CancerPSICOMNCT03889171
Comparison to Psychological, Medical and Emotional Influencing Communication and Achievement Factors to Oncogenetics Tests
An observational study of Cancer and Colorectal Cancer, run by University Hospital, Montpellier.
Trial summary
The purpose of the study was to analyze the psychological and emotional determinants of domestic dissemination of information about genetic risk of cancer and to compare the level of diffusion syndromes in breast/ ovarian cancer ( BRCA1 / BRCA2) and colon/endometrial ( HNPCC ) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Colorectal Cancer, Breast Cancer
- What is being tested?
- Behaviour
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- Aug 2012to Sep 2018
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: female and male participants are being studied
Who may be able to join
- Patient having a deleterious genetic mutation on genes BRCA1 and/or BRCA2 and or on genes MMR
- The patient being of the family (who carried out a full analysis of BRCA1/BRCA2 and/or those MMR )
Who cannot join
- Patient not carrying a deleterious genetic mutation on the BRCA1/2 genes and/or those of the MMR system,
- Patient under guardianship, curator or unable to give his non-opposition,
- Adult patients protected by law.
About this study
Official title: Predisposition to Breast Cancer BRCA1 / BRCA2 and to HNPCC Colon : Comparison to Psychological, Medical and Emotional Influencing Communication and Achievement Factors to Oncogenetics Tests
The purpose of the study was to analyze the psychological and emotional determinants of domestic dissemination of information about genetic risk of cancer and to compare the level of diffusion syndromes in breast/ ovarian cancer ( BRCA1 / BRCA2) and colon/endometrial ( HNPCC )
Read the detailed description
The risk associated with a genetic predisposition is among the various forms of risk, the strongest identifiable risk . It enables to offer people at risk an appropriate medical care (screening, prevention ) the clinical benefit is validated today. The person with whom a predisposing mutation has been identified must communicated its related information on the risk of cancer and the ability to perform genetic analysis. It appears that this dissemination of information is not always optimal, as shown in figures from the National Cancer Institute joined the project; the purpose of the study was to analyze the psychological and emotional determinants of domestic dissemination of information about genetic risk of cancer and to compare the level of diffusion syndromes in breast/ ovarian cancer ( BRCA1 / BRCA2) and colon/endometrial ( HNPCC )
- Conditions
- Cancer, Colorectal Cancer, Breast Cancer, Ovarian Cancer
- Being tested
- Behaviour
- Keywords
- genetic testing, genes BRCA1, genes BRCA2, mutation, family, disclosure, psychology, DNA mismatch repair, genetic predisposition to disease, cancer, oncology
- Medical subject headings
- Neoplasms, Colorectal Neoplasms, Breast Neoplasms, Ovarian Neoplasms, Fanconi Anemia, Complementation Group D1, Genetic Predisposition to Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BehaviourBehavioural
Comparison to psychological, medical and emotional Influencing communication and achievement factors to Oncogenetics tests
What is being measured
The primary outcome is the main question the study is designed to answer.
intrafamilial disclosure rate
The intrafamilial disclosure rate assessed the number of relatives informed by the proband about the mutation (according to the proband) out of the number of relatives at risk of carrying the familial mutation. Relatives who were considered "at risk" were first, second, third or fourth-degree relatives, older than 18 years and related to the relevant side of the family or, if unknown, just related to the proband whatever the family side.
Measured: On average 1 year
relatives' genetic targeted testing uptake rate
The relatives' genetic targeted testing uptake rate assessed the number of relatives considered by the proband to have taken up the genetic targeted testing out of the number of relatives informed by the proband. To assess the potential bias of the proband's perception of genetic targeted testing uptake by relatives, we compared the number of relatives who underwent genetic targeted testing according to the proband with the number of tests actually performed. This anonymous comparison was performed in a subset of the population within the geographic regional area of Montpellier where all analyses are centralized in a single laboratory. Probands were asked how many relatives living in the region underwent genetic testing and this number was compared with the information available from the University Laboratory of Montpellier.
