Analytical Validation of Circulating DNA Analysis Methods: Creation of a Control Cohort
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: 1 single blood draw after in the inclusion of the participant in the study (Up to 30 mL)..
- Who it may be relevant to
- Registry conditions: Healthy Volunteers (Cancer). Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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.
Interventions
- 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
Primary outcome measures
- Proportion of participants for which no pathogenic mutation has been detected on the MSK-Access panel. [Time frame: baseline]
Secondary outcome measures (4)
- Proportion of participants for wich no pathogenic mutation has been detected on the HRR-Liq panel [Time frame: baseline]
- Proportion of participants for wich no pathogenic mutation has been detected on by digital PCR [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 [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 [Time frame: baseline]
Eligibility criteria
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Health services research
Study locations
France · 1 center
- Institut Universitaire du Cancer de Toulouse - Oncopole — Toulouse
Identifiers
NCT: NCT07663994 · 26 GENE 13