Analytical Validation of Circulating DNA Analysis Methods: Creation of a Control Cohort (HD-DNA)

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 Overview

• Status: Recruiting
• Conditions: Healthy Volunteers (Cancer)
• Intervention / Treatment: Diagnostic test: 1 single blood draw after in the inclusion of the participant in the study (Up to 30 mL).

• Study Type: Interventional
• Enrollment (Estimated): 68
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Laura KELLER, PhD; Phone Number: 0033 5 31 15 52 14; Email: keller.laura@iuct-oncopole.fr

Study Locations

• France
  • Toulouse, France, 31059
    • Recruiting
    • Institut Universitaire du Cancer de Toulouse - Oncopole
    • Contact: Laura KELLER, PhD; Phone Number: 0033 5 31 15 52 14; Email: keller.laura@iuct-oncopole.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Blood draw for analysis	Diagnostic test: 1 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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	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	baseline

Collaborators and Investigators

• Sponsor: Institut Claudius Regaud
• Collaborators: Sophia Genetics SAS

Study record dates

Study Major Dates

• Study Start (Estimated): June 30, 2026
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2026

Study Registration Dates

• First Submitted: June 12, 2026
• First Submitted That Met QC Criteria: June 17, 2026
• First Posted (Actual): June 23, 2026

Study Record Updates

• Last Update Posted (Actual): June 26, 2026
• Last Update Submitted That Met QC Criteria: June 23, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: liquid biopsy; circulating DNA
• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: 26 GENE 13

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No