Serum Hepcidin Immunoassay - Laboratory to Marketplace
United States494 participantsStarted 2016-06-30
Plain-language summary
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.
Who can participate
Age range
11 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Diagnostic accuracy of the Intrinsic Hepcidin IDx test