Prolactin Receptor and Breast Diseases

Breast Cancer Clinical Trial

— Prolacsein  

Official title:

Characterization and Implication of Prolactin Receptor Mutants in Human Breast Diseases

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00842465
• Other study ID #: P070608
• Status: Completed
• Phase: N/A
• First received: January 13, 2009
• Last updated: November 21, 2013
• Start date: September 2008
• Est. completion date: June 2012

Study information

• Verified date: October 2012
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Observational

Clinical Trial Summary

Prolactin is known to play an important role in breast development and differentiation. Thus proliferative breast diseases are good models to unravel PRl / PRLR function in proliferative processes.

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

Description:

There is currently no known genetic disease linked to prolactin (prl) or its receptor (prlR) in humans. In a previous work, we have identified a new mutation of prolactin receptor that leads to it's constitutive activation and to cell proliferation signalling cascades (i.e. through MAP kinases).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 735
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 10 Years and older

Eligibility

Inclusion criteria :

• benign breast diseases

• 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 signature or no conformity of the icf

• no social security

Study Design

Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Benign Breast Disease
• Breast Cancer
• Breast Diseases

Intervention

Biological:
• blood collection for hormonal status analysis
for hormonal status analysis

Procedure:
• breast Biopsy or surgery
breast Biopsy or surgery

Genetic:
• blood collection
blood collection for prlR gene sequencing

Other:
• ultrasonography (pelvis and breast), bone mineral density
ultrasonography (pelvis and breast), bone mineral density

Locations

Country	Name	City	State
France	Pitié Salpêtrière Hospital	Paris

Sponsors (2)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris	Institut Pasteur

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sequencing of PRLR		at inclusion	No
Secondary	Breast ultrasonography		at inclusion	No
Secondary	Breast MRI		at inclusion	No
Secondary	Pelvic ultrasonography		at inclusion	No
Secondary	Bone mineral density measurement		at inclusion	No
Secondary	Hormonal and metabolic evaluation		at inclusion	No
Secondary	Histological analysis of tumoral and peri-tumoral tissues		at surgery	No
Secondary	Tumor transcriptome analysis		at surgery	No