- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03889171
Comparison to Psychological, Medical and Emotional Influencing Communication and Achievement Factors to Oncogenetics Tests (PSICOM)
March 26, 2019 updated by: University Hospital, Montpellier
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 )
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Observational
Enrollment (Actual)
200
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
female and male participants are being studied
Description
Inclusion Criteria:
- 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 )
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
On average 1 year
|
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.
|
On average 1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 1, 2012
Primary Completion (Actual)
September 1, 2014
Study Completion (Actual)
September 1, 2018
Study Registration Dates
First Submitted
March 11, 2019
First Submitted That Met QC Criteria
March 21, 2019
First Posted (Actual)
March 26, 2019
Study Record Updates
Last Update Posted (Actual)
March 28, 2019
Last Update Submitted That Met QC Criteria
March 26, 2019
Last Verified
March 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 8893
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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