Correlation Between Haptoglobin Phenotypes and Infectious and Other Complications in Cystic Fibrosis Patients

Cystic Fibrosis Clinical Trial

— Hp-in-CF  

Official title:

Correlation Between Haptoglobin Phenotypes and Infectious and Other Complications in Cystic Fibrosis Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01806025
• Other study ID #: CMC-12-0093-CTIL
• Status: Completed
• Phase: N/A
• First received: March 5, 2013
• Last updated: July 27, 2016
• Start date: April 2013
• Est. completion date: January 2015

Study information

• Verified date: July 2016
• Source: Carmel Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ethics Commission
• Study type: Observational

Clinical Trial 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.

Description:

Cystic Fibrosis is a genetic disease with variable severity, and a predisposition for lung infection. The severity of the disease is determined by genetic factors (type of mutation), environmental factors (exposure to bacteria) and behavioral (adherence with therapy). Even among patients with the same severity of mutations there is a variation of the severity of CF.

Haptoglobin is a protein responsible for collecting Iron from senescent Red Blood Cells. There are two genes of Haptoglobin, numbered 1 and 2, and combinations between the two genes create three forms of proteins: 1-1, 1-2, and 2-2. The 1-1 Phenotype was found to be associated with a predisposition to infection.

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 by gel- electrophoresis. The investigators will correlate Haptoglobin phenotype to retrospectively gathered data on infectious complications.

FEV1- Forced Expiratory Volume in 1 second.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 142
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 60 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Cystic Fibrosis
• Fibrosis

Intervention

Other:
• no intervention

Locations

Country	Name	City	State
Israel	Carmel Medical Center	Haifa

Sponsors (1)

Lead Sponsor	Collaborator
Carmel Medical Center

Country where clinical trial is conducted

Israel, 

References & 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/s00408-015-980 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Haptoglobin phenotype	Haptoglobin phenotype in serum will be determined by gel electrophoresis	one visit	No
Primary	FEV1	Lung function as determined by spirometry FEV1 (% expected), normalized by age	best in last 6 months	No
Secondary	Number of antibiotic courses per year of follow up	number of courses of antibiotics the patient received in the last year	one year	No
Secondary	Number of days with antibiotics per year of follow up	number of days the patient received antibiotics	one year	No
Secondary	Number Hospitalizations per year	events of hospitalization	one year	No
Secondary	Colonization with bacteria	colonization of the following bacteria: Pseudomonas aeruginosa (mucoid and non mucoid), Staph aureus (MSSA and MRSA), Hemophilus influenza, Burkholderia Cepacia complex	one year	No
Secondary	Presence of CF related diabetes	presence of CF related diabetes and HbA1C for diabetic patients.	five years	No