Healthy Volunteers (Cancer)
Conditions
Keywords
circulating DNA, liquid biopsy
Brief summary
Pilot, prospective, mono-center study conducted in a population of healthy participants (free of cancer) for the analytical validation of circulating DNA analysis methods. The participants are employees of the institution. Their recruitement is carried out via internal posting (intranet and bulletin boards). The study participation will be strictly voluntary and without consequences on the professional situation of the participants.
Interventions
DIAGNOSTIC_TEST1 single blood draw after in the inclusion of the participant in the study (Up to 30 mL).
The samples will be processed by the laboratory as follows: - extraction of circulating DNA; - NGS Sequencing on 2 gene-panels; - capillary electrophoresis; - digital PCR
Sponsors
Institut Claudius Regaud
Sophia Genetics SAS
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 1 Adult volunteer (≥ 18 y.o.) * 2 Participant free of cancer * 3 Participant belonging to the personnel of Oncopole Claudius Regaud (IUCT-O) institution * 4 Participant affiliated to a Social Health Insurance in France * 5 Participant who received clear and understandable information about the research * 6 Participant who signed an informed consent form before inclusion into the study and before any study specific procedure * 7 Participant who accepts a blood draw in the context of the research * 8 Participant who agrees to be contacted in the event of an incidental finding of a potential genetic abnormality
Exclusion criteria
* 1 Participant presenting with an associated pathology potentially preventing the adequate conduct of the study procedure * 2 Participant presenting with a contra-indication to blood draw * 3 Participant who reports to the investigator team * 4 Participant who has forfeited his/her freedom bu administrative or legal award or who is under legal protection (curatorship and guardianship, protection of justice)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of participants for which no pathogenic mutation has been detected on the MSK-Access panel. | baseline | Ratio of number of participants without pathogenic mutation on the MSK-Access panel over the total number of participants |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of participants for wich no pathogenic mutation has been detected on the HRR-Liq panel | baseline | Ratio of number of participants without pathogenic mutation on the HRR-Liq panel over the total number of participants |
| Proportion of participants for wich no pathogenic mutation has been detected on by digital PCR | baseline | Ratio of number of participants without pathogenic mutation via digital PCR panel over the total number of participants |
| Analytical specificity of the estimation of the circulating tumoral fraction: Proportion of participants for which the circulating tumoral fraction is inferior to the detectability threshold | baseline | Ratio of the number of participants for which the circulating tumoral fraction is inferior to the detectability threshold over the total number of participants |
| Analytical specificity of the measurement of circulating DNA fragments' size via electrophoresis: Proportion of participants with an absence of DNA fragments of a size inferior to 150 pb | baseline | Ratio of the number of participants for which there are no DNA fragments of a sieze inferior to 150 pb over the total number of participants |
Countries
France
Outcome results
None listed