WartsNCT05781841
Gene Expression Of Suppressor Of Cytokines in In Cutaneous Warts
An observational study of Warts, run by Sohag University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Warts
- What is being tested?
- Detection of expression of SOCS3 gene, Detection of expression of IFN-α gene and Detection of expression of IFN-β gene
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Apr 2023to 30 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Adult
Study population: A-patients: - The study will include 35 patients with cutaneous warts aged18-50 years old and 15 age matched controls (blood donors).
Who may be able to join
- The study will include patients with cutaneous warts of various types aged 18-50 years old.
Who cannot join
- 1. 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment Of Gene Expression Of Suppressor Of Cytokine 3, Interferons Alpha And Beta In Cutaneous Warts
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.
Read the detailed description
Cutaneous warts are benign lesions caused by low risk-HPV. Of which the most prevalent genotypes are HPV1/2/3/4/10/27/57, and from these genotypes 1, 2, 4, 27, 57 cause common warts. Palmoplantar warts can be caused by genotypes 1 and 2. Condyloma acuminata (anogenital warts) are common sexually transmitted infections caused primarily by HPV-6 and HPV-11 (in 90% of cases) and occasionally by HPV-16 and HPV-18.
About 90% of HPV infections are eliminated within two years due to an efficient immune response. In the form of correct activation of the elements of the innate immune response, such as macrophages, polymorphonuclear cells, natural killer (NK) cells, which release immunomodulatory molecules that help control the infection. In addition, HPV-infected keratinocytes may act as non-professional antigen-presenting cells to promote the clearance of infected cells through the secretion of antiviral and pro-inflammatory mediators.
Interferon (IFN) belongs to a family of inducible cytokines which promote an"antiviral state" in infected cells and neighboring cells through the activation of interferon-stimulated genes (ISG). Three IFN types have been identified (type I, II and III), of which I and III are involved in the innate immune response. Type I IFNs include IFN-α, IFN-β, IFN-ɛ, IFN-κ and IFN-ω.
Most type I IFNs are induced through the binding of viral products to pattern recognition receptors, leading to activation of interferon response factors to drive the synthesis of IFN molecules. After secretion, type I IFNs bind to its receptor, which induces the phosphorylation of signal transducer and activator of transcription 1 (STAT1) and STAT2, which then translocate to the nucleus to induce transcription of (ISGs).
The antiviral effects of IFN-I are mediated by inducing several (ISGs) which impair viral replication through inhibition of protein translation and degradation of viral RNA. ISGs also activate the survival of innate and adaptive immune cells including dendritic cells, macrophages, NK cells and T cells. So, IFN-I helps to control the infections.
During the viral infection process, cytokines trigger and deal with inflammation. However, excessive production of cytokines can cause a cytokine storm, and excessive host innate immune response can also damage the body. Therefore, the suppressor of cytokine signaling proteins with negative feedback regulation ability, prevents the excessive secretion of cytokines from harming the host cell. These intracellular protein family is constituted by suppressor of cytokine signaling proteins 1-7, Which are potent endogenous inhibitors of Janus kinase (JAK/ STAT) signal.
The SOCS 3 is mainly involved in the negative feedback regulation of the tyrosine-protein kinase/ STAT signaling. The critical role of SOCS3 is manifested by its binding to both the JAK and the tyrosine kinase receptor, which further inhibits STAT3 phosphorylation. The JAK/STAT pathway transduces extracellular signals to the nucleus. Its activation stimulates cell proliferation, differentiation, migration, and immune challenge. The JAK/STAT signaling pathway plays an important role in viral infection.
The SOCS family are induced by various viral infections, including human immunodeficiency virus-1, hepatitis B and C viruses, herpes simplex virus type 1, respiratory syncytial virus, Ebola virus, influenza A, and coxsackie virus. Influenza A virus inhibits type I IFN signaling through the induction of SOCS3 expression. Newcastle disease virus (NDV) infection activates the expression of SOCS3 at the mRNA and protein level, which is conducive to the virus replication.
