Novel diagnostic approaches and markers for follow-up in systemic sclerosis

Novel diagnostic approaches and markers for follow-up in systemic sclerosis - Diagnosis and biomarkers in systemic sclerosis

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON45160

Enrollment

200

Registered

2013-11-11

Start date

2014-05-22

Completion date

Unknown

Last updated

2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

scleroderma systemic sclerosis

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 18-80 yrs diagnosis of scleroderma/systemic sclerosis according to the ECR criteria of 2013 Written informed consent

Exclusion criteria

Exclusion criteria: Under age of 18 or above 80 Incapacitated

Design outcomes

Primary

Measure	Time frame
Main study parameters include a) levels of: Connective tissue growth factor (CTGF) TGF-beta responsive gene signature N-terminal pro-peptide of type I (PINP) and type III (PIIINP) collagen C-terminal pro-peptide of type I collagen cross-linked carboxyterminal telopeptide of type I collagen C-terminal telopeptide of type I collagen soluble intercellular adhesion molecule-1 (sICAM-1) soluble vascular adhesion molecule 1 (sVCAM-1) E-selectin NT-proBNP Uric acid b) Presence (+ or -) of SSc specific autoantibody subtypes Scl-70, CENP A, CENP B, RP11, RP155, Fibrillarin, NOR90, Th/To, PM-Scl100, PM-Scl75, Ku, PDGFR, Ro-52 inflammatory parameters and interleukins c) EUSTAR SSc Activity Score The main endpoint is the correlation between the activity score (c) and presence and levels of markers as summarized under a and b.	—

Measure

Time frame

Main study parameters include a) levels of: Connective tissue growth factor (CTGF) TGF-beta responsive gene signature N-terminal pro-peptide of type I (PINP) and type III (PIIINP) collagen C-terminal pro-peptide of type I collagen cross-linked carboxyterminal telopeptide of type I collagen C-terminal telopeptide of type I collagen soluble intercellular adhesion molecule-1 (sICAM-1) soluble vascular adhesion molecule 1 (sVCAM-1) E-selectin NT-proBNP Uric acid b) Presence (+ or -) of SSc specific autoantibody subtypes Scl-70, CENP A, CENP B, RP11, RP155, Fibrillarin, NOR90, Th/To, PM-Scl100, PM-Scl75, Ku, PDGFR, Ro-52 inflammatory parameters and interleukins c) EUSTAR SSc Activity Score The main endpoint is the correlation between the activity score (c) and presence and levels of markers as summarized under a and b.

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Secondary

Measure	Time frame
Secondary endpoints relate to potential clinical significance of biomarkers in evaluating therapeutic efficacy. During follow-up and upon treatment levels and presence of markers will be evaluated and correlated with disease activity. In this way markers of treatment efficacy may be revealed.	—

Countries

Netherlands

Outcome results