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

• Sponsor: University Hospital, Tours (Other)
• Overall Status: Completed
• CT.gov ID: NCT04308616
• Collaborator: (none)
• Enrollment: 51
• Location: 1
• Actual Duration (Months): 21.2
• Patients Per Site Per Month: 2.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Psoriasis	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 Design

• Study Type: Observational
• Actual Enrollment: 51 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Utility of Squamous Cell Carcinoma Antigen (SCCA) in Psoriasis
• Actual Study Start Date: Jul 20, 2020
• Actual Primary Completion Date: Apr 27, 2022
• Actual Study Completion Date: Apr 27, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. SCCA blood concentration [Baseline, 3 months and 6 months]

   SCCA blood concentration will be measured at each visit

Secondary Outcome Measures

1. Assess correlations between SCCA blood concentration and proSPI severity score [Baseline, 3 months and 6 months]

   proSPI severity score (0-50) will be evaluated at each visit

2. Assess correlations between SCCA blood concentration and proSPI psychosocial score [Baseline, 3 months and 6 months]

   proSPI psychosocial score (0-10) will be evaluated at each visit

3. Assess correlations between SCCA blood concentration and proSPI treatment score [Baseline, 3 months and 6 months]

   proSPI treatment score (0-10) will be evaluated at each visit

4. Assess correlations between SCCA blood concentration and C reactive protein (CRP) [Baseline, 3 months and 6 months]

   CRP will be measured at each visit

5. Assess correlations between SCCA blood concentration and neutrophil/lymphocyte ratio [Baseline, 3 months and 6 months]

   neutrophil/lymphocyte ratio will be measured at each visit

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Dermatology Service, University Hospital, Tours	Tours		France	37044

Sponsors and Collaborators

• University Hospital, Tours

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University Hospital, Tours
• ClinicalTrials.gov Identifier: NCT04308616
• Other Study ID Numbers: RIPH3-RNI19/SCCAPSO; 2020-A00105-34
• First Posted: Mar 16, 2020
• Last Update Posted: Jun 1, 2022
• Last Verified: May 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by University Hospital, Tours: Psoriasis; Squamous Cell Carcinoma Antigen; SCCA; Biomarker
• Additional relevant MeSH terms: Carcinoma; Carcinoma, Squamous Cell; Psoriasis

Study Results

No Results Posted as of Jun 1, 2022