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临床试验/NCT04308616
NCT04308616已完成不适用

Utility of Squamous Cell Carcinoma Antigen (SCCA) in Psoriasis

University Hospital, Tours1 个研究点 分布在 1 个国家目标入组 51 人开始时间: 2020年7月20日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
51
试验地点
1
主要终点
SCCA blood concentration

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

SCCA blood concentration

时间窗: Baseline, 3 months and 6 months

SCCA blood concentration will be measured at each visit

次要结局

  • Assess correlations between SCCA blood concentration and proSPI severity score(Baseline, 3 months and 6 months)
  • Assess correlations between SCCA blood concentration and neutrophil/lymphocyte ratio(Baseline, 3 months and 6 months)
  • Assess correlations between SCCA blood concentration and proSPI psychosocial score(Baseline, 3 months and 6 months)
  • Assess correlations between SCCA blood concentration and proSPI treatment score(Baseline, 3 months and 6 months)
  • Assess correlations between SCCA blood concentration and C reactive protein (CRP)(Baseline, 3 months and 6 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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