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.
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
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)
Single group
1 single blood draw after in the inclusion of the participant in the study (Up to 30 mL).
Diagnostic testThe samples will be processed by the laboratory as follows: - extraction of circulating DNA; - NGS Sequencing on 2 gene-panels; - capillary electrophoresis; - digital PCR
Proportion of participants for which no pathogenic mutation has been detected on the MSK-Access panel.
Ratio of number of participants without pathogenic mutation on the MSK-Access panel over the total number of participants
Proportion of participants for wich no pathogenic mutation has been detected on the HRR-Liq panel
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
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
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
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
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Institut Claudius Regaud
Lead sponsor
Sophia Genetics SAS
Collaborator
