NCT05781841

Brief Summary

Warts are common epidermal growths caused by various strains of human papilloma virus (HPV). Viral warts are common with a prevalence rate of 7-12%. Human papilloma virus is small non enveloped viruses that contain a double-stranded DNA genome. There are more than 200 HPV genotypes are reported, however, the high-risk types, including HPV genotype-16 (HPV16), 18, 31, and 45, are the causes of 80% of cervical cancers.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 12, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 23, 2023

Completed
23 days until next milestone

Study Start

First participant enrolled

April 15, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2023

Completed
Last Updated

July 23, 2024

Status Verified

July 1, 2024

Enrollment Period

6 months

First QC Date

March 12, 2023

Last Update Submit

July 19, 2024

Conditions

Warts

Keywords

HPVWartsSTAT1SOCS 3

Outcome Measures

Primary Outcomes (3)

  • This study aims to assess the expression of genes of SOCS3 in cutaneous warts.

    Under complete sterile precautions, Skin biopsy will be taken from healthy volunteers of the control group via 2 mm disposable punches and from patients with wart lesion. The specimen will be put in sterile plane tube containing saline and will be transferred immediately to the central research laboratory to be processed as follow: 1. Tissue grinding into smaller pieces then will be subjected for RNA extraction by automated kits according to its manufacture instruction. 2. Conversion of RNA to double stranded DNA using RT( reverse transcriptase conversion Kits ) according to its manufacture instruction using conventional PCR. 3. Detection of expression of SOCS3 gene in each samples using Real-Time PCR

    from april 2023 to December 2023

  • This study aims to assess the expression of genes of IFN-α in cutaneous warts.

    Under complete sterile precautions, Skin biopsy will be taken from healthy volunteers of the control group via 2 mm disposable punches and from patients with wart lesion. The specimen will be put in sterile plane tube containing saline and will be transferred immediately to the central research laboratory to be processed as follow: 1. Tissue grinding into smaller pieces then will be subjected for RNA extraction by automated kits according to its manufacture instruction. 2. Conversion of RNA to double stranded DNA using RT( reverse transcriptase conversion Kits ) according to its manufacture instruction using conventional PCR. 3. Detection of expression of IFN-α gene in each samples using Real-Time PCR

    from April 2023 to December 2023

  • This study aims to assess the expression of genes of IFN-β in cutaneous warts.

    Under complete sterile precautions, Skin biopsy will be taken from healthy volunteers of the control group via 2 mm disposable punches and from patients with wart lesion. The specimen will be put in sterile plane tube containing saline and will be transferred immediately to the central research laboratory to be processed as follow: 1. Tissue grinding into smaller pieces then will be subjected for RNA extraction by automated kits according to its manufacture instruction. 2. Conversion of RNA to double stranded DNA using RT( reverse transcriptase conversion Kits ) according to its manufacture instruction using conventional PCR. 3. Detection of expression of IFN-β gene in each samples using Real-Time PCR

    from April 2023 to December 2023

Study Arms (2)

patients with cutaneous warts

Under complete sterile precautions, Skin biopsy will be taken from patients with wart lesion. The specimen will be put in sterile plane tube containing saline and will be transferred immediately to the central research laboratory to be processed

Diagnostic Test: Detection of expression of SOCS3 geneDiagnostic Test: Detection of expression of IFN-α geneDiagnostic Test: Detection of expression of IFN-β gene

healthy volunteers

Under complete sterile precautions, Skin biopsy will be taken from healthy volunteers of the control group via 2 mm disposable punches . The specimen will be put in sterile plane tube containing saline and will be transferred immediately to the central research laboratory to be processed

Diagnostic Test: Detection of expression of SOCS3 geneDiagnostic Test: Detection of expression of IFN-α geneDiagnostic Test: Detection of expression of IFN-β gene

Interventions

Detection of expression of SOCS3 geneDIAGNOSTIC_TEST

Detection of expression of SOCS3, in each samples using Real-Time PCR

healthy volunteerspatients with cutaneous warts
Detection of expression of IFN-α geneDIAGNOSTIC_TEST

Detection of expression of IFN-α gene in each samples using Real-Time PCR

healthy volunteerspatients with cutaneous warts
Detection of expression of IFN-β geneDIAGNOSTIC_TEST

Detection of expression of IFN-β gene in each samples using Real-Time PCR

healthy volunteerspatients with cutaneous warts

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

A-patients: - The study will include 35 patients with cutaneous warts aged18-50 years old and 15 age matched controls (blood donors).

You may qualify if:

  • The study will include patients with cutaneous warts of various types aged 18-50 years old.

You may not qualify if:

  • \. Pregnancy 2. Lactation 3. Patient on anti-inflammatory and antioxidant drugs 4. Skin infections, other than warts 5. Skin diseases 6. Systemic infection. 7. Malignancies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sohag University Hospital

Sohag, 523456, Egypt

Location

Related Publications (1)

  • Feng M, Xie T, Li Y, Zhang N, Lu Q, Zhou Y, Shi M, Sun J, Zhang X. A balanced game: chicken macrophage response to ALV-J infection. Vet Res. 2019 Mar 6;50(1):20. doi: 10.1186/s13567-019-0638-y.

    PMID: 30841905BACKGROUND

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

Under complete sterile precautions, Skin biopsy will be taken from healthy volunteers of the control group via 2 mm disposable punches and from patients with wart lesion

MeSH Terms

Conditions

Warts

Condition Hierarchy (Ancestors)

Papillomavirus InfectionsDNA Virus InfectionsVirus DiseasesInfectionsSkin Diseases, ViralTumor Virus InfectionsSkin Diseases, InfectiousSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Hanan A Assaf, professor

    Sohag University

    STUDY CHAIR

  • Zeinab A Goda, lecturer

    Sohag University

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

March 12, 2023

First Posted

March 23, 2023

Study Start

April 15, 2023

Primary Completion

September 30, 2023

Study Completion

December 30, 2023

Last Updated

July 23, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)