Human Papillomavirus InfectionNCT06005389
Serum Galectin-3 as a Marker of Human Papillomavirus Infection
An observational study of Human Papillomavirus Infection, run by Assiut University at 1 site in Egypt.
Trial summary
This study aimed to assess the serum Galectin-3 levels in patients with warts both before and after cryotherapy and to investigate its potential contribution to the pathogenesis of human papillomavirus infection. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Human Papillomavirus Infection
- What is being tested?
- cryotherapy and serum Galectin-3 assay
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2021to 1 Feb 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: This case-control study was performed on 50 patients with any type of cutaneous warts except for genital warts and 50 apparently healthy age-and sex-matched control subjects without a history of warts attending the Outpatient Clinic of Dermatology, Venereology and Andrology Department of Assiut University Hospitals.
Who may be able to join
- Patients with non-genital warts.
- Age of patients: from 18 to 60 years.
Who cannot join
- Patients with genital and mucosal warts.
- Pregnancy and breastfeeding.
- Patients who received any wart treatment during the last month before enrollment in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Serum Galectin-3: A Potential Marker of Human Papillomavirus Infection Before and After Treatment of Cutaneous Warts
This study aimed to assess the serum Galectin-3 levels in patients with warts both before and after cryotherapy and to investigate its potential contribution to the pathogenesis of human papillomavirus infection.
Read the detailed description
Galectin-3 regulates many functions at the cellular level such as cell attachment, proliferation, and apoptosis. Numerous viral illnesses, including human papillomavirus infection, were reported to have elevated serum levels of Galectin-3. .
Methods: Fifty patients suffering from warts, and fifty healthy controls were included in this study. Enzyme-linked immunosorbent assay was used to measure serum levels of Galectin-3 both before and 2 weeks after the last cryotherapy session.
- Conditions
- Human Papillomavirus Infection
- Being tested
- cryotherapy, serum Galectin-3 assay
- Keywords
- Galectin-3, Human papillomavirus, Warts, Cryotherapy
- Medical subject headings
- Papillomavirus Infections, Warts
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cryotherapyProcedure or surgery
Every patient had a cryotherapy session every 2 weeks until complete clearance for a maximum of six sessions and follow-up was done at 3 months after treatment completion to detect any recurrence. Each wart was frozen using the spray technique by CRY-AC Liquid Nitrogen Dispenser Brymill, USA for 10 to 30 seconds until a 1- to 2-mm ice ball halo was formed surrounding the targeted area.
serum Galectin-3 assayDiagnostic test
From each patient and control, 3 ml venous blood was withdrawn under complete aseptic conditions before treatment and 2 weeks after the last treatment session by a disposable plastic syringe; the collected blood was placed on a plain tube without anticoagulant for 30 min at room temperature till coagulation occurs; after this, centrifugation of tubes was done for 20 min at 1000 rpm. The serum was separated into an aliquot and placed at -20 degrees Celsius for further analysis. Serum Gal-3 was measured using human Galectin-3 enzyme-linked immunosorbent assay (ELISA) kits supplied by ELK Biotechnology CO., LTD, Wuhan, China, catalog number (ELK2790) based on the Sandwich-ELISA technique as per the manufacturer's instructions.
| Study group | Role | What they receive |
|---|---|---|
| 50 patients with common or planter cutaneous warts | Every patient had a cryotherapy session every 2 weeks until complete clearance for a maximum of six sessions and follow-up was done at 3 months after treatment completion to detect any recurrence. The therapeutic efficacy was evaluated by a decrease in the size (measured by a ruler) and the number of warts with photographic documentation at (the baseline, each visit, 2 weeks after the final session, and the 3 months follow-up period). The response of the treated wart was considered: complete; if there was a disappearance of the wart and appearance of normal skin markings, partial; if the warts had regressed in size or decreased in number and no response; if no decrease in wart size or number.
From each patient 3 ml venous blood was withdrawn under complete aseptic conditions before treatment and 2 weeks after the last treatment session by a disposable plastic syringe. Serum Gal-3 was measured using human Galectin-3 enzyme-linked immunosorbent assay (ELISA) kits. Receives: Procedure: cryotherapy; Diagnostic Test: serum Galectin-3 assay | |
| 50 healthy age-and sex-matched control subjects. | From each control subject, 3 ml venous blood was withdrawn under complete aseptic conditions before treatment and 2 weeks after the last treatment session by a disposable plastic syringe. Serum Gal-3 was measured using human Galectin-3 enzyme-linked immunosorbent assay (ELISA) kits. Receives: Diagnostic Test: serum Galectin-3 assay |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum Galectin-3 levels assessment in patients with cutaneous warts.
