Novel Testing Procedures

NCT01793506 | Withdrawn

• 2 other identifiers: Baxter-0101
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Immunodeficiencies

Keywords

immunodeficiency

Outcome Measures

Primary Outcomes (1)

• Clinically validated diagnostic test for primary humoral immunodeficiency.

  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.

  two years

Study Arms (1)

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.

Eligibility Criteria

• Age: 1 Year - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Male or female, 1 year to 80 years of age

You may qualify if:

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

You may not qualify if:

• Inability or unwillingness on the part of the parents or individual to provide clinical or family history, or refusal to allow blood sampling.

Sponsors & Collaborators

• Medical College of Wisconsin: lead
• Baxter Healthcare Corporation: collaborator

Study Sites (1)

Asthma, Allergy & Immunology Clinics Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

MeSH Terms

Conditions

Immunologic Deficiency Syndromes

Condition Hierarchy (Ancestors)

Immune System Diseases

Study Officials

• James Verbsky, MD PhD

  Medical College of Wisconsin

  PRINCIPAL INVESTIGATOR

• John Routes, MD

  Medical College of Wisconsin

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: February 12, 2013
• First Posted: February 15, 2013
• Study Start: April 1, 2016
• Primary Completion: September 1, 2016
• Study Completion: June 1, 2017
• Last Updated: January 30, 2017

Record last verified: 2016-01

Locations

US (1)