Benign Breast DiseaseProlacseinNCT00842465
Prolactin Receptor and Breast Diseases
An observational study of Benign Breast Disease and Breast Cancer, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 10 years and older, women only
- Conditions the study is for
- Benign Breast Disease, Breast Cancer
- What is being tested?
- blood collection for hormonal status analysis, breast Biopsy or surgery and blood collection
- Type of treatment
- Surgery or procedure
- How many people
- 735 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2008to Jun 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 years and older
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Benign breast diseases(60 simple FA, 71 other breast diseases) Brest Cancer : 132 Control : 525
Who may be able to join
- 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
Show all 12Show fewer
- age > 55 years
- post menopausal with not menopause substitution treatment
- signature of the icf
- control group :
- 18 < age < 60
- signature of the icf
Who cannot join
- no signature or no conformity of the icf
- no social security
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the 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.
- 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.
- 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.
- in a third time we will try to determinate whether a constitutive activation of PRLR leads to enhanced occurrence of benign / malign transitions.
- Conditions
- Benign Breast Disease, Breast Cancer
- Being tested
- blood collection for hormonal status analysis, breast Biopsy or surgery, blood collection, ultrasonography (pelvis and breast), bone mineral density
- Keywords
- Breast diseases,, human mutation,, prolactin receptor;, breast cancer
- Medical subject headings
- Cystic Fibrosis, Breast Neoplasms, Breast Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood collection for hormonal status analysisBiological
for hormonal status analysis
breast Biopsy or surgeryProcedure or surgery
breast Biopsy or surgery
blood collectionGenetic
blood collection for prlR gene sequencing
ultrasonography (pelvis and breast), bone mineral densityOther
ultrasonography (pelvis and breast), bone mineral density
| Study group | Role | What they receive |
|---|---|---|
| 1 | benign breast diseases Receives: 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 Receives: 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 Receives: Biological: blood collection for hormonal status analysis; Genetic: blood collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sequencing of PRLR
Measured: at inclusion
Secondary outcomes (7)
Breast ultrasonography
Measured: at inclusion
Breast MRI
Measured: at inclusion
Pelvic ultrasonography
Measured: at inclusion
Bone mineral density measurement
Measured: at inclusion
Hormonal and metabolic evaluation
Measured: at inclusion
Histological analysis of tumoral and peri-tumoral tissues
Measured: at surgery
Tumor transcriptome analysis
Measured: at surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2009 (estimated)
- Study startSep 2008
- Primary completionJun 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Benign Breast DiseaseStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Cross-sectional
- Enrolment
- 735 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Institut Pasteur
- Responsible party
- Sponsor
- Investigators
- Philippe Touraine, MD, PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00842465
- Sponsor's protocol ID
- P070608
- Acronym
- Prolacsein
- Status last verified
- Oct 2012
- First submitted
- 13 Jan 2009
- Last updated
- 25 Nov 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization and Implication of Prolactin Receptor Mutants in Human Breast Diseases
- ClinicalTrials.gov ID
- NCT00842465
- Acronym / sponsor ID
- Prolacsein / P070608
- Conditions
- Benign Breast Disease, Breast Cancer
- Keywords
- Breast diseases,, human mutation,, prolactin receptor;, breast cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 735 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Institut Pasteur
- Study start
- Sep 2008
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 12 Feb 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
- 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.
- 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.
- in a third time we will try to determinate whether a constitutive activation of PRLR leads to enhanced occurrence of benign / malign transitions.
Study design
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Biological: blood collection for hormonal status analysis, Procedure: breast Biopsy or surgery, Genetic: blood collection, Other: ultrasonography (pelvis and breast), bone mineral densitybenign breast diseases |
| 2 | – | Biological: blood collection for hormonal status analysis, Procedure: breast Biopsy or surgery, Genetic: blood collection, Other: ultrasonography (pelvis and breast), bone mineral densitybreast cancer |
| 3 | – | Biological: blood collection for hormonal status analysis, Genetic: blood collectioncontrol |
Who may qualify
- Ages
- 10 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Benign breast diseases(60 simple FA, 71 other breast diseases) Brest Cancer : 132 Control : 525
Key inclusion criteria (12 listed)
- benign breast diseases
- breast cancer :
- control group :
Key exclusion criteria (2 listed)
- no signature or no conformity of the icf
- no social security
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| blood collection for hormonal status analysisfor hormonal status analysis | Biological | 1, 2, 3 |
| breast Biopsy or surgerybreast Biopsy or surgery | Procedure or surgery | 1, 2 |
| blood collectionblood collection for prlR gene sequencing | Genetic | 1, 2, 3 |
| ultrasonography (pelvis and breast), bone mineral densityultrasonography (pelvis and breast), bone mineral density | Other | 1, 2 |
Primary outcome
Sequencing of PRLR
Time frame: at inclusion
7 secondary outcomes
Breast ultrasonography
Time frame: at inclusion
Breast MRI
Time frame: at inclusion
Pelvic ultrasonography
Time frame: at inclusion
Bone mineral density measurement
Time frame: at inclusion
Hormonal and metabolic evaluation
Time frame: at inclusion
Histological analysis of tumoral and peri-tumoral tissues
Time frame: at surgery
Tumor transcriptome analysis
Time frame: at surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Philippe Touraine, MD, PhD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Benign Breast Disease and Breast Cancer, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sequencing of PRLR (time frame: at inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2013.