3 ml of venous blood from each patient and control was drawn under strict aseptic conditions employing a single-use plastic syringe. Once the blood had been collected, it was put in a simple tube without an anticoagulant and left there for 30 minutes at room temperature until coagulation had taken place. The tubes were then centrifuged at 1000 rpm for 20 minutes. For further examination, an aliquot of the serum was taken and stored at 20 degrees Celsius. Human Galectin-3 enzyme-linked immunosorbent assay (ELISA) kits with the catalogue number (ELK2790) from ELK Biotechnology CO., LTD, Wuhan, China, were used to quantify serum Gal-3 in accordance with the manufacturer's instructions.
Measured: 1 year
look at Galectin-3 serum level conceivable contribution to the aetiology of HPV infection, and determine how cryotherapy affected serum Galectin-3 levels.
All patients had a thorough medical history taken, which included information on their age, sex, occupation, the number of warts, their location, size, and past treatments, as well as any previous systemic or skin conditions or drug use. A thorough examination was performed on each patient to determine the location, kind, size, and number of warts as well as to rule out any systemic or other skin conditions.
Before and two weeks after the last cryotherapy treatment session, serum Galectin-3 was assessed. Every patient had a cryotherapy session every 2 weeks until complete clearance for a maximum of six sessions and follow-up was done at 3 months after treatment completion to detect any recurrence. Each wart was frozen using the spray technique by CRY-AC Liquid Nitrogen Dispenser Brymill, USA for 10 to 30 seconds until an ice ball halo of 1 to 2 mm diameter encircled the intended area.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2023
- Study start1 Dec 2021
- Primary completion1 Dec 2022
- Study completion1 Feb 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 Human Papillomavirus InfectionStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Heba Hasan Sayed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06005389
- Sponsor's protocol ID
- Galectin-3 and HPV infection
- Status last verified
- Aug 2023
- First submitted
- 4 Aug 2023
- Last updated
- 22 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Coppock JD, Mills AM, Stelow EB. Galectin-3 Expression in High-Risk HPV-Positive and Negative Head & Neck Squamous Cell Carcinomas and Regional Lymph Node Metastases. Head Neck Pathol. 2021 Mar;15(1):163-168. doi: 10.1007/s12105-020-01195-3. Epub 2020 Jun 20.
PubMed 32564273
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serum Galectin-3: A Potential Marker of Human Papillomavirus Infection Before and After Treatment of Cutaneous Warts
- ClinicalTrials.gov ID
- NCT06005389
- Acronym / sponsor ID
- Galectin-3 and HPV infection
- Conditions
- Human Papillomavirus Infection
- Keywords
- Galectin-3, Human papillomavirus, Warts, Cryotherapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 1 Dec 2022 (actual)
- Study completion
- 1 Feb 2023 (actual)
- First posted
- 22 Aug 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.
This study aimed to assess the serum Galectin-3 levels in patients with warts both before and after cryotherapy and to investigate its potential contribution to the pathogenesis of human papillomavirus infection.
Detailed description
Galectin-3 regulates many functions at the cellular level such as cell attachment, proliferation, and apoptosis. Numerous viral illnesses, including human papillomavirus infection, were reported to have elevated serum levels of Galectin-3. .
Methods: Fifty patients suffering from warts, and fifty healthy controls were included in this study. Enzyme-linked immunosorbent assay was used to measure serum levels of Galectin-3 both before and 2 weeks after the last cryotherapy session.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 50 patients with common or planter cutaneous warts | – | Procedure: cryotherapy, Diagnostic Test: serum Galectin-3 assayEvery patient had a cryotherapy session every 2 weeks until complete clearance for a maximum of six sessions and follow-up was done at 3 months after treatment completion to detect any recurrence. The therapeutic efficacy was evaluated by a decrease in the size (measured by a ruler) and the number of warts with photographic documentation at (the baseline, each visit, 2 weeks after the final session, and the 3 months follow-up period). The response of the treated wart was considered: complete; if there was a disappearance of the wart and appearance of normal skin markings, partial; if the warts had regressed in size or decreased in number and no response; if no decrease in wart size or number. From each patient 3 ml venous blood was withdrawn under complete aseptic conditions before treatment and 2 weeks after the last treatment session by a disposable plastic syringe. Serum Gal-3 was measured using human Galectin-3 enzyme-linked immunosorbent assay (ELISA) kits. |
| 50 healthy age-and sex-matched control subjects. | – | Diagnostic Test: serum Galectin-3 assayFrom each control subject, 3 ml venous blood was withdrawn under complete aseptic conditions before treatment and 2 weeks after the last treatment session by a disposable plastic syringe. Serum Gal-3 was measured using human Galectin-3 enzyme-linked immunosorbent assay (ELISA) kits. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- This case-control study was performed on 50 patients with any type of cutaneous warts except for genital warts and 50 apparently healthy age-and sex-matched control subjects without a history of warts attending the Outpatient Clinic of Dermatology, Venereology and Andrology Department of Assiut University Hospitals.
