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:
2025-12-26 @ 3:58 PM
Ignite Modification Date:
2025-12-26 @ 3:58 PM
NCT ID:
NCT04511806
Eligibility Criteria:
Inclusion Criteria:
Primary Subjects must meet all of the below criteria to be eligible for enrollment:
1. Be less than 21 years of age at the time of enrollment
2. Have a diagnosis of a specific CPS, whether they have had cancer or not
* Based on clinical laboratory testing demonstrating a Pathogenic or Likely Pathogenic germline variant and/or
* Based on well-established clinical diagnostic criteria and/or
* Based on high clinical suspicion of a specific CPS with clinical laboratory testing demonstrating a variant of uncertain significance (VUS)
Affected Parents must meet all of the following criteria to be eligible for enrollment:
1. Be the biologic parent of a Primary Subject and
2. Carry a diagnosis (or obligate diagnosis) of the familial CPS
Adult Affected Siblings must meet all of the following criteria to be eligible for enrollment:
1. Be the biologic sibling of a Primary Subject and
2. Carry a diagnosis (or obligate diagnosis) of the familial CPS
Unaffected Parents and Siblings must meet all of the following criteria to be eligible for enrollment
1. Be the biologic parent or sibling of a Primary Subject and
2. Not carry a diagnosis (or obligate diagnosis) of the familial CPS
Affected Family Members must meet all of the following criteria to be eligible for enrollment:
1\. Carry a diagnosis of (or obligate diagnosis of) the familial CPS. Documentation is requested but not required.
More than one child from a Primary Family Unit may be a Primary Subject. An Unaffected Sibling may be reclassified as a Primary Subject if diagnosed with a CPS during childhood.
Exclusion Criteria:
* Individuals with a strong personal or family history of cancer without a genetic or clinical diagnosis of a specific CPS are not eligible for enrollment.
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT04511806
Study Brief:
Protocol Section:
NCT04511806