BRCA1 MutationNCT03211611
Management of Women With BRCA1/2 Mutation
An observational study of BRCA1 Mutation and BRCA2 Mutation, run by University Hospital, Montpellier at 1 site in France.
Trial summary
The aim of this study is to determine general practitionners' role in management of women with BRCA1/2 mutation. This study will be conduct between April 2017 and December 2017 at Montpellier University Hospital on women followed-up in the department of genetics and their general practitionners (GP). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- BRCA1 Mutation, BRCA2 Mutation
- What is being tested?
- Questionnaire given to the two groups
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 600 participants
- Where
- 1 siteFrance
- Study dates
- 1 Apr 2017to 1 Nov 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' group: women with BRCA 1 / 2 mutation followed-up in the department of genetics at Montpellier University Hospital. GP group: GP of women included in patients' group.
Who may be able to join
- Aged over 18
- Women
- Living in France
- Having a medical insurance
Who cannot join
- Men
- Dementia
- Non frenchspeaker
- Mental retardation
- Being the subject of a guardianship or tutelage measure
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Role of General Practionners in Management of Women With BRCA1/2 Mutation
The aim of this study is to determine general practitionners' role in management of women with BRCA1/2 mutation.
This study will be conduct between April 2017 and December 2017 at Montpellier University Hospital on women followed-up in the department of genetics and their general practitionners (GP). Patients and their GP will be called by the investigators and questionnaire will be given to them. Questionnaire includes questions for patients and their GP. The primary endpoint was to determine the rate of GP having sufficient knowledge of the adequate management of patients with BRCA1 / 2 mutation. Adequate knowledge includes : systematic search for a family history of cancer, knowing criteria required to refer women in oncogenetic department, and the ability to respond to patients' questions. Secondary endpoint was to determine women' opinion on their GP : whether or not well managed for their BRCA 1 / 2 mutation.
Read the detailed description
PURPOSE: The aim of this study is to determine general practitionners' role in management of women with BRCA1/2 mutation.
METHODS:
This study will be conduct between April 2017 and December 2017 at Montpellier University Hospital on women followed-up in the department of genetics and their general practitionners (GP). Patients and their GP will be called by the investigators and questionnaire will be given to them. Questionnaire includes questions for patients and their GP. The primary endpoint was to determine the rate of GP having sufficient knowledge of the adequate management of patients with BRCA1 / 2 mutation. Adequate knowledge includes : systematic search for a family history of cancer, knowing criteria required to refer women in oncogenetic department, and the ability to respond to patients' questions. Secondary endpoint was to determine women' opinion on their GP : whether or not well managed for their BRCA 1 / 2 mutation.
- Conditions
- BRCA1 Mutation, BRCA2 Mutation
- Being tested
- Questionnaire given to the two groups
- Keywords
- BRCA1/2 Mutation, Breast cancer, General practitionner
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Questionnaire given to the two groupsBehavioural
Questionnaire given to the two groups :
Patients with BRCA ½ mutation GP
| Study group | Role | What they receive |
|---|---|---|
| Patients with BRCA ½ mutation | Women with BRCA 1 / 2 mutation with or without cancer Age over 18 Receives: Behavioral: Questionnaire given to the two groups | |
| GP | GP of the patients with BRCA 1 / 2 mutation Receives: Behavioral: Questionnaire given to the two groups |
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of GP having sufficient knowledge of the adequate management of patients with BRCA1 / 2 mutation.
Adequate knowledge includes : systematic search for a family history of cancer, knowing criteria required to refer women in oncogenetic department, and the ability to respond to patients' questions
Measured: 1 day
Secondary outcomes (1)
Women' opinion on their GP
Women' opinion on their GP : whether or not well managed for their BRCA 1 / 2 mutation.
