Evaluation of Oral EGCG Treatment for L-SIL Associated With HPV Infection

NCT06314113 | Recruiting DMC

• 1 other identifier: EGCG-HPV
• Study Type: observational
• Estimated enrollment: 50
• Locations: 1 country
• Sites: 1
• Actual (reported): Study Start
• Estimated — date passed: Primary Completion
• Estimated — date passed: Study Completion

Brief Summary

The study aims to evaluate the effectiveness of the synergy of oral Epigallocatechin Gallate as a treatment for Low-grade Cervical Lesions (L-SIL) associated with Human Papilloma Virus (HPV) infection.

Conditions

Low-Grade Intraepithelial Neoplasia of Cervix

Keywords

Human Papilloma Virus (HPV); Low-Grade Intraepithelial Neoplasia of Cervix; Epigallocatechin Gallate

Outcome Measures

Primary Outcomes (1)

• Persistence

  Persistence of Low-grade Cervical Lesions (L-SIL), evaluated by pap smear

  After 6, 12, 18, and 24 months from the recruitment

Study Arms (1)

Low-grade Cervical Lesions (L-SIL)

Women affected by Low-grade Cervical Lesions (L-SIL) associated with Human Papilloma Virus (HPV) Infection

Dietary Supplement: Epigallocatechin Gallate

Interventions

Epigallocatechin Gallate DIETARY_SUPPLEMENT

Oral treatment with Epigallocatechin Gallate 200 mg per day

Low-grade Cervical Lesions (L-SIL)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Women affected by Low-grade Cervical Lesions (L-SIL) associated with Human Papilloma Virus (HPV) Infection

You may qualify if:

• Women affected by Low-grade Cervical Lesions (L-SIL) associated with Human Papilloma Virus (HPV) Infection

You may not qualify if:

• Pregnancy
• Concomitant pathologies causing immunosuppression
• Concurrent Immunomodulatory therapies
• Hormone replacement therapy
• High-grade Cervical Lesions (H-SIL) or in situ adenocarcinoma
• Previous history of L-SIL or higher grade lesions ≥ 24 months

Sponsors & Collaborators

• University of Palermo: lead

Study Sites (1)

"Paolo Giaccone" Hospital

Palermo, 90127, Italy

RECRUITING

MeSH Terms

Interventions

epigallocatechin gallate

Study Officials

• Antonio Simone Laganà, M.D., Ph.D.

  University of Palermo

  PRINCIPAL INVESTIGATOR

• Giuseppe Mascellino, M.D.

  University of Palermo

  STUDY CHAIR

• Pietro Serra, M.D.

  University of Palermo

  STUDY CHAIR

• Andrea Etrusco, M.D.

  University of Palermo

  STUDY CHAIR

Central Study Contacts

Antonio Simone Laganà, M.D., Ph.D.

CONTACT

+39 3296279579; antoniosimone.lagana@unipa.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 10, 2024
• First Posted: March 15, 2024
• Last Updated: March 15, 2024

Study Start

March 1, 2024

Actual (reported)

Primary Completion

March 1, 2025

Estimated — date passed

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Study Completion

September 1, 2025

Estimated — date passed

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)