Utility of Squamous Cell Carcinoma Antigen (SCCA) in Psoriasis

NCT04308616 | Completed

• 2 other identifiers: RIPH3-RNI19/SCCAPSO2020-A00105-34
• Study Type: observational
• Target: 51
• Locations: 1 country
• Sites: 1

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.

Conditions

Psoriasis

Keywords

Psoriasis; Squamous Cell Carcinoma Antigen; SCCA; Biomarker

Outcome Measures

Primary Outcomes (1)

• SCCA blood concentration

  SCCA blood concentration will be measured at each visit

  Baseline, 3 months and 6 months

Secondary Outcomes (5)

• Assess correlations between SCCA blood concentration and proSPI severity score

  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

• Assess correlations between SCCA blood concentration and neutrophil/lymphocyte ratio

  Baseline, 3 months and 6 months

Study Arms (1)

Psoriasis

Patients with psoriasis

Other: Blood samples

Interventions

Blood samples OTHER

Blood samples

Psoriasis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with psoriasis

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Tours: lead

Study Sites (1)

Dermatology Service, University Hospital, Tours

Tours, 37044, France

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples

MeSH Terms

Conditions

Psoriasis

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Laurent MACHET, MD-PhD

  University Hospital, Tours

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 5, 2020
• First Posted: March 16, 2020
• Study Start: July 20, 2020
• Primary Completion: April 27, 2022
• Study Completion: April 27, 2022
• Last Updated: June 1, 2022

Record last verified: 2022-05

Locations

FR (1)