Serum Galectin-3 as a Marker of Human Papillomavirus Infection

NCT ID: NCT06005389

Last Updated: 2023-08-22

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-12-01
• Study Completion Date: 2023-02-01

Brief 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.

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

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

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From each patient 3 ml venous blood was withdrawn under complete aseptic conditions before treatment and 2 weeks after the last treatment session by a disposable plastic syringe.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.

cryotherapy

Intervention Type: PROCEDURE

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 assay

Intervention Type: DIAGNOSTIC_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.

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.

serum Galectin-3 assay

Intervention Type: DIAGNOSTIC_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.

Interventions

cryotherapy

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.

Intervention Type: PROCEDURE

serum Galectin-3 assay

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.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

1. Patients with non-genital warts.

2. Age of patients: from 18 to 60 years.

Exclusion Criteria

1. Patients with genital and mucosal warts.

2. Pregnancy and breastfeeding.

3. Patients who received any wart treatment during the last month before enrollment in the study.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Heba Hasan Sayed

lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Assiut University

Asyut, , Egypt

Countries

Egypt

References

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.

Reference Type: BACKGROUND

PMID: 32564273 (View on PubMed)

Other Identifiers

Galectin-3 and HPV infection

Identifier Type: -

Identifier Source: org_study_id