Prolactin Receptor and Breast Diseases (Prolacsein)

This study has been completed.
Sponsor:
Collaborator:
Institut Pasteur
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT00842465
First received: January 13, 2009
Last updated: November 21, 2013
Last verified: October 2012

January 13, 2009
November 21, 2013
September 2008
June 2012   (final data collection date for primary outcome measure)
Sequencing of PRLR [ Time Frame: at inclusion ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00842465 on ClinicalTrials.gov Archive Site
  • Breast ultrasonography [ Time Frame: at inclusion ] [ Designated as safety issue: No ]
  • Breast MRI [ Time Frame: at inclusion ] [ Designated as safety issue: No ]
  • Pelvic ultrasonography [ Time Frame: at inclusion ] [ Designated as safety issue: No ]
  • Bone mineral density measurement [ Time Frame: at inclusion ] [ Designated as safety issue: No ]
  • Hormonal and metabolic evaluation [ Time Frame: at inclusion ] [ Designated as safety issue: No ]
  • Histological analysis of tumoral and peri-tumoral tissues [ Time Frame: at surgery ] [ Designated as safety issue: No ]
  • Tumor transcriptome analysis [ Time Frame: at surgery ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Prolactin Receptor and Breast Diseases
Characterization and Implication of Prolactin Receptor Mutants in Human Breast Diseases

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

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.
Observational
Time Perspective: Cross-Sectional
Not Provided
Retention:   Samples Without DNA
Description:

blood collection breast Biopsy or surgery

Non-Probability Sample

Benign breast diseases(60 simple FA, 71 other breast diseases) Brest Cancer : 132 Control : 525

  • Benign Breast Disease
  • Breast Cancer
  • Biological: blood collection for hormonal status analysis
    for hormonal status analysis
    Other Name: blood collection for hormonal status analysis
  • Procedure: breast Biopsy or surgery
    breast Biopsy or surgery
    Other Name: breast Biopsy or surgery
  • Genetic: blood collection
    blood collection for prlR gene sequencing
    Other Name: blood collection
  • Other: ultrasonography (pelvis and breast), bone mineral density
    ultrasonography (pelvis and breast), bone mineral density
    Other Name: ultrasonography (pelvis and breast), bone mineral density
  • 1
    benign breast diseases
    Interventions:
    • Biological: blood collection for hormonal status analysis
    • Procedure: breast Biopsy or surgery
    • Genetic: blood collection
    • Other: ultrasonography (pelvis and breast), bone mineral density
  • 2
    breast cancer
    Interventions:
    • Biological: blood collection for hormonal status analysis
    • Procedure: breast Biopsy or surgery
    • Genetic: blood collection
    • Other: ultrasonography (pelvis and breast), bone mineral density
  • 3
    control
    Interventions:
    • Biological: blood collection for hormonal status analysis
    • Genetic: blood collection
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
735
June 2012
June 2012   (final data collection date for primary outcome measure)

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
Female
10 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00842465
P070608
Yes
Assistance Publique - Hôpitaux de Paris
Assistance Publique - Hôpitaux de Paris
Institut Pasteur
Principal Investigator: Philippe Touraine, MD, PhD Assistance Publique - Hôpitaux de Paris
Assistance Publique - Hôpitaux de Paris
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP