Hereditary Breast and Ovarian Cancer SyndromePhase 2EXSALNCT01333748
Search Allelic Imbalance of Expression of BRCA Genes in Hereditary Risk of Breast and/or Ovarian Cancer
A Phase 2 study testing blood collection in people with Hereditary Breast and Ovarian Cancer Syndrome, run by Centre Francois Baclesse at 6 sites in France.
Trial summary
The purpose of this study is to determine proportion of patients presented a search allelic imbalance of expression of genes BRCA 1 and 2 in population with hereditary breast and/or ovarian cancer risk and negative for deletion mutation BRCA 1 and 2 genes Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Hereditary Breast and Ovarian Cancer Syndrome
- What is being tested?
- blood collection
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 530 participants
- Where
- 6 sitesFrance
- Study dates
- Apr 2010to Jun 2012
- Phase
- Phase 2
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- For patients
- Women with breast cancer and / or ovarian cancer meet criteria suggestive of a hereditary predisposition
- Deleterious mutation of BRCA1 and BRCA2 sought and not highlighted
- Age ≥ 18 years
- Agreeing to participate in the study (a collection of signed informed consent)
- For control population
- Women with no history of breast and / or ovarian cancer and no family history of breast and / or ovarian cancer among family members on the 1st and 2nd degree before age 50 for breast cancer and before 60 years for ovarian cancer
- Agreeing to participate in the study (a collection of signed informed consent)
Who cannot join
- For patients:
- Patients with a known deleterious mutation in BRCA1 and BRCA2
- Patients do not meet criteria suggestive of a hereditary predisposition
- Persons deprived of liberty or under guardianship (including guardianship)
- For control population:
- Males
- Personal or family history of breast and / or ovarian cancer (breast or ovarian cancer in their family experienced 1st and 2nd degree before age 50 for breast cancer before age 60 for cancer ovarian)
- Persons deprived of liberty or under guardianship (including guardianship)
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
France6 sites
Dr Pascaline BERTHET
Caen, Caen, 14076
Centre Hospitalier
Cherbourg, 50102
Centre Eugène MARQUIS
Rennes, Rennes, 35 000
CHU
Rennes, 35000
Centre Henri BECQUEREL
Rouen, 76038
CHU
Rouen, 76038
About this study
The purpose of this study is to determine proportion of patients presented a search allelic imbalance of expression of genes BRCA 1 and 2 in population with hereditary breast and/or ovarian cancer risk and negative for deletion mutation BRCA 1 and 2 genes
- Being tested
- blood collection
- Keywords
- breast cancer, ovarian cancer, BRCA 1 and BRCA 2
- Medical subject headings
- Hereditary Breast and Ovarian Cancer Syndrome, Breast Neoplasms, Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood collectionGenetic
blood collection for research quantification of allelic expression in the gene BRCA1.
blood collectionGenetic
blood collection for research quantification of allelic expression in the gene BRCA1.
| Study group | Role | What they receive |
|---|---|---|
| patients group | Experimental | Patients with ovarian and/or breast cancer Receives: Genetic: blood collection |
| control population | Other | control population without history of breast and/or ovarian cancer Receives: Genetic: blood collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
estimate the proportion of patients with allelic imbalance at the level of expression of BRCA1
The main objective of this study is to estimate the proportion of patients with allelic imbalance at the level of expression of BRCA1 in a population meeting the criteria suggestive of a hereditary predisposition to breast and / or ovarian cancer , and negative for deleterious mutations of BRCA 1 and BRCA 2.
Measured: blood sample at baseline, no follow-up in this study
Secondary outcomes (3)
Study the variability of the measurement of the allelic expression depending on the position of SNPs
Study the variability of the measurement of the allelic expression depending on the position of SNPs (Single Nucleotide Polymorphism) in the gene, in order to extend this research to variants of unknown significance whatever their position in the gene.
Measured: blood sample at baseline, no follow-up in this study
proportion of patients with allelic imbalance at the level of expression of the BRCA2 gene
Estimate the proportion of patients with allelic imbalance at the level of expression of the BRCA2 gene in the same population.
