Identification of New Biomarkers to Promote Personalized Treatment of Patients With Inflammatory Rheumatic Diseases
NCT ID: NCT03214263
Last Updated: 2024-01-09
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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RECRUITING
20000 participants
OBSERVATIONAL
2015-05-31
2024-12-31
Brief Summary
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Methods and analysis: Observational and translational open cohort study with prospective collection of clinical data and biological materials in patients with inflammatory rheumatic diseases treated in routine care. Patients contribute one cross-sectional blood sample (i.e. whole blood, serum, EDTA-plasma and -buffy coat, and blood in PAXgene RNA tubes) and/or are enrolled for longitudinal follow-up upon start of new DMARD (blood sampling after 0/3/6/12/24/36/48/60 months' treatment). Demographics, disease characteristics, comorbidities and lifestyle factors are registered at inclusion; DMARD treatment and outcomes are collected repeatedly during follow-up. Currently (June 2017) \>5,000 samples from ≈3,000 patients have been collected. Data will be analysed using appropriate statistical analyses.
Ethics and dissemination: The protocol is approved by the Danish Ethics Committee and The Danish Data Protection Agency. All participants give written informed consent. Biomarkers will be evaluated and published according to REMARK, STROBE and STARD guidelines. Results will be published in peer-reviewed medical journals and presented at international conferences.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Cross-sectional samples:
Any patient followed in the DANBIO registry may be invited to participate when they meet for a scheduled routine clinical visit. These patients provide one cross-sectional blood sample.
No interventions assigned to this group
Longitudinal samples:
Any patient followed in the DANBIO registry will be invited to participate when they start treatment with a new DMARD. Switching from csDMARD to bDMARD, or from one bDMARD to another bDMARD indicates a new baseline.
No interventions assigned to this group
Samples of other biological material:
Patients followed in the DANBIO registry may be invited to participate if scheduled for one of the following procedures: joint puncture with extraction of synovial fluid, surgery or tissue sampling involving synovia, cartilage, bone, bone-marrow or other tissues. Representative samples from the synovial fluid or relevant tissue are collected after routine diagnostic or therapeutic analyses have been done
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Aged 18 year or older
* Able to give informed consent
Exclusion Criteria
18 Years
ALL
No
Sponsors
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University Hospital, Gentofte, Copenhagen
OTHER
Copenhagen University Hospital at Herlev
OTHER
King Christian X´Hospital for Rheumatic Diseases
OTHER
Svendborg Hospital
OTHER
Zealand University Hospital
OTHER
Aalborg University Hospital
OTHER
Aarhus University Hospital
OTHER
Sygehus Lillebaelt
OTHER
Odense University Hospital
OTHER
Hillerod Hospital, Denmark
OTHER
Randers Regional Hospital
OTHER
University Hospital Bispebjerg and Frederiksberg
OTHER
Rigshospitalet, Denmark
OTHER
Responsible Party
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Merete L Hetland
Professor
Principal Investigators
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Merete L Hetland, Professor
Role: PRINCIPAL_INVESTIGATOR
Rigshospitalet, Glostrup, Denmark
Locations
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Department of Rheumatology, Aalborg University Hospital
Aalborg, , Denmark
Department of Rheumatology, Aarhus University Hospital
Aarhus, , Denmark
Department of Rheumatology, Rigshospitalet
Copenhagen, , Denmark
Dept. of Rheumaology, University Hospital Bispebjerg and Frederiksberg
Copenhagen, , Denmark
Dept. of Rheumaology, North Denmark Regional Hospital
Hjørring, , Denmark
Department of Rheumatology, Zealand University Hospital Køge
Køge, , Denmark
Department of Rheumatology, Odense University Hospital
Odense, , Denmark
Dept. of Rheumaology, Randers Regional Hospital
Randers, , Denmark
Department of Rheumatology, Svendborg Hospital
Svendborg, , Denmark
Danish Arthritis Hospital
Sønderborg, , Denmark
Department of Rheumatology, Hospital Lillebaelt
Vejle, , Denmark
Countries
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Central Contacts
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References
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Kringelbach TM, Glintborg B, Hogdall EV, Johansen JS, Hetland ML; Biomarker Protocol Study Group. Identification of new biomarkers to promote personalised treatment of patients with inflammatory rheumatic disease: protocol for an open cohort study. BMJ Open. 2018 Feb 1;8(2):e019325. doi: 10.1136/bmjopen-2017-019325.
Related Links
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Bio- and GenomeBank Denmark and Danish Rheumatologic Biobank
DANBIO
Other Identifiers
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REUM BIOMARKØRER 2014-10-30
Identifier Type: -
Identifier Source: org_study_id
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