Serum Hepcidin Immunoassay - Laboratory to Marketplace

NCT03310736 | Completed DMC

• 1 other identifier: ILS-0001
• Study Type: observational
• Target: 494
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Anemia, Iron Deficiency

Keywords

iron deficiency; anemia; hepcidin

Outcome Measures

Primary Outcomes (1)

• Diagnostic accuracy of the Intrinsic Hepcidin IDx test

  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%.

  12 weeks

Secondary Outcomes (2)

• Prediction of Response to Oral Iron Therapy

  12 weeks

• Predict Therapeutic Response to Oral Iron Therapy

  12 weeks

Interventions

Intrinsic Hepcidin IDx™ Test DIAGNOSTIC_TEST

ILS scientists developed the bioanalytical method for quantitation of human serum hepcidin using a Beckman FX automated liquid handling platform. The method uses a competitive ELISA format that has a proprietary sensitive and specific monoclonal antibody to hepcidin that captures native hepcidin in a sample. During the reaction a competition between a synthetic, bioactive, biotinylated hepcidin tracer and native hepcidin occurs. Bound biotinylated tracer is detected with a streptavidin-HRP conjugate and TMB substrate. Quantitation is based on an eight-point standard curve using validated, synthetic hepcidin calibrators. The standard curve and the hepcidin concentrations of patients samples are calculated using 4-parameter logistic curve fitting (Prism; Graphpad, Inc., La Jolla, CA). Serum hepcidin concentrations are expressed in ng/ml serum.

Eligibility Criteria

• Age: 11 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The primary care clinic at Boston Children's Hospital (BCH) Adolescent/Young Adult (AYA) Clinic, BCH Sports Medicine Clinic, or at Boston Children's Physicians Weymouth

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Intrinsic LifeSciences, LLC: lead
• Boston Children's Hospital: collaborator

Study Sites (1)

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Any remaining blood, serum or plasma specimens will be stored in a deidentified fashion in an annotated repository at IntrinsicDX for future research on ID and anemia to be conducted by the participating investigators. The key to the deidentified specimens will be held at BCH and will not be shared with the sponsor. After the primary study has been published, the data will be anonymized by destroying any deidentifier keys.

MeSH Terms

Conditions

Anemia, Iron-Deficiency; Iron Deficiencies; Anemia

Condition Hierarchy (Ancestors)

Anemia, Hypochromic; Hematologic Diseases; Hemic and Lymphatic Diseases; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Matthew M Heeney, MD

  Physician

  PRINCIPAL INVESTIGATOR

• Lydia A Shrier, MD, MPH

  Physician

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 10, 2017
• First Posted: October 16, 2017
• Study Start: June 30, 2016
• Primary Completion: December 31, 2018
• Study Completion: February 28, 2019
• Last Updated: June 18, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)