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 @ 1:03 PM
Ignite Modification Date:
2025-12-24 @ 1:03 PM
NCT ID:
NCT02451761
Eligibility Criteria:
Inclusion Criteria:
* Abnormal phenotype: intellectual disability and/or multiple congenital anomalies.
* Post-natal cases
* ABCR diagnosed by standard karyotype, including reciprocal translocation, inversion, insertion and Complex Chromosomal Rearrangement (CCR).
* de novo ABCR. Inherited ABCR could be included if the transmitting parent shows also an abnormal phenotype or if the rearrangement involves an imprinted chromosome.
* Array-CGH results normal that mean absence of pathogenic imbalances. Identification of Variant Of Unknown Significance (VOUS) does not prevent from inclusion.
* Information and written consent of patient or his legal representative (information and consent form available on request).
* Covered by a Health System
Exclusion Criteria:
* Pathogenic genomic imbalance demonstrated by array-CGH.
* Identification of an independent etiology (i.e. monogenic disease, environment,…).
* Rejection to participate ton the study
* Weight inferior to 6 kg
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
3 Months
Study:
NCT02451761
Study Brief:
Protocol Section:
NCT02451761