Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:22 PM
Ignite Modification Date:
2025-12-24 @ 7:22 PM
NCT ID:
NCT06213103
Eligibility Criteria:
Inclusion Criteria:
* General inclusion criteria:
* Patient weighing more than 30kg
* Person affiliated with or receiving a social security plan;
* Patient-specific inclusion criteria:
* Patient with molecularly proven primary mitochondrial disease
* Free, informed, written consent signed by parental authority holders for minor patients and the investigator prior to any examination required by the research and oral and/or written assent by the participant (depending on age).
* Free, informed consent signed by the patient's representative for adult patients under guardianship and the investigator prior to any examination required by the research.
* Free, informed consent signed by the patient of legal age and the investigator prior to any examination required by the research
* Specific inclusion criteria for controls:
* Person who has been informed of the purpose of the study and person matched in age (+/- 5 years) and sex to a patient with primary mitochondrial disease at the time of sampling
* Free, informed, and signed consent
* Person with no known mitochondrial disease
Exclusion Criteria:
* Pregnant or breastfeeding women
* Refusal to consent to participate in research,
* Patients for whom molecular causes have not been formally identified (genetic analyses not performed, or no variant or variant of unknown significance after analysis).
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
6 Years
Study:
NCT06213103
Study Brief:
Protocol Section:
NCT06213103