Assessment of Squamous Cell Carcinoma antigen2 in Verruca Vulgaris

Sponsor
Sohag University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05409365
Collaborator
(none)
50
1
8
6.2

Study Details

Study Description

Brief Summary

This study aims to assess the expression of SCCA2 in the skin of patients with warts and to detect its correlation with characteristics of warts.

Condition or Disease Intervention/Treatment Phase
  • Other: Immunohistochemical staining monoclonal antibodies to SCCA2 (SERPINB4/ SCCA2 antibody)

Detailed Description

Type of the study: Cross sectional study. Patients: This study will include 25 patients with verruca vulgaris and 25 healthy volunteers.

Inclusion criteria:

Patients present with warts (verruca vulgaris type).

Exclusion criteria:

Subjects who presenting with allergic diseases or other dermatological diseases or had a history of squamous cell carcinoma will be excluded from this study One skin biopsy will be taken from each healthy volunteers of the control group via 2-mm disposable punches under complete sterile precautions. Two biopsies will be taken from patients with wart lesion one from verruca vulgaris via 5-mm disposable punches and another from non-affected skin via 2-mm disposable punches under complete sterile precautions.

Biopsy handling: Each specimen in both groups will be fixed in formalin and embedded in paraffin to form paraffin blocks. Serial sections will be obtained from each block and stained with hematoxylin and eosin (H&E) for histological diagnosis.

Stained sections will be examined under a light microscope. To confirm the diagnosis of wart, the grade of inflammation and the density of dermal inflammatory infiltrate will be classified as follows Grade 0, no infiltrate; Grade 1, mild; Grade 2, moderate; or Grade 3, marked infiltrate.

Immunohistochemical staining: investigators will use monoclonal antibodies to SCCA2 (SERPINB4/ SCCA2 antibody). Immunohistochemical staining will be performed the pattern of immunostaining for SCCA2 will be evaluated in both the epidermis and dermis of wart lesions. The immunohistochemical score (IHC) range will be as follows: 0: negative expression of SCCA2; 1+: weak expression of SCCA2; 2+: moderate expression of SCCA2; and 3+: strong expression of SCCA2.

Study Design

Study Type:
Observational
Anticipated Enrollment :
50 participants
Observational Model:
Case-Control
Time Perspective:
Cross-Sectional
Official Title:
Assessment of Squamous Cell Carcinoma antigen2 in Verruca Vulgaris
Actual Study Start Date :
May 1, 2022
Anticipated Primary Completion Date :
Nov 1, 2022
Anticipated Study Completion Date :
Jan 1, 2023

Outcome Measures

Primary Outcome Measures

  1. Assessment of Squamous Cell Carcinoma Antigen2 in Verruca Vulgaris [through study completion, an average of 1 year]

    Immunohistochemical staining: investigators will use monoclonal antibodies to SCCA2 (SERPINB4/ SCCA2 antibody). Immunohistochemical staining will be performed the pattern of immunostaining for SCCA2 will be evaluated in both the epidermis and dermis of wart lesions. The immunohistochemical score (IHC) range will be as follows: 0: negative expression of SCCA2; 1+: weak expression of SCCA2; 2+: moderate expression of SCCA2; and 3+: strong expression of SCCA2.

Eligibility Criteria

Criteria

Ages Eligible for Study:
1 Year and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Patients present with warts (verruca vulgaris type).
Exclusion Criteria:
  • Subjects who presenting with allergic diseases or other dermatological diseases or had a history of squamous cell carcinoma will be excluded from this study.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Sohag University Sohag Egypt

Sponsors and Collaborators

  • Sohag University

Investigators

  • Study Director: Ashraf Ahmed Abd El-Latif Abd El-Latif, Lecturer, Director

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Fatma Aboelmaged Abdelgaber, Resident of Dermatology and Venereology, Sohag University
ClinicalTrials.gov Identifier:
NCT05409365
Other Study ID Numbers:
  • Soh-Med-22-04-07
First Posted:
Jun 8, 2022
Last Update Posted:
Jun 10, 2022
Last Verified:
Jun 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 10, 2022