Novel Testing Procedures

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified August 2013 by Medical College of Wisconsin
Sponsor:
Collaborator:
Baxter Healthcare Corporation
Information provided by (Responsible Party):
Medical College of Wisconsin
ClinicalTrials.gov Identifier:
NCT01793506
First received: February 12, 2013
Last updated: August 22, 2013
Last verified: August 2013
  Purpose

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.


Condition
Immunodeficiencies

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Novel Testing Procedures for Detection of Primary Humoral Immunodeficiency

Further study details as provided by Medical College of Wisconsin:

Primary Outcome Measures:
  • Clinically validated diagnostic test for primary humoral immunodeficiency. [ Time Frame: two years ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 150
Study Start Date: September 2013
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
PID
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.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   1 Year to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Male or female, 1 year to 80 years of age

Criteria

Inclusion Criteria:

  • Any subject having testing done to evaluate the immune system is eligible for this study.

Exclusion Criteria:

  • Inability or unwillingness on the part of the parents or individual to provide clinical or family history, or refusal to allow blood sampling.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01793506

Contacts
Contact: Meribeth Klancnik 414-266-6165 mklancni@mcw.edu

Locations
United States, Wisconsin
Asthma, Allergy & Immunology Clinics Medical College of Wisconsin Not yet recruiting
Milwaukee, Wisconsin, United States, 53226
Principal Investigator: James Verbsky, MD, PhD         
Principal Investigator: John Routes, MD         
Sponsors and Collaborators
Medical College of Wisconsin
Baxter Healthcare Corporation
Investigators
Principal Investigator: James Verbsky, MD PhD Medical College of Wisconsin
Principal Investigator: John Routes, MD Medical College of Wisconsin
  More Information

No publications provided

Responsible Party: Medical College of Wisconsin
ClinicalTrials.gov Identifier: NCT01793506     History of Changes
Other Study ID Numbers: Baxter-01, 01
Study First Received: February 12, 2013
Last Updated: August 22, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Medical College of Wisconsin:
immunodeficiency

Additional relevant MeSH terms:
Immunologic Deficiency Syndromes
Immune System Diseases

ClinicalTrials.gov processed this record on July 20, 2014