Breast CancerMediSeinNCT02541188
Genotype and Phenotype in Early Onset Breast Cancer in Young Women on the Two Shores of the Mediterranean Sea
An observational study of Breast Cancer, run by University Hospital, Montpellier at 1 site in France.
Trial summary
Breast cancer are common on mediterranean basin. Epidemiological data suggest that breast cancer in young women (< 40years old) is more aggressive in the Maghreb countries comparatively to western countries. This aggressiveness could be associated with phenotypic and genotypic differences between this two populations. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Genetic analysis
- How many people
- 460 participants
- Where
- 1 siteFrance
- Study dates
- 2 Oct 2014to 2 Jan 2017
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Patients have or have had a breast cancer diagnosed before 40 years old in two shores of the Mediterranean sea (France, lgeria, Marocco, Egypt, Tunisia)
Who may be able to join
- Patient have or have had a breast cancer diagnosed before 40 years old
- Breast cancer proven by histology
- BRCA1/2 analysis proposed, realized, ongoing
- Women >18 years old
- Patient with insurance
- Patient informed and no-opposed
Who cannot join
- Patient have or have had a breast cancer diagnosed after 40 years old
- Patient requiring tutorship or guardianship
- Adult patient protected by law
Trial locations and contacts
1 site in 1 country.
About this study
Breast cancer are common on mediterranean basin. Epidemiological data suggest that breast cancer in young women (< 40years old) is more aggressive in the Maghreb countries comparatively to western countries. This aggressiveness could be associated with phenotypic and genotypic differences between this two populations.
Read the detailed description
The object of this study is to compare the genotypic and phenotypic differences between south and north shore of the mediterranean sea.
- Conditions
- Breast Cancer
- Being tested
- Genetic analysis
- Keywords
- Breast cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Genetic analysisGenetic
| Study group | Role | What they receive |
|---|---|---|
| breast cancer in young women is in the Maghreb | breast cancer in young women (< 40years old) is in the Maghreb Receives: Genetic: Genetic analysis | |
| Breast cancer in young women in the western countries | Breast cancer in young women (< 40years old) in the western countries Receives: Genetic: Genetic analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Genetic analysis of Breast Cancer susceptibility gene 1 (BRCA 1)
Measured: The day of inclusion
Genetic analysis of Breast Cancer susceptibility gene 2 (BRCA 2)
Measured: The day of inclusion
Secondary outcomes (6)
Analysis TNM grade
Tumors will be phenotyped by giving the histological characteristics (TNM and SBR grade, hormone receptors (ER, PR), growth factors (Ki 67) and HER2)
Measured: The day of inclusion
Analysis histoprognostic grade Scarf Bloom and Richardson (SBR)
Tumors will be phenotyped by giving the histological characteristics (TNM and SBR grade, hormone receptors (ER, PR), growth factors (Ki 67) and HER2)
Measured: The day of inclusion
analysis of hormone receptor ER
Tumors will be phenotyped by giving the histological characteristics (TNM and SBR grade, hormone receptors (ER, PR), growth factors (Ki 67) and HER2)
Measured: The day of inclusion
growth factors analysis (Ki 67)
Tumors will be phenotyped by giving the histological characteristics (TNM and SBR grade, hormone receptors (ER, PR), growth factors (Ki 67) and HER2)
Measured: The day of inclusion
analysis of HER2
Tumors will be phenotyped by giving the histological characteristics (TNM and SBR grade, hormone receptors (ER, PR), growth factors (Ki 67) and HER2)
Measured: The day of inclusion
analysis of hormone receptor PR
Tumors will be phenotyped by giving the histological characteristics (TNM and SBR grade, hormone receptors (ER, PR), growth factors (Ki 67) and HER2)
Measured: The day of inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2015 (estimated)
- Study start2 Oct 2014
- Primary completion2 Oct 2016
- Study completion2 Jan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 460 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pascal PUJOL, MDPhD, Principal investigator, Oncogenetic Unit -CHU de Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02541188
- Sponsor's protocol ID
- UF 9428
- Acronym
- MediSein
- Status last verified
- Dec 2021
- First submitted
- 26 Aug 2015
- Last updated
- 10 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genotype and Phenotype in Early Onset Breast Cancer in Young Women on the Two Shores of the Mediterranean Sea
- ClinicalTrials.gov ID
- NCT02541188
- Acronym / sponsor ID
- MediSein / UF 9428
- Conditions
- Breast Cancer
- Keywords
- Breast cancer
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 460 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 2 Oct 2014 (actual)
- Primary completion
- 2 Oct 2016 (actual)
- Study completion
- 2 Jan 2017 (actual)
- First posted
- 4 Sep 2015 (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.
Breast cancer are common on mediterranean basin. Epidemiological data suggest that breast cancer in young women (< 40years old) is more aggressive in the Maghreb countries comparatively to western countries. This aggressiveness could be associated with phenotypic and genotypic differences between this two populations.
Detailed description
The object of this study is to compare the genotypic and phenotypic differences between south and north shore of the mediterranean sea.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| breast cancer in young women is in the Maghreb | – | Genetic: Genetic analysisbreast cancer in young women (< 40years old) is in the Maghreb |
| Breast cancer in young women in the western countries | – | Genetic: Genetic analysisBreast cancer in young women (< 40years old) in the western countries |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients have or have had a breast cancer diagnosed before 40 years old in two shores of the Mediterranean sea (France, lgeria, Marocco, Egypt, Tunisia)
Key inclusion criteria (6 listed)
- Patient have or have had a breast cancer diagnosed before 40 years old
- Breast cancer proven by histology
- BRCA1/2 analysis proposed, realized, ongoing
- Women >18 years old
- Patient with insurance
Key exclusion criteria (3 listed)
- Patient have or have had a breast cancer diagnosed after 40 years old
- Patient requiring tutorship or guardianship
- Adult patient protected by law
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 |
|---|---|---|
| Genetic analysis | Genetic | Breast cancer in young women in the western countries, breast cancer in young women is in the Maghreb |
Primary outcome
Genetic analysis of Breast Cancer susceptibility gene 1 (BRCA 1)
Time frame: The day of inclusion
Genetic analysis of Breast Cancer susceptibility gene 2 (BRCA 2)
Time frame: The day of inclusion
6 secondary outcomes
Analysis TNM grade
Time frame: The day of inclusion
Analysis histoprognostic grade Scarf Bloom and Richardson (SBR)
Time frame: The day of inclusion
analysis of hormone receptor ER
Time frame: The day of inclusion
growth factors analysis (Ki 67)
Time frame: The day of inclusion
analysis of HER2
Time frame: The day of inclusion
analysis of hormone receptor PR
Time frame: The day of inclusion
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2021.
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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.
Pascal PUJOL, MDPhD principal investigator
Oncogenetic Unit -CHU de Montpellier
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 Breast Cancer, run by University Hospital, Montpellier 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 6 inclusion and 3 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: stopped early, as of the sponsor's last update on 10 Dec 2021. 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 was stopped early. Results are not available in the source record.
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?
Genetic analysis of Breast Cancer susceptibility gene 1 (BRCA 1) (time frame: The day of inclusion). The study lists 2 primary outcomes in all. 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 10 Dec 2021.