- Conditions
- Warts
- Being tested
- Detection of expression of SOCS3 gene, Detection of expression of IFN-α gene, Detection of expression of IFN-β gene
- Keywords
- HPV, Warts, STAT1, SOCS 3
- Medical subject headings
- Warts
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Detection of expression of SOCS3 geneDiagnostic test
Detection of expression of SOCS3, in each samples using Real-Time PCR
Detection of expression of IFN-α geneDiagnostic test
Detection of expression of IFN-α gene in each samples using Real-Time PCR
Detection of expression of IFN-β geneDiagnostic test
Detection of expression of IFN-β gene in each samples using Real-Time PCR
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Diagnostic Test: Detection of expression of SOCS3 gene; Diagnostic Test: Detection of expression of IFN-α gene; Diagnostic 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 Receives: Diagnostic Test: Detection of expression of SOCS3 gene; Diagnostic Test: Detection of expression of IFN-α gene; Diagnostic Test: Detection of expression of IFN-β gene |
What is being measured
The primary outcome is the main question the study is designed to answer.
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:
- Tissue grinding into smaller pieces then will be subjected for RNA extraction by automated kits according to its manufacture instruction.
- Conversion of RNA to double stranded DNA using RT( reverse transcriptase conversion Kits ) according to its manufacture instruction using conventional PCR.
- Detection of expression of SOCS3 gene in each samples using Real-Time PCR
Measured: 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:
- Tissue grinding into smaller pieces then will be subjected for RNA extraction by automated kits according to its manufacture instruction.
- Conversion of RNA to double stranded DNA using RT( reverse transcriptase conversion Kits ) according to its manufacture instruction using conventional PCR.
- Detection of expression of IFN-α gene in each samples using Real-Time PCR
Measured: 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:
- Tissue grinding into smaller pieces then will be subjected for RNA extraction by automated kits according to its manufacture instruction.
- Conversion of RNA to double stranded DNA using RT( reverse transcriptase conversion Kits ) according to its manufacture instruction using conventional PCR.
- Detection of expression of IFN-β gene in each samples using Real-Time PCR
Measured: from April 2023 to December 2023
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2023
- Study start15 Apr 2023
- Primary completion30 Sep 2023
- Study completion30 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for WartsStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Reham Helal Aboelhamd, Sohag University
- Investigators
- Hanan A Assaf, professor, Study chair, Sohag UniversityZeinab A Goda, lecturer, Study chair, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05781841
- Sponsor's protocol ID
- Soh-Med-23-03-7MS
- Status last verified
- Jul 2024
- First submitted
- 12 Mar 2023
- Last updated
- 23 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 30841905
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment Of Gene Expression Of Suppressor Of Cytokine 3, Interferons Alpha And Beta In Cutaneous Warts
- ClinicalTrials.gov ID
- NCT05781841
- Acronym / sponsor ID
- Soh-Med-23-03-7MS
- Conditions
- Warts
- Keywords
- HPV, Warts, STAT1, SOCS 3
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 15 Apr 2023 (actual)
- Primary completion
- 30 Sep 2023 (actual)
- Study completion
- 30 Dec 2023 (actual)
- First posted
- 23 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Cutaneous warts are benign lesions caused by low risk-HPV. Of which the most prevalent genotypes are HPV1/2/3/4/10/27/57, and from these genotypes 1, 2, 4, 27, 57 cause common warts. Palmoplantar warts can be caused by genotypes 1 and 2. Condyloma acuminata (anogenital warts) are common sexually transmitted infections caused primarily by HPV-6 and HPV-11 (in 90% of cases) and occasionally by HPV-16 and HPV-18.
About 90% of HPV infections are eliminated within two years due to an efficient immune response. In the form of correct activation of the elements of the innate immune response, such as macrophages, polymorphonuclear cells, natural killer (NK) cells, which release immunomodulatory molecules that help control the infection. In addition, HPV-infected keratinocytes may act as non-professional antigen-presenting cells to promote the clearance of infected cells through the secretion of antiviral and pro-inflammatory mediators.
Interferon (IFN) belongs to a family of inducible cytokines which promote an"antiviral state" in infected cells and neighboring cells through the activation of interferon-stimulated genes (ISG). Three IFN types have been identified (type I, II and III), of which I and III are involved in the innate immune response. Type I IFNs include IFN-α, IFN-β, IFN-ɛ, IFN-κ and IFN-ω.
