Ignite Creation Date:
2024-05-06 @ 4:27 PM
Last Modification Date:
2024-10-26 @ 2:10 PM
Study NCT ID:
NCT04996082
Status:
NOT_YET_RECRUITING
Last Update Posted:
2021-08-09
First Post:
2021-08-03
Brief Title:
Skin Fibrosis Analysis by Raman Spectroscopy in Systemic Sclerosis
Sponsor:
CHU de Reims
Organization:
CHU de Reims
Study Overview
Official Title:
Skin Fibrosis Analysis by Raman Spectroscopy in Systemic Sclerosis
Status:
NOT_YET_RECRUITING
Status Verified Date:
2021-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RAMSES
Brief Summary:
Systemic sclerosis SSc is a rare connective tissue disease characterized by a high clinical heterogeneity with unpredictable evolution that could engage functional and life-threatening prognosis Most of patients develop skin fibrosis gradually spreading Two clinical distinct forms are described according to the extension of skin fibrosis limited lSSc and diffuse dSSc SSc It is now admitted that a spreading of skin fibrosis is associated with poor prognosis This disease can be complicated by pulmonary arterial hypertension PAH interstitial lung disease ILD and scleroderma renal crisis SRC representing the main causes of death in SSc Usually PAH is associated with lSSc and ILD and SRC are associated with dSSc Prognosis is also different regarding skin phenotype with a higher mortality rate in dSSc
An easy score called modified Rodnan skin score is commonly used in clinical practice to evaluate the spreading and severity of skin fibrosis but this score is hardly reproducible Ultrasound can be used to measure skin thickness and is more reproducible than the Rodnan skin score Nevertheless non-invasive analysis of fibrosis composition in different areas is not possible with these two technics
Thus in this study we will investigate Raman spectroscopy a non-invasive technic based on the interaction of a low-intensity laser with matter
An easy score called modified Rodnan skin score is commonly used in clinical practice to evaluate the spreading and severity of skin fibrosis but this score is hardly reproducible Ultrasound can be used to measure skin thickness and is more reproducible than the Rodnan skin score Nevertheless non-invasive analysis of fibrosis composition in different areas is not possible with these two technics
Thus in this study we will investigate Raman spectroscopy a non-invasive technic based on the interaction of a low-intensity laser with matter
Detailed Description:
Raman spectroscopy will be performed on patients with SSc according to the ACR criteria and control patients without SSc on 3 different areas of the skin Patients with SSc and controls will be matched by gender and age These measures will be performed at 6 months 12 months 24 months and 36 months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None