Measured: On average 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2019
- Study startAug 2012
- Primary completionSep 2014
- Study completionSep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03889171
- Sponsor's protocol ID
- 8893
- Acronym
- PSICOM
- Status last verified
- Mar 2019
- First submitted
- 11 Mar 2019
- Last updated
- 28 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predisposition to Breast Cancer BRCA1 / BRCA2 and to HNPCC Colon : Comparison to Psychological, Medical and Emotional Influencing Communication and Achievement Factors to Oncogenetics Tests
- ClinicalTrials.gov ID
- NCT03889171
- Acronym / sponsor ID
- PSICOM / 8893
- Conditions
- Cancer, Colorectal Cancer, Breast Cancer, Ovarian Cancer
- Keywords
- genetic testing, genes BRCA1, genes BRCA2, mutation, family, disclosure, psychology, DNA mismatch repair
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- Aug 2012 (actual)
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2018 (actual)
- First posted
- 26 Mar 2019 (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 purpose of the study was to analyze the psychological and emotional determinants of domestic dissemination of information about genetic risk of cancer and to compare the level of diffusion syndromes in breast/ ovarian cancer ( BRCA1 / BRCA2) and colon/endometrial ( HNPCC )
Detailed description
The risk associated with a genetic predisposition is among the various forms of risk, the strongest identifiable risk . It enables to offer people at risk an appropriate medical care (screening, prevention ) the clinical benefit is validated today. The person with whom a predisposing mutation has been identified must communicated its related information on the risk of cancer and the ability to perform genetic analysis. It appears that this dissemination of information is not always optimal, as shown in figures from the National Cancer Institute joined the project; the purpose of the study was to analyze the psychological and emotional determinants of domestic dissemination of information about genetic risk of cancer and to compare the level of diffusion syndromes in breast/ ovarian cancer ( BRCA1 / BRCA2) and colon/endometrial ( HNPCC )
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- female and male participants are being studied
Key inclusion criteria (2 listed)
- Patient having a deleterious genetic mutation on genes BRCA1 and/or BRCA2 and or on genes MMR
- The patient being of the family (who carried out a full analysis of BRCA1/BRCA2 and/or those MMR )
Key exclusion criteria (3 listed)
- Patient not carrying a deleterious genetic mutation on the BRCA1/2 genes and/or those of the MMR system,
- Patient under guardianship, curator or unable to give his non-opposition,
- Adult patients 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 |
|---|---|---|
| BehaviourComparison to psychological, medical and emotional Influencing communication and achievement factors to Oncogenetics tests | Behavioural | – |
Primary outcome
intrafamilial disclosure rate
Time frame: On average 1 year
The intrafamilial disclosure rate assessed the number of relatives informed by the proband about the mutation (according to the proband) out of the number of relatives at risk of carrying the familial mutation. Relatives who were considered "at risk" were first, second, third or fourth-degree relatives, older than 18 years and related to the relevant side of the family or, if unknown, just related to the proband whatever the family side.
relatives' genetic targeted testing uptake rate
Time frame: On average 1 year
The relatives' genetic targeted testing uptake rate assessed the number of relatives considered by the proband to have taken up the genetic targeted testing out of the number of relatives informed by the proband. To assess the potential bias of the proband's perception of genetic targeted testing uptake by relatives, we compared the number of relatives who underwent genetic targeted testing according to the proband with the number of tests actually performed. This anonymous comparison was performed in a subset of the population within the geographic regional area of Montpellier where all analyses are centralized in a single laboratory. Probands were asked how many relatives living in the region underwent genetic testing and this number was compared with the information available from the University Laboratory of Montpellier.
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 28 Mar 2019.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer and Colorectal Cancer, run by University Hospital, Montpellier.
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 2 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: finished, as of the sponsor's last update on 28 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
intrafamilial disclosure rate (time frame: On average 1 year). 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 28 Mar 2019.