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 @ 11:58 PM
Ignite Modification Date:
2025-12-24 @ 11:58 PM
NCT ID:
NCT05506358
Eligibility Criteria:
Inclusion Criteria:
Since the techniques evaluated in the study aims at detecting sickle cell disease (SCD), sickle cell trait (SCT), and β- thalassemia, the following number of participants will be included in Nepal:
* 20 individuals with SCD (HbSS)
* 20 individuals with SCT (HbAS)
* 20 individuals with sickle cell/β-thalassemia compound heterozygous form (HbS/β-thalassemia)
* 20 individuals with β-thalassemia (Hbβ/β-thalassemia)
* 20 individuals with β-thalassemia trait or carrier form (HbA/β- thalassemia)
* 20 healthy individual participants or normal participants (HbAA, participants without any known hemoglobin disorders, such as SCD, SCT or β-thalassemia)
The following number of participants will be included in Canada:
* 30 individuals with SCD (HbSS)
* 30 individuals with SCT (HbAS)
* 30 healthy individual participants or normal participants (HbAA, participants without any known hemoglobin disorders, such as SCD, SCT or β-thalassemia)
Participants older than 1 year of age at the time of drawing blood will be eligible. Signed and dated consent or assent forms will be required by the participants or their parents/guardians.
Exclusion Criteria:
The exclusion criteria for the study:
* Transfusion within the last 3 months
* Pregnancy Participants who wish to withdraw from the study will also be excluded.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
1 Year
Study:
NCT05506358
Study Brief:
Protocol Section:
NCT05506358