Most type I IFNs are induced through the binding of viral products to pattern recognition receptors, leading to activation of interferon response factors to drive the synthesis of IFN molecules. After secretion, type I IFNs bind to its receptor, which induces the phosphorylation of signal transducer and activator of transcription 1 (STAT1) and STAT2, which then translocate to the nucleus to induce transcription of (ISGs).
The antiviral effects of IFN-I are mediated by inducing several (ISGs) which impair viral replication through inhibition of protein translation and degradation of viral RNA. ISGs also activate the survival of innate and adaptive immune cells including dendritic cells, macrophages, NK cells and T cells. So, IFN-I helps to control the infections.
During the viral infection process, cytokines trigger and deal with inflammation. However, excessive production of cytokines can cause a cytokine storm, and excessive host innate immune response can also damage the body. Therefore, the suppressor of cytokine signaling proteins with negative feedback regulation ability, prevents the excessive secretion of cytokines from harming the host cell. These intracellular protein family is constituted by suppressor of cytokine signaling proteins 1-7, Which are potent endogenous inhibitors of Janus kinase (JAK/ STAT) signal.
The SOCS 3 is mainly involved in the negative feedback regulation of the tyrosine-protein kinase/ STAT signaling. The critical role of SOCS3 is manifested by its binding to both the JAK and the tyrosine kinase receptor, which further inhibits STAT3 phosphorylation. The JAK/STAT pathway transduces extracellular signals to the nucleus. Its activation stimulates cell proliferation, differentiation, migration, and immune challenge. The JAK/STAT signaling pathway plays an important role in viral infection.
The SOCS family are induced by various viral infections, including human immunodeficiency virus-1, hepatitis B and C viruses, herpes simplex virus type 1, respiratory syncytial virus, Ebola virus, influenza A, and coxsackie virus. Influenza A virus inhibits type I IFN signaling through the induction of SOCS3 expression. Newcastle disease virus (NDV) infection activates the expression of SOCS3 at the mRNA and protein level, which is conducive to the virus replication.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients with cutaneous warts | – | Diagnostic Test: Detection of expression of SOCS3 gene, Diagnostic Test: Detection of expression of IFN-α gene, Diagnostic Test: Detection of expression of IFN-β geneUnder 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 |
| healthy volunteers | – | Diagnostic Test: Detection of expression of SOCS3 gene, Diagnostic Test: Detection of expression of IFN-α gene, Diagnostic Test: Detection of expression of IFN-β geneUnder 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 |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Age groups
- Adult
- Study population
- A-patients: - The study will include 35 patients with cutaneous warts aged18-50 years old and 15 age matched controls (blood donors).
Key inclusion criteria (1 listed)
- The study will include patients with cutaneous warts of various types aged 18-50 years old.
Key exclusion criteria (1 listed)
- 1. 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Detection of expression of SOCS3 geneDetection of expression of SOCS3, in each samples using Real-Time PCR | Diagnostic test | healthy volunteers, patients with cutaneous warts |
| Detection of expression of IFN-α geneDetection of expression of IFN-α gene in each samples using Real-Time PCR | Diagnostic test | healthy volunteers, patients with cutaneous warts |
| Detection of expression of IFN-β geneDetection of expression of IFN-β gene in each samples using Real-Time PCR | Diagnostic test | healthy volunteers, patients with cutaneous warts |
Primary outcome
This study aims to assess the expression of genes of SOCS3 in cutaneous warts.
Time frame: from april 2023 to December 2023
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
This study aims to assess the expression of genes of IFN-α in cutaneous warts.
Time frame: from April 2023 to December 2023
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
This study aims to assess the expression of genes of IFN-β in cutaneous warts.
Time frame: from April 2023 to December 2023
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2024.
- Background: PubMed 30841905Feng 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.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hanan A Assaf, professor study chair
Sohag University
Zeinab A Goda, lecturer study chair
Sohag University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Warts, run by Sohag University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
This study aims to assess the expression of genes of SOCS3 in cutaneous warts. (time frame: from april 2023 to December 2023). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05781841, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2024.