Ignite Creation Date:
2024-05-06 @ 8:16 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06314113
Status:
RECRUITING
Last Update Posted:
2024-03-15
First Post:
2024-03-10
Brief Title:
Evaluation of Oral EGCG Treatment for L-SIL Associated With HPV Infection
Sponsor:
University of Palermo
Organization:
University of Palermo
Study Overview
Official Title:
Evaluation of Oral Epigallocatechin Gallate Treatment for Low-grade Cervical Lesions L-SIL Associated With Human Papilloma Virus HPV Infection
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EGCG-HPV
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
Detailed Description:
Human papilloma virus HPV infection is the most widespread infection worldwide among the sexually active population Papillomaviruses are a very large and heterogeneous family of double-stranded DNA viruses 8kb They have no envelope and have icosahedral symmetry Their viral genome is divided into two regions defined as 1 early and 2 late The early genes encode the early proteins E1 E2 E4 E5 E6 E7 necessary for viral DNA replication and cellular transformation The late genes encode the late proteins L1 L2 which serve for the formation of the viral capsid HPV viruses are classified based on their oncogenicity Those at low risk are associated with proliferative lesions generally benign of the skin and mucous membranes The clinical manifestations include common flat and plantar warts genital and flat condylomata acuminata which are the result of sexual transmission of the virus and which arise on the penis anus female genitalia urethra perianal area and straight High-risk HPVs on the other hand are those that integrate into the hosts genome and cause lesions that can evolve into carcinoma over time However it has recently been shown that even viruses normally defined as low risk can cause precancerous lesions in the case of tumors of the vulva vagina penis and anus In 80 of cases the infection resolves spontaneously within two years however in 20 of cases the infection persists and causes the onset of lesions of varying degrees which over time can evolve into neck cancer of the uterus in women or penile cancer in men In fact if HPV is now recognized as the etiological agent of cervical cancer in 997 of cases it is estimated that it is also responsible for 50 of penile tumors and 26-30 of cord tumors oral
Persistence therefore represents an oncological risk factor for those who contract the infection since if the infection persists for over a year there is a high probability that the viral DNA integrates into the hosts genome Integration involves the constitutive expression of some viral oncoproteins E6E7 that block the activity of host tumor suppressor genes p53pRB The blockade of tumor suppressors in turn stimulates an uncontrolled proliferation of lesions which due to a failure to activate the inhibitory regulatory processes of our organism leads to tumor development
In the case of lesions classified as low grade L-SIL the common practice is to check the patient after six months while in the case of lesions classified as high grade H-SIL the therapeutic standard is represented by the surgical removal of these lesions However removal of the lesion does not guarantee total eradication of the infection as the virus could persist in the adjacent healthy mucosa Currently there are no treatments against HPV infection nor against the persistence of the virus Various types of therapies are associated with primary vaccination and secondary screening programs prevention programs for the treatment of clinical manifestations induced by the virus such as warts Among the treatments that are used as normal clinical practice in the field of HPV infections also for the treatment of warts those based on epigallocatechin gallate EGCG represent a novelty that has been proven to be safe and effective
Epigallocatechin gallate EGCG the main polyphenolic component of green tea has antioxidant anti-inflammatory and anticancer properties Its action has also been extensively tested on cervical cancer lines on which EGCG exerts an antiproliferative and pro-apoptotic action in a dose-dependent manner A recent study demonstrated that EGCG increases the expression levels of p53 protein and reduces the levels of viral oncoproteins E6E7 A randomized clinical trial has also highlighted how treatment with EGCG has a chemo-preventive action on the progression of lesions in HPV-positive women with lesions of various degrees leading to a reduction in the degree of the lesions themselves
Considering these elements 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
Persistence therefore represents an oncological risk factor for those who contract the infection since if the infection persists for over a year there is a high probability that the viral DNA integrates into the hosts genome Integration involves the constitutive expression of some viral oncoproteins E6E7 that block the activity of host tumor suppressor genes p53pRB The blockade of tumor suppressors in turn stimulates an uncontrolled proliferation of lesions which due to a failure to activate the inhibitory regulatory processes of our organism leads to tumor development
In the case of lesions classified as low grade L-SIL the common practice is to check the patient after six months while in the case of lesions classified as high grade H-SIL the therapeutic standard is represented by the surgical removal of these lesions However removal of the lesion does not guarantee total eradication of the infection as the virus could persist in the adjacent healthy mucosa Currently there are no treatments against HPV infection nor against the persistence of the virus Various types of therapies are associated with primary vaccination and secondary screening programs prevention programs for the treatment of clinical manifestations induced by the virus such as warts Among the treatments that are used as normal clinical practice in the field of HPV infections also for the treatment of warts those based on epigallocatechin gallate EGCG represent a novelty that has been proven to be safe and effective
Epigallocatechin gallate EGCG the main polyphenolic component of green tea has antioxidant anti-inflammatory and anticancer properties Its action has also been extensively tested on cervical cancer lines on which EGCG exerts an antiproliferative and pro-apoptotic action in a dose-dependent manner A recent study demonstrated that EGCG increases the expression levels of p53 protein and reduces the levels of viral oncoproteins E6E7 A randomized clinical trial has also highlighted how treatment with EGCG has a chemo-preventive action on the progression of lesions in HPV-positive women with lesions of various degrees leading to a reduction in the degree of the lesions themselves
Considering these elements 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None