study_id