Measured: blood sample at baseline, no follow-up in this study
Observe the possible effect of age
The frequency of allelic imbalance of expression will be compared depending on the age of the witnesses in the control population. The potential effect of age on the presence or absence of allelic imbalance of expression will be observed.
Measured: blood sample at baseline, no follow-up in this study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2011 (estimated)
- Study startApr 2010
- 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 Hereditary Breast and Ovarian Cancer SyndromeStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 530 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Francois Baclesse
- Sponsor type
- University, hospital or other
- Investigators
- Agnès HARDOUIN, MD, Principal investigator, Centre François Baclesse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01333748
- Sponsor's protocol ID
- EXSAL
- Other IDs
- 2009-A00833-54
- Acronym
- EXSAL
- Status last verified
- Jul 2012
- First submitted
- 4 Apr 2011
- Last updated
- 13 Jul 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Search Allelic Imbalance of Expression of BRCA Genes in Hereditary Risk of Breast and/or Ovarian Cancer
- ClinicalTrials.gov ID
- NCT01333748
- Acronym / sponsor ID
- EXSAL / EXSAL
- Keywords
- breast cancer, ovarian cancer, BRCA 1 and BRCA 2
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 530 participants (estimated)
- Lead sponsor
- Centre Francois BaclesseUniversity, hospital or other
- Study start
- Apr 2010
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 12 Apr 2011 (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.
The purpose of this study is to determine proportion of patients presented a search allelic imbalance of expression of genes BRCA 1 and 2 in population with hereditary breast and/or ovarian cancer risk and negative for deletion mutation BRCA 1 and 2 genes
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients group | Experimental | Genetic: blood collectionPatients with ovarian and/or breast cancer |
| control population | Other | Genetic: blood collectioncontrol population without history of breast and/or ovarian cancer |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- For patients
- Women with breast cancer and / or ovarian cancer meet criteria suggestive of a hereditary predisposition
- Deleterious mutation of BRCA1 and BRCA2 sought and not highlighted
- Age ≥ 18 years
- Agreeing to participate in the study (a collection of signed informed consent)
Key exclusion criteria (8 listed)
- Patients with a known deleterious mutation in BRCA1 and BRCA2
- Patients do not meet criteria suggestive of a hereditary predisposition
- Persons deprived of liberty or under guardianship (including guardianship)
- Males
- Personal or family history of breast and / or ovarian cancer (breast or ovarian cancer in their family experienced 1st and 2nd degree before age 50 for breast cancer before age 60 for cancer ovarian)
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 collectionblood collection for research quantification of allelic expression in the gene BRCA1. | Genetic | patients group |
| blood collectionblood collection for research quantification of allelic expression in the gene BRCA1. | Genetic | control population |
Primary outcome
estimate the proportion of patients with allelic imbalance at the level of expression of BRCA1
Time frame: blood sample at baseline, no follow-up in this study
The main objective of this study is to estimate the proportion of patients with allelic imbalance at the level of expression of BRCA1 in a population meeting the criteria suggestive of a hereditary predisposition to breast and / or ovarian cancer , and negative for deleterious mutations of BRCA 1 and BRCA 2.
3 secondary outcomes
Study the variability of the measurement of the allelic expression depending on the position of SNPs
Time frame: blood sample at baseline, no follow-up in this study
proportion of patients with allelic imbalance at the level of expression of the BRCA2 gene
Time frame: blood sample at baseline, no follow-up in this study
Observe the possible effect of age
Time frame: blood sample at baseline, no follow-up in this study
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 13 Jul 2012.
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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.
Agnès HARDOUIN, MD principal investigator
Centre François Baclesse
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing blood collection in people with Hereditary Breast and Ovarian Cancer Syndrome, run by Centre Francois Baclesse at 6 sites 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 8 inclusion and 8 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 13 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
estimate the proportion of patients with allelic imbalance at the level of expression of BRCA1 (time frame: blood sample at baseline, no follow-up in this study). 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 13 Jul 2012.