The rate of GP wanting a formation in oncogenetic
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2017
- Study start1 Apr 2017
- Primary completion31 Aug 2017
- Study completion1 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BRCA1 MutationStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 600 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pascal PUJOL, PR, Study chair, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03211611
- Sponsor's protocol ID
- RECHMPL17_0200
- Status last verified
- Jul 2017
- First submitted
- 6 Jul 2017
- Last updated
- 7 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: NC
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of General Practionners in Management of Women With BRCA1/2 Mutation
- ClinicalTrials.gov ID
- NCT03211611
- Acronym / sponsor ID
- RECHMPL17_0200
- Conditions
- BRCA1 Mutation, BRCA2 Mutation
- Keywords
- BRCA1/2 Mutation, Breast cancer, General practitionner
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 600 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 1 Apr 2017 (actual)
- Primary completion
- 31 Aug 2017 (actual)
- Study completion
- 1 Nov 2017 (actual)
- First posted
- 7 Jul 2017 (actual)
- 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 aim of this study is to determine general practitionners' role in management of women with BRCA1/2 mutation.
This study will be conduct between April 2017 and December 2017 at Montpellier University Hospital on women followed-up in the department of genetics and their general practitionners (GP). Patients and their GP will be called by the investigators and questionnaire will be given to them. Questionnaire includes questions for patients and their GP. The primary endpoint was to determine the rate of GP having sufficient knowledge of the adequate management of patients with BRCA1 / 2 mutation. Adequate knowledge includes : systematic search for a family history of cancer, knowing criteria required to refer women in oncogenetic department, and the ability to respond to patients' questions. Secondary endpoint was to determine women' opinion on their GP : whether or not well managed for their BRCA 1 / 2 mutation.
Detailed description
PURPOSE: The aim of this study is to determine general practitionners' role in management of women with BRCA1/2 mutation.
METHODS:
This study will be conduct between April 2017 and December 2017 at Montpellier University Hospital on women followed-up in the department of genetics and their general practitionners (GP). Patients and their GP will be called by the investigators and questionnaire will be given to them. Questionnaire includes questions for patients and their GP. The primary endpoint was to determine the rate of GP having sufficient knowledge of the adequate management of patients with BRCA1 / 2 mutation. Adequate knowledge includes : systematic search for a family history of cancer, knowing criteria required to refer women in oncogenetic department, and the ability to respond to patients' questions. Secondary endpoint was to determine women' opinion on their GP : whether or not well managed for their BRCA 1 / 2 mutation.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with BRCA ½ mutation | – | Behavioral: Questionnaire given to the two groupsWomen with BRCA 1 / 2 mutation with or without cancer Age over 18 |
| GP | – | Behavioral: Questionnaire given to the two groupsGP of the patients with BRCA 1 / 2 mutation |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients' group: women with BRCA 1 / 2 mutation followed-up in the department of genetics at Montpellier University Hospital. GP group: GP of women included in patients' group.
Key inclusion criteria (4 listed)
- Aged over 18
- Women
- Living in France
- Having a medical insurance
Key exclusion criteria (5 listed)
- Men
- Dementia
- Non frenchspeaker
- Mental retardation
- Being the subject of a guardianship or tutelage measure
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 |
|---|---|---|
| Questionnaire given to the two groupsQuestionnaire given to the two groups : Patients with BRCA ½ mutation GP | Behavioural | GP, Patients with BRCA ½ mutation |
Primary outcome
The rate of GP having sufficient knowledge of the adequate management of patients with BRCA1 / 2 mutation.
Time frame: 1 day
Adequate knowledge includes : systematic search for a family history of cancer, knowing criteria required to refer women in oncogenetic department, and the ability to respond to patients' questions
1 secondary outcome
Women' opinion on their GP
Time frame: 1 day
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 7 May 2018.
- Individual participant dataSharing planned: Undecided. NC
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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, PR study chair
University Hospital, 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 BRCA1 Mutation and BRCA2 Mutation, 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 4 inclusion and 5 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 7 May 2018. 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?
The rate of GP having sufficient knowledge of the adequate management of patients with BRCA1 / 2 mutation. (time frame: 1 day). 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 7 May 2018.