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 @ 7:48 PM
Ignite Modification Date:
2025-12-24 @ 7:48 PM
NCT ID:
NCT03709303
Eligibility Criteria:
* INCLUSION CRITERIA:
Our inclusion criteria for study subjects are:
* Adult (18+ years and older)
* Sickle cell disease patients who are enrolled in at least one of the following sickle cell disease protocols at the National Institutes of Health, National Heart, Lung, and Blood Disease:
* Screening study: 08-H-0156
* Natural history protocol: 04-H-0161
* PBSCT: 09-H-0225, 17-H-0069, 14-H-0077, 03-H-0170
* GT: 14-H-0155
* Have made a decision regarding participation in one of the GT or PBSCT protocols (e.g. someone could still be enrolled in Screening study, have made a decision, but not yet enrolled in or have declined enrollment in the GT or PBSCT studies)
* Study subjects will be recruited in two groups: 1) pre-transplant or pre-initiation of gene therapy, including both those who decide to enroll and those who declined to enroll; and 2) post-transplantation or post-GT, including those who had an unsuccessful and those who had a successful transplantation or response to GT.
EXCLUSION CRITERIA:
Study subjects will be excluded if they:
* Lack cognitive capacity
* Are not English speaking
* Have not made a decision about participation in one of the GT or PBSCT protocols for which they are eligible
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03709303
Study Brief:
Protocol Section:
NCT03709303