PiMZ Longitudinal Cohort (PiMZ Logic)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorColumbia University
About this trial
Alpha-1 Anti-trypsin Deficiency (AATD) is a genetic disease with lung and liver disease presentations. Presentations are variable in the heterozygous population, the most predominant genotype being PiMZ. The purpose of this study in PiMZ heterozygous patients is to examine the density of the lung as measured by chest computed tomography (CT) and determine if existing emphysema predicts changes in the rate of subsequent emphysema or changes in CT, serum or plasma biomarkers of interest. The overarching goal is to develop biomarkers pertinent to the PiMZ patient that can be used in interventional trials since lung function changes do not typically inform disease progression in AATD.
Eligibility criteria
Qualifiers
Males and females aged 18 years and older
Understand the study procedures, risks, benefits, purpose
Able and willing to comply with the study procedures
Have PiMZ alpha-1 antitrypsin deficiency
Disqualifiers
AATD non-PiMZ status, including carriers
Current lung, hematologic, or solid organ malignancy other than skin or cervical Stage 1 cancers within the past 3 years
COPD exacerbation or other pulmonary infection within 6 weeks of baseline visit
Pregnancy at the time of the screening visit
Trial design
Treatments tested in this trial
- Not listed
Trial groups
80 Participants
are grouped into 1 trial groupSponsors and collaborators
Columbia University
Lead sponsor
Alpha-1 Foundation
Collaborator
Source ClinicalTrials.gov