Key inclusion criteria (2 listed)
- Patients with non-genital warts.
- Age of patients: from 18 to 60 years.
Key exclusion criteria (3 listed)
- Patients with genital and mucosal warts.
- Pregnancy and breastfeeding.
- Patients who received any wart treatment during the last month before enrollment in the study.
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 |
|---|---|---|
| cryotherapyEvery patient had a cryotherapy session every 2 weeks until complete clearance for a maximum of six sessions and follow-up was done at 3 months after treatment completion to detect any recurrence. Each wart was frozen using the spray technique by CRY-AC Liquid Nitrogen Dispenser Brymill, USA for 10 to 30 seconds until a 1- to 2-mm ice ball halo was formed surrounding the targeted area. | Procedure or surgery | 50 patients with common or planter cutaneous warts |
| serum Galectin-3 assayFrom each patient and control, 3 ml venous blood was withdrawn under complete aseptic conditions before treatment and 2 weeks after the last treatment session by a disposable plastic syringe; the collected blood was placed on a plain tube without anticoagulant for 30 min at room temperature till coagulation occurs; after this, centrifugation of tubes was done for 20 min at 1000 rpm. The serum was separated into an aliquot and placed at -20 degrees Celsius for further analysis. Serum Gal-3 was measured using human Galectin-3 enzyme-linked immunosorbent assay (ELISA) kits supplied by ELK Biotechnology CO., LTD, Wuhan, China, catalog number (ELK2790) based on the Sandwich-ELISA technique as per the manufacturer's instructions. | Diagnostic test | 50 healthy age-and sex-matched control subjects., 50 patients with common or planter cutaneous warts |
Primary outcome
Serum Galectin-3 levels assessment in patients with cutaneous warts.
Time frame: 1 year
3 ml of venous blood from each patient and control was drawn under strict aseptic conditions employing a single-use plastic syringe. Once the blood had been collected, it was put in a simple tube without an anticoagulant and left there for 30 minutes at room temperature until coagulation had taken place. The tubes were then centrifuged at 1000 rpm for 20 minutes. For further examination, an aliquot of the serum was taken and stored at 20 degrees Celsius. Human Galectin-3 enzyme-linked immunosorbent assay (ELISA) kits with the catalogue number (ELK2790) from ELK Biotechnology CO., LTD, Wuhan, China, were used to quantify serum Gal-3 in accordance with the manufacturer's instructions.
look at Galectin-3 serum level conceivable contribution to the aetiology of HPV infection, and determine how cryotherapy affected serum Galectin-3 levels.
Time frame: 1 year
All patients had a thorough medical history taken, which included information on their age, sex, occupation, the number of warts, their location, size, and past treatments, as well as any previous systemic or skin conditions or drug use. A thorough examination was performed on each patient to determine the location, kind, size, and number of warts as well as to rule out any systemic or other skin conditions. Before and two weeks after the last cryotherapy treatment session, serum Galectin-3 was assessed. Every patient had a cryotherapy session every 2 weeks until complete clearance for a maximum of six sessions and follow-up was done at 3 months after treatment completion to detect any recurrence. Each wart was frozen using the spray technique by CRY-AC Liquid Nitrogen Dispenser Brymill, USA for 10 to 30 seconds until an ice ball halo of 1 to 2 mm diameter encircled the intended area.
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 22 Aug 2023.
- Background: PubMed 32564273Coppock JD, Mills AM, Stelow EB. Galectin-3 Expression in High-Risk HPV-Positive and Negative Head & Neck Squamous Cell Carcinomas and Regional Lymph Node Metastases. Head Neck Pathol. 2021 Mar;15(1):163-168. doi: 10.1007/s12105-020-01195-3. Epub 2020 Jun 20.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Human Papillomavirus Infection, run by Assiut 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 2 inclusion and 3 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 22 Aug 2023. 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?
Serum Galectin-3 levels assessment in patients with cutaneous warts. (time frame: 1 year). The study lists 2 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 NCT06005389, 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 22 Aug 2023.