NCT00345280

Brief Summary

Cystic fibrosis(CF) is an inherited disease affecting children, adolescents and young adults with dysfunction of secretory glands.It is caused by mutations in the protein-coding gene which function as the cystic fibrosis transmembrane regulator (CFTR), responsible for the secretion of chloride ions in epithelial cells, adenocytes, sweat gland cells, pancreatic ducts,alimentary and respiratory tracts and eye. Assessment of the relationship between the inflammatory processes and apoptosis in the eye in the course of cystic fibrosis will allow determination of immunological exponents which may facilitate diagnosis.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
26

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2006

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 27, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 28, 2006

Completed
1 month until next milestone

Study Start

First participant enrolled

August 1, 2006

Completed
2.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2008

Completed
Last Updated

June 17, 2008

Status Verified

June 1, 2008

First QC Date

June 27, 2006

Last Update Submit

June 16, 2008

Conditions

Keywords

Cystic fibrosiseyeinflammationapoptosisC11+

Interventions

Vitamin A

Also known as: Becton Dickinson

Eligibility Criteria

Age3 Years - 25 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

26 male and female patients aged 3-25 with clinically definite diagnosis of cystic fibrosis

You may qualify if:

  • male and female patients aged 3-25 with clinically definite diagnosis of cystic fibrosis
  • all patients must give written consent for participation in the study at screening

You may not qualify if:

  • patients with a history of chronic disease of the immune system
  • patients with the history of systemic diseases
  • patients with the history chronic ocular diseases
  • patients who have been treated with corticosteroids in the past 3 months prior to the screening visit

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University

Bialystok, 15- 089, Poland

RECRUITING

MeSH Terms

Conditions

Eye ManifestationsCystic FibrosisInflammationLipodystrophy, Congenital Generalized

Condition Hierarchy (Ancestors)

Eye DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsPancreatic DiseasesDigestive System DiseasesLung DiseasesRespiratory Tract DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesInfant, Newborn, DiseasesPathologic ProcessesLipid Metabolism, Inborn ErrorsMetabolism, Inborn ErrorsLipodystrophySkin Diseases, MetabolicSkin DiseasesSkin and Connective Tissue DiseasesLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Malgorzata Mrugacz, MD, PhD

    Department of Pediatric Ophthalmology Medical University of Bialystok, Poland

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Michal Sewerynski, Prof.

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

June 27, 2006

First Posted

June 28, 2006

Study Start

August 1, 2006

Study Completion

September 1, 2008

Last Updated

June 17, 2008

Record last verified: 2008-06

Locations