Eye ManifestationsNCT00345280
Ocular Surface Changes in Patients With Cystic Fibrosis
An observational study of Eye Manifestations, run by University of Bialystok at 1 site in Poland.
Trial 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… Read more about this study
- Who is it for?
- Ages 3 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Eye Manifestations
- What is being tested?
- impression cytology, obtain the tear fluid
- Type of treatment
- Surgery or procedure
- How many people
- 26 participants
- Where
- 1 sitePoland
- Study dates
- Aug 2006to Sep 2008
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 25 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: 26 male and female patients aged 3-25 with clinically definite diagnosis of cystic fibrosis
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Poland1 site, 1 recruiting
- Recruiting
Medical University
Bialystok, 15- 089
Andruszkiewicz, dzialnauki@amb.edu.pl
About this study
Official title: Chosen Parameters of the Immune Response in the Origin of Ocular Changes in Patients With Cystic Fibrosis
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.
Read the detailed description
The aim: To assess the role of chosen parameters of immunological response in the induction of ocular changes in cystic fibrosis patients, particularly chosen chemokine concentrations in the tear fluid and analysis of chosen apoptotic markers expression on conjunctival epithelial cells.
- Conditions
- Eye Manifestations
- Being tested
- impression cytology, obtain the tear fluid
- Keywords
- Cystic fibrosis, eye, inflammation, apoptosis, C11+
- Medical subject headings
- Eye Manifestations, Cystic Fibrosis, Inflammation, Lipodystrophy, Congenital Generalized
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
impression cytology, obtain the tear fluidProcedure or surgery
Also called Becton Dickinson
Vitamin A
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2006 (estimated)
- Study startAug 2006
- Study completionSep 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Eye ManifestationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Bialystok
- Sponsor type
- Other government
- Investigators
- Malgorzata Mrugacz, MD, PhD, Principal investigator, Department of Pediatric Ophthalmology Medical University of Bialystok, Poland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00345280
- Sponsor's protocol ID
- 8789
- Other IDs
- N40605131/1894
- Status last verified
- Jun 2008
- First submitted
- 27 Jun 2006
- Last updated
- 17 Jun 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chosen Parameters of the Immune Response in the Origin of Ocular Changes in Patients With Cystic Fibrosis
- ClinicalTrials.gov ID
- NCT00345280
- Acronym / sponsor ID
- 8789
- Conditions
- Eye Manifestations
- Keywords
- Cystic fibrosis, eye, inflammation, apoptosis, C11+
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- University of BialystokOther government
- Study start
- Aug 2006
- Study completion
- Sep 2008 (estimated)
- First posted
- 28 Jun 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The aim: To assess the role of chosen parameters of immunological response in the induction of ocular changes in cystic fibrosis patients, particularly chosen chemokine concentrations in the tear fluid and analysis of chosen apoptotic markers expression on conjunctival epithelial cells.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 3 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- 26 male and female patients aged 3-25 with clinically definite diagnosis of cystic fibrosis
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| impression cytology, obtain the tear fluidAlso: Becton DickinsonVitamin A | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Malgorzata Mrugacz, MD, PhD principal investigator
Department of Pediatric Ophthalmology Medical University of Bialystok, Poland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Eye Manifestations, run by University of Bialystok at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Jun 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Michal Sewerynski, Prof. (+48 22 6281944, minister@mnisw.gov.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2008.