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

NCT07663994 | Recruiting

• 1 other identifier: 26 GENE 13
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteers (Cancer)

Keywords

circulating DNA; liquid biopsy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Proportion of participants for wich no pathogenic mutation has been detected on the HRR-Liq panel

  baseline

• Proportion of participants for wich no pathogenic mutation has been detected on by digital PCR

  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

  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

  baseline

Study Arms (1)

Blood draw for analysis

EXPERIMENTAL

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

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

Blood draw for analysis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult volunteer (≥ 18 y.o.)
• Participant free of cancer
• Participant belonging to the personnel of Oncopole Claudius Regaud (IUCT-O) institution
• Participant affiliated to a Social Health Insurance in France
• Participant who received clear and understandable information about the research
• Participant who accepts a blood draw in the context of the research
• Participant who agrees to be contacted in the event of an incidental finding of a potential genetic abnormality

You may not qualify if:

• Participant presenting with an associated pathology potentially preventing the adequate conduct of the study procedure
• Participant presenting with a contra-indication to blood draw
• Participant who reports to the investigator team
• Participant who has forfeited his/her freedom bu administrative or legal award or who is under legal protection (curatorship and guardianship, protection of justice)

Sponsors & Collaborators

• Institut Claudius Regaud: lead
• Sophia Genetics SAS: collaborator

Study Sites (1)

Institut Universitaire du Cancer de Toulouse - Oncopole

Toulouse, 31059, France

RECRUITING

MeSH Terms

Conditions

Neoplasms

Central Study Contacts

Laura KELLER, PhD

CONTACT

0033 5 31 15 52 14; keller.laura@iuct-oncopole.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2026
• First Posted: June 23, 2026
• Study Start: July 16, 2026
• Primary Completion (Estimated): August 17, 2026
• Study Completion (Estimated): August 17, 2026
• Last Updated: July 24, 2026

Record last verified: 2026-07

Locations

FR (1)