Correlation Between Haptoglobin Phenotypes and Infectious and Other Complications in Cystic Fibrosis Patients
Hp-in-CF
1 other identifier
observational
142
1 country
1
Brief Summary
Cystic Fibrosis is a genetic disease with variable severity, and a predisposition for lung infection. Usually severity is determined by the class of CF mutations, but even among patients with the same severity of mutations there is a variation of the severity of CF. Haptoglobin has several types (phenotypes), one of them was found to be related to infectious complications. In this study the investigators aim to find a correlation between Haptoglobin phenotypes in patients with CF and frequency of infectious complications. To this end the investigators will collect serum from CF patients, and determine their Haptoglobin protein phenotype. The investigators will correlate Haptoglobin phenotype to retrospectively gathered data on infectious complications.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Apr 2013
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 5, 2013
CompletedFirst Posted
Study publicly available on registry
March 7, 2013
CompletedStudy Start
First participant enrolled
April 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2015
CompletedJuly 28, 2016
July 1, 2016
1.8 years
March 5, 2013
July 27, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
FEV1
Lung function as determined by spirometry FEV1 (% expected), normalized by age
best in last 6 months
Secondary Outcomes (5)
Number of antibiotic courses per year of follow up
one year
Number of days with antibiotics per year of follow up
one year
Number Hospitalizations per year
one year
Colonization with bacteria
one year
Presence of CF related diabetes
five years
Other Outcomes (1)
Haptoglobin phenotype
one visit
Study Arms (1)
Cystic Fibrosis Patients
Patients with Cystic Fibrosis with two known severe (class I and class II) mutations
Interventions
Eligibility Criteria
Patients diagnosed with CF
You may qualify if:
- Patients diagnosed with CF according to diagnostic criteria , between the ages of 0 and 50, who are themselves, or their parents or guardians, able to give informed consent.
- Two known severe (class I , II and III) mutations
You may not qualify if:
- none
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Carmel Medical Center
Haifa, Israel, 3436209, Israel
Related Publications (1)
Shteinberg M, Rivlin J, Gur M, Konopnicki M, Stein N, Tunney MM, Elborn JS, Downey DG, Johnston E, Shalom H, Levy A. Lack of Association Between Haptoglobin Phenotype and Cystic Fibrosis Outcomes. Lung. 2015 Dec;193(6):1017-21. doi: 10.1007/s00408-015-9801-z. Epub 2015 Sep 14.
PMID: 26370551RESULT
Biospecimen
Peripheral blood serum
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Michal Shteinberg, MD
Pulmonology Institute and CF Center, Carmel Medical Center
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Pulmonology Consultant
Study Record Dates
First Submitted
March 5, 2013
First Posted
March 7, 2013
Study Start
April 1, 2013
Primary Completion
January 1, 2015
Study Completion
January 1, 2015
Last Updated
July 28, 2016
Record last verified: 2016-07
Data Sharing
- IPD Sharing
- Will not share