Recruiting

Immune Deficiency

Sponsor:

University of Colorado, Denver

Code:

NCT03707782

Conditions

Immune Deficiency

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Study Details

Brief summary:

1. The purpose of this study is to learn more about the changes in genes, cells and proteins that cause immune deficiency diseases.
2. The early stages of the study will focus on two groups of patients:

1. members of families in which several persons have symptoms or medical histories that suggest immune deficiency.
2. Patients who have received treatments with medications or drugs that affect functions of the immune system (secondary immune deficiencies).

It is hoped that studies will provide guidelines for extension of the research to other patient groups. Up to 200 patients and family members will be invited to participate.

Conditions

Immune Deficiency

Study ID

NCT03707782

Start date

Oct 20, 2020

Status verified date

Apr, 2022

Completion date

Dec, 2023

Anticipated

Primary completion date

Dec, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Immunodeficiency disease; or
2. family member of individual with immunodeficiency disease

Exclusion Criteria:

1. Persons with immune deficiencies that are secondary to other diseases such as malignancies.
2. Persons who do not have immune deficiencies, persons who are not meet eligibility criteria

Study Design

Enrollment

200 participants

Anticipated

Interventions and Outcome Measures

Arms

Individuals with immune deficiencies

aged 18 years or older and have an immune deficiency

Family members

aged 18 years or older and are related to a person who has an immune deficiency

Primary outcome measure

  • Measurement of Serum immune globulin [ Time Frame: each year for up to 20 years ]
  • Antibody responses [ Time Frame: 4 weeks ]
  • Measurement of NK cell function [ Time Frame: one time ]
  • DNA sequencing [ Time Frame: one time ]
  • measurement of cellular components of the immune system [ Time Frame: each year for up to 20 years ]
  • health outcome measurements [ Time Frame: each year for up to 20 years ]
  • Measurement of avidity [ Time Frame: each year for up to 20 years ]

Central Contacts and Locations

Central contacts

Charles Kirkpatrick

(303) 724-7197charles.kirkpatrick@ucdenver.edu

Locations

UColorado

Recruiting

Denver, Colorado, United States, 80045

Contacts

Charles H Kirkpatrick, MD

303-724-7197charles.kirkparick@ucdenver.edu

More Information

Sponsor

University of Colorado, Denver

Last update posted

Apr 19, 2022

Last verified

Apr, 2022

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Colorado, Denver on 2022-04-19.