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NCT Number: NCT07663994

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

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.

Recruiting

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Key information

Conditions

Healthy Volunteers (Cancer) Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institut Universitaire du Cancer de Toulouse - Oncopole

Toulouse, 31059, France

Location status: Recruiting

Location contact

Laura KELLER, PhD

CONTACT

[email protected]

0033 5 31 15 52 14

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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

Primary outcomes

  1. Proportion of participants for which no pathogenic mutation has been detected on the MSK-Access panel.

    Time frame: baseline

    Ratio of number of participants without pathogenic mutation on the MSK-Access panel over the total number of participants

Secondary outcomes

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

    Time frame: baseline

    Ratio of number of participants without pathogenic mutation on the HRR-Liq panel over the total number of participants

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

    Time frame: baseline

    Ratio of number of participants without pathogenic mutation via digital PCR panel over the total number of participants

  3. 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

    Time frame: 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

  4. 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

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Laura KELLER, PhD

CONTACT

[email protected]

0033 5 31 15 52 14

Sponsors and collaborators

Lead sponsor

Institut Claudius Regaud

Other

Collaborators

  • Sophia Genetics SAS

Registry information

Acronym: HD-DNA

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jun 23, 2026
Registry last updated
Jul 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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