Analytical Validation of Circulating DNA Analysis Methods: Creation of a Control Cohort

Institut Claudius Regaud68 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Enrollment

Conditions

Healthy Volunteers (Cancer)

Interventions

1 single blood draw after in the inclusion of the participant in the study (Up to 30 mL).DIAGNOSTIC_TEST

The samples will be processed by the laboratory as follows: - extraction of circulating DNA; - NGS Sequencing on 2 gene-panels; - capillary electrophoresis; - digital PCR

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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)

Locations (1)

Institut Universitaire du Cancer de Toulouse - Oncopole

Toulouse, France

Outcomes

Primary Outcomes

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

Time frame: baseline

Secondary Outcomes

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

Time frame: baseline

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

Time frame: baseline

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

Time frame: baseline

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

Time frame: baseline

Data from ClinicalTrials.gov

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