Utility of Squamous Cell Carcinoma Antigen (SCCA) in Psoriasis (SCCAPSO)

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.

Study Overview

• Status: Completed
• Conditions: Psoriasis
• Intervention / Treatment: Other: Blood samples

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 51

Contacts and Locations

Study Locations

• France
  • Tours, France, 37044
    • Dermatology Service, University Hospital, Tours

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with psoriasis

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Psoriasis; Patients with psoriasis	Other: Blood samples; Blood samples

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
SCCA blood concentration	SCCA blood concentration will be measured at each visit	Baseline, 3 months and 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
Assess correlations between SCCA blood concentration and C reactive protein (CRP)	CRP will be measured at each visit	Baseline, 3 months and 6 months
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

Collaborators and Investigators

• Sponsor: University Hospital, Tours
• Investigators: Principal Investigator: Laurent MACHET, MD-PhD, University Hospital, Tours

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 20, 2020
• Primary Completion (ACTUAL): April 27, 2022
• Study Completion (ACTUAL): April 27, 2022

Study Registration Dates

• First Submitted: March 5, 2020
• First Submitted That Met QC Criteria: March 11, 2020
• First Posted (ACTUAL): March 16, 2020

Study Record Updates

• Last Update Posted (ACTUAL): June 1, 2022
• Last Update Submitted That Met QC Criteria: May 30, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: Biomarker; Psoriasis; SCCA; Squamous Cell Carcinoma Antigen
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Skin Diseases, Papulosquamous; Neoplasms, Squamous Cell; Carcinoma; Psoriasis; Carcinoma, Squamous Cell
• Other Study ID Numbers: RIPH3-RNI19/SCCAPSO; 2020-A00105-34 (OTHER: IdRCB)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No