Clinical trial NCT04308616: Utility of Squamous Cell Carcinoma Antigen (SCCA) in Psoriasis
Official title: Utility of Squamous Cell Carcinoma Antigen (SCCA) in Psoriasis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Psoriasis
Keywords: Psoriasis
Squamous Cell Carcinoma Antigen
SCCA
Biomarker
Lead sponsor: University Hospital, Tours
Sponsor class: OTHER
First posted: 2020-03-16
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with psoriasis

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: SCCA blood concentration
timeFrame: Baseline, 3 months and 6 months
Secondary outcomes:
measure: Assess correlations between SCCA blood concentration and proSPI severity score
timeFrame: Baseline, 3 months and 6 months
measure: Assess correlations between SCCA blood concentration and proSPI psychosocial score
timeFrame: Baseline, 3 months and 6 months
measure: Assess correlations between SCCA blood concentration and proSPI treatment score
timeFrame: Baseline, 3 months and 6 months
measure: Assess correlations between SCCA blood concentration and C reactive protein (CRP)
timeFrame: Baseline, 3 months and 6 months
measure: Assess correlations between SCCA blood concentration and neutrophil/lymphocyte ratio
timeFrame: Baseline, 3 months and 6 months
Other outcomes:
Locations:
city: Tours
country: France
facility: Dermatology Service, University Hospital, Tours
Study officials:
affiliation: University Hospital, Tours
name: Laurent MACHET, MD-PhD
role: PRINCIPAL_INVESTIGATOR
References: