Second Follow-up Study of COPD Patients and Healthy Controls for Evaluation of Predictive Non-coding RNA Biomarkers
NCT ID: NCT04895124
Last Updated: 2024-10-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
63 participants
OBSERVATIONAL
2021-05-25
2023-03-30
Brief Summary
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Of this cohort, 116 subjects were re-invited for the first follow-up study Ribolution II (NTC02522026) after 3 years (+/- 6 months) and data on the clinical course and treatment changes was obtained.
This second follow-up study will re-examine all available subjects regarding disease course and treatment changes after 3 years (+/-6 months) for the investigation of ncRNA/ transcriptome biomarkers for their potential to indicate disease progression. In addition, biobanking of respective biosamples for potential future COPD biomarker research will be conducted.
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Detailed Description
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Conditions
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Study Design
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COHORT
CROSS_SECTIONAL
Study Groups
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Healthy volunteers
No interventions assigned to this group
Healthy smokers
No interventions assigned to this group
COPD GOLD I
No interventions assigned to this group
COPD GOLD II
No interventions assigned to this group
COPD GOLD III/IV
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
2. Able and willing to give written informed consent.
3. Females will be considered for inclusion if they are: not pregnant, as confirmed by pregnancy test (see flow chart), and not nursing.
Exclusion Criteria
2. Past or present disease developed after the participation in "11-03 Ribolution" or "15-01 Ribolution II", which might interfere with study procedures.
3. Participation in another clinical trial 30 days prior to enrollment.
4. Current drug or alcohol abuse.
5. Risk of non-compliance with study procedures.
6. Suspected inability to understand the protocol requirements, instructions and study-related restrictions, the nature, scope, and possible consequences of the study.
7. History of an acute infection four weeks prior to the study procedures, including - but not limited to - moderate or severe exacerbation (requiring oral corticosteroid, antibiotics or hospitalization). All courses of oral corticosteroids and antibiotics must be completed at least four weeks prior to all study procedures (with the exception of the informed consent). In case of significant acute infections or moderate or severe exacerbation, the study participation can be split in two separate visits (1. Informed consent visit, 2. Study procedures visit, when subject is fully resolved, at least four weeks after the end of infection/ exacerbation).
8. If performed according to SOP FHI-1-18, positive SARS-CoV-2 rapid antigen test on Day 1. Subjects may be re-screened when confirmatory nucleic acid amplification test was negative or when officially ordered quarantine has ended.
9. Being a vulnerable subject (dependent, in detention or without mental capacity).
40 Years
75 Years
ALL
Yes
Sponsors
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Fraunhofer-Institute of Toxicology and Experimental Medicine
OTHER
Responsible Party
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Locations
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Fraunhofer Institute for Toxicology and Experimental Medicine
Hanover, Lower Saxony, Germany
Countries
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Other Identifiers
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19-12 Ribolution III
Identifier Type: -
Identifier Source: org_study_id
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