Evaluation of the Intrinsic Hepcidin IDx™ Test to Detect Iron Deficiency and Predict Response to Oral Iron Therapy in Adolescents and Young Adults
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 494
- 试验地点
- 1
- 主要终点
- Diagnostic accuracy of the Intrinsic Hepcidin IDx test
研究概览
简要总结
This is a single center, prospective, observational study to demonstrate the clinical validity of the Intrinsic LifeSciences (ILS) Intrinsic Hepcidin IDx™ Test in the diagnosis and management of iron deficiency (ID) in adolescents and young adults. This test is considered non-significant risk.
详细描述
This observational study is composed of two phases, and no investigational intervention agent. Oral iron therapy will be recommended by each subject's primary care clinician or his/her designate according to standard clinical care. There is no randomization. Subjects will be screened for enrollment by study personnel.
Diagnostic Testing Phase (Study Visit 1). Enrolled subjects will have a study blood draw. Enrolled subjects will be assessed for presence of ID as defined by the reference standard: ID: Ferritin < 20 ng/mL.
Enrolled subjects will be assessed for presence of anemia as defined by: Anemia - Hemoglobin ≤ 11 g/dL
Those determined to have ID and/or anemia and are prescribed oral iron therapy by their clinician will continue to the next phase in the study. For those without ID or anemia, or who meet Observation of Treatment Phase exclusion criteria, study participation will be complete. The expected duration of subject involvement for the Diagnostic Testing Phase is 1 week.
Observation of Treatment Phase (Study Visits 2 and 3). Subjects identified as having ID and/or anemia and who have been prescribed oral iron therapy by their physician according to standard of care, and do not meet Observation of Treatment Phase exclusion criteria, will continue to the Observation of Treatment Phase of the study.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 11 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age at least 11 years
- •Subjects must give informed assent/ consent prior to the blood draw. Subjects that are minors (<18 years) must have a parent or guardian give informed consent and the subject must give assent to participate in the study.
- •Willing to comply with all oral iron supplementation and follow up visits if they move to the Observation of Treatment Phase.
- •Able to communicate in English.
排除标准
- •Acute febrile illness (Temp ≥100.4°F (38°C), or acute otitis media, gastroenteritis, pharyngitis or other URI, within the previous one week.
- •History of known hemoglobinopathy (e.g., thalassemia trait or sickle cell)
- •Any parenteral iron received in the 30 days prior to enrollment.
- •Presently taking oral iron supplements (except for iron as part of multivitamin or oral contraceptive pill) or has taken it in the 30 days prior to enrollment.
- •An allergy or hypersensitivity to oral iron sulfate.
- •Has received a blood transfusion in the 90 days prior to enrollment.
- •Any investigational drug use in the 30 days prior to enrollment.
- •Any known malignancy.
- •Receiving dialysis.
- •Known to be pregnant or currently breast-feeding.
- •Any lab abnormality, medical condition, or psychiatric disorder which in the opinion of the investigator would put the subject's disease management at risk or may result in the subject being unable to comply with study requirements.
结局指标
主要结局
Diagnostic accuracy of the Intrinsic Hepcidin IDx test
时间窗: 12 weeks
To demonstrate the diagnostic accuracy of the Intrinsic Hepcidin IDx TestTM to diagnose ID in adolescents and young adults, where diagnostic accuracy is defined by the lower 95% confidence interval on sensitivity (Se) being not less than 70% and the lower 95% confidence interval on specificity (Sp) not being less than 70%.
次要结局
- Prediction of Response to Oral Iron Therapy(12 weeks)
- Predict Therapeutic Response to Oral Iron Therapy(12 weeks)