NCT00842465

Brief 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
735

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2008

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2008

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 13, 2009

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 12, 2009

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
Last Updated

November 25, 2013

Status Verified

October 1, 2012

Enrollment Period

3.8 years

First QC Date

January 13, 2009

Last Update Submit

November 21, 2013

Conditions

Benign Breast DiseaseBreast Cancer

Keywords

Breast diseases,human mutation,prolactin receptor;breast cancer

Outcome Measures

Primary Outcomes (1)

  • Sequencing of PRLR

    at inclusion

Secondary Outcomes (7)

  • Breast ultrasonography

    at inclusion

  • Breast MRI

    at inclusion

  • Pelvic ultrasonography

    at inclusion

  • Bone mineral density measurement

    at inclusion

  • Hormonal and metabolic evaluation

    at inclusion

  • +2 more secondary outcomes

Study Arms (3)

1

benign breast diseases

Biological: blood collection for hormonal status analysisProcedure: breast Biopsy or surgeryGenetic: blood collectionOther: ultrasonography (pelvis and breast), bone mineral density

2

breast cancer

Biological: blood collection for hormonal status analysisProcedure: breast Biopsy or surgeryGenetic: blood collectionOther: ultrasonography (pelvis and breast), bone mineral density

3

control

Biological: blood collection for hormonal status analysisGenetic: blood collection

Interventions

blood collection for hormonal status analysisBIOLOGICAL

for hormonal status analysis

123
breast Biopsy or surgeryPROCEDURE

breast Biopsy or surgery

12
blood collectionGENETIC

blood collection for prlR gene sequencing

123
ultrasonography (pelvis and breast), bone mineral densityOTHER

ultrasonography (pelvis and breast), bone mineral density

12

Eligibility Criteria

Age10 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • benign breast diseases
  • \< age \< 25 for simple FA
  • \< 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 :
  • \< age \< 60
  • signature of the icf

You may not qualify if:

  • no signature or no conformity of the icf
  • no social security

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pitié Salpêtrière Hospital

Paris, 75013, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood collection breast Biopsy or surgery

MeSH Terms

Conditions

Cystic FibrosisBreast NeoplasmsBreast Diseases

Interventions

Surgical Procedures, OperativeBlood Specimen CollectionHigh-Energy Shock WavesBone Density

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System DiseasesLung DiseasesRespiratory Tract DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesInfant, Newborn, DiseasesNeoplasms by SiteNeoplasmsSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesInvestigative TechniquesUltrasonic WavesSoundRadiation, NonionizingRadiationPhysical PhenomenaMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Philippe Touraine, MD, PhD

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 13, 2009

First Posted

February 12, 2009

Study Start

September 1, 2008

Primary Completion

June 1, 2012

Study Completion

June 1, 2012

Last Updated

November 25, 2013

Record last verified: 2012-10

Locations

FR(1)