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
  Purpose

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


Condition Intervention
Benign Breast Disease
Breast Cancer
Biological: blood collection for hormonal status analysis
Procedure: breast Biopsy or surgery
Genetic: blood collection
Other: ultrasonography (pelvis and breast), bone mineral density

Study Type: Observational
Study Design: Time Perspective: Cross-Sectional
Official Title: Characterization and Implication of Prolactin Receptor Mutants in Human Breast Diseases

Resource links provided by NLM:


Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • Sequencing of PRLR [ Time Frame: at inclusion ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Biospecimen Retention:   Samples Without DNA

blood collection breast Biopsy or surgery


Enrollment: 735
Study Start Date: September 2008
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1
benign breast diseases
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
2
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
3
control
Biological: blood collection for hormonal status analysis
for hormonal status analysis
Other Name: blood collection for hormonal status analysis
Genetic: blood collection
blood collection for prlR gene sequencing
Other Name: blood collection

Detailed 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.
  Eligibility

Ages Eligible for Study:   10 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00842465

Locations
France
Pitié Salpêtrière Hospital
Paris, France, 75013
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Institut Pasteur
Investigators
Principal Investigator: Philippe Touraine, MD, PhD Assistance Publique - Hôpitaux de Paris
  More Information

No publications provided

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT00842465     History of Changes
Other Study ID Numbers: P070608
Study First Received: January 13, 2009
Last Updated: November 21, 2013
Health Authority: France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Breast diseases,
human mutation,
prolactin receptor;
breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Fibrocystic Breast Disease
Neoplasms by Site
Neoplasms
Skin Diseases

ClinicalTrials.gov processed this record on August 21, 2014