Novel Testing Procedures
The purpose of this study is to evaluate a novel screening test to detect patients with primary immunodeficiencies(PIDs). The investigators plan to use information gained from this study in order to advance the field of clinical immunology, thus improving the diagnosis, treatment, and well-being of future patients. The purpose of this study is to determine if this screening test is able to detect patients with immune problems, and the investigators will test patients with known PIDs to determine if the test is accurate
The investigators hypothesize that detecting serum immunoglobulins from dried blood spots will be effective in detecting patients with known primary immunodeficiencies. If our hypothesis is confirmed, it opens the possibility of using point of care testing to screen for primary immune deficiencies.
Age of study subjects will range from 1 year to 80 years of age, and will be recruited form the Immunodeficiency clinic at the Medical College of Wisconsin/Children's Hospital of Wisconsin (MCW/CHW). Any subject having testing done to evaluate the immune system is eligible for this study. This will include patients with known PIDs as well as patients evaluated for a suspected immunodeficiency. It is anticipated that 150 subjects will be analyzed over a two year period.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Novel Testing Procedures for Detection of Primary Humoral Immunodeficiency|
- Clinically validated diagnostic test for primary humoral immunodeficiency. [ Time Frame: two years ]We will test if measurement of serum immunoglobulin levels from a blood spot on filter paper is able to detect patients with known immunodeficiencies and low Immunoglobulin G levels.
|Study Start Date:||April 2016|
|Estimated Study Completion Date:||June 2017|
|Estimated Primary Completion Date:||September 2016 (Final data collection date for primary outcome measure)|
Any subject having testing done to evaluate the immune system is eligible for this study. This will include patients with known PIDs as well as patients evaluated for a suspected immunodeficiency.
After consent is obtained, blood will be obtained. The total amount of blood to drawn in one day will not exceed 1.5 mL (1/3 tsp) per pound of body weight. All samples will be collected at the same time as routine blood draws as ordered by your physician.
Subject samples will be de-identified by the Principal Investigator (PI) and given a serial number. The PI will retain a secured log of the serial numbers and basic identifiers (name, Date of Birth (DOB0, sex, preliminary diagnosis, and test results), and the subject samples will be stored in a secured freezer. Only the PI will have access to the secured log book. All study test results will be kept on compact discs, or similar computer storage devices, in a secured area that will only be accessible by the PI. Study test results will not kept on computers accessible by other individuals. The samples will not be sold to any third party. The results of this research will not be conveyed to any third party. If the subject withdraws or is withdrawn from the study all identifiable biological samples from that subject will be discarded. The sample will not be available for any other type of testing outside of this study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01793506
|United States, Wisconsin|
|Asthma, Allergy & Immunology Clinics Medical College of Wisconsin|
|Milwaukee, Wisconsin, United States, 53226|
|Principal Investigator:||James Verbsky, MD PhD||Medical College of Wisconsin|
|Principal Investigator:||John Routes, MD||Medical College of Wisconsin|