Utility of Squamous Cell Carcinoma Antigen (SCCA) in Psoriasis

Psoriasis Clinical Trial

— SCCAPSO  

Official title:

Utility of Squamous Cell Carcinoma Antigen (SCCA) in Psoriasis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04308616
• Other study ID #: RIPH3-RNI19/SCCAPSO
• Secondary ID: 2020-A00105-34
• Status: Completed
• Start date: July 20, 2020
• Est. completion date: April 27, 2022

Study information

• Verified date: May 2022
• Source: University Hospital, Tours
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Squamous Cell Carcinoma Antigen (SCCA) contributes to the pathogenesis of psoriasis by inhibiting cell apoptosis, exacerbating epidermal hyperplasia and skin inflammation. Three studies have shown a correlation between blood levels of SCCA and the severity of psoriasis.

Clinical scores of psoriasis severity are used in consultation to guide treatment of the disease (initiation of systemic therapy, dose escalation) but they suffer from several pitfalls: lack of inter- and intra-observer reproducibility, consumption of medical time.

A readily available, inexpensive (24 euros) blood marker could be an interesting alternative to these clinical scores.

Description:

Squamous Cell Carcinoma Antigen (SCCA) contributes to the pathogenesis of psoriasis by inhibiting cell apoptosis, exacerbating epidermal hyperplasia and skin inflammation. Three studies have shown a correlation between blood levels of SCCA and the severity of psoriasis.

Clinical scores of psoriasis severity are used in consultation to guide treatment of the disease (initiation of systemic therapy, dose escalation). The PASI (Psoriasis Assessment Severity Index, minimum score 0, maximum 72) is the most widely used. It suffers from several pitfalls: lack of inter- and intra-observer reproducibility, consumption of medical time. This PASI score was "unavoidable" in the international clinical studies used to obtain marketing authorisation for medicines. The PGA (Physician global assessment) is simpler and less time-consuming, ranging from 0 to 4, but is not very discriminating. More recently, a "Simplified Psoriasis Index" (proSPI) health professional score has been developed, which correlates well with PASI for the severity component of psoriasis and with quality of life for the psychological component of the disease. It is less time-consuming to establish than PASI, but suffers like all clinical scores from a problem of inter- and intra-observer reproducibility.

A readily available, inexpensive (24 euros) blood marker could be an interesting alternative to these clinical scores.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: April 27, 2022
• Est. primary completion date: April 27, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age = 18 years old

• Patient with skin psoriasis (new and untreated or being treated, flare-up or stable, possibly bleached)

• Requiring a blood sample for disease or treatment monitoring

Exclusion Criteria:

• History of invasive mucosal squamous cell carcinoma, or squamous cell carcinoma of the skin with lymph node or visceral recurrence.

• Patient under guardianship or curatorship

• Opposition to participation in the study

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Squamous Cell
• Psoriasis

Intervention

Other:
• Blood samples
Blood samples

Locations

Country	Name	City	State
France	Dermatology Service, University Hospital, Tours	Tours

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Tours

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	SCCA blood concentration	SCCA blood concentration will be measured at each visit	Baseline, 3 months and 6 months
Secondary	Assess correlations between SCCA blood concentration and proSPI severity score	proSPI severity score (0-50) will be evaluated at each visit	Baseline, 3 months and 6 months
Secondary	Assess correlations between SCCA blood concentration and proSPI psychosocial score	proSPI psychosocial score (0-10) will be evaluated at each visit	Baseline, 3 months and 6 months
Secondary	Assess correlations between SCCA blood concentration and proSPI treatment score	proSPI treatment score (0-10) will be evaluated at each visit	Baseline, 3 months and 6 months
Secondary	Assess correlations between SCCA blood concentration and C reactive protein (CRP)	CRP will be measured at each visit	Baseline, 3 months and 6 months
Secondary	Assess correlations between SCCA blood concentration and neutrophil/lymphocyte ratio	neutrophil/lymphocyte ratio will be measured at each visit	Baseline, 3 months and 6 months