NCT05624827

The Role of FAM19A4 and Hsa-mir-124 Methylation in Predicting Prognosis of Untreated Cervical Intraepithelial Neoplasia 2 (CIN 2)

Status unknown NA Last updated 22 November 2022

What this trial tests

NA trial testing Testing DNA methylation test for predicting prognosis of untreated CIN 2 in Cervical Intraepithelial Neoplasia Grade 2 in 100 participants. Status unknown.

Timeline

1 September 2021

Primary endpoint
1 September 2023

1 May 2024

Quick facts

Lead sponsor	University Medical Centre Maribor
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	diagnostic
Enrollment	100
Start date	1 September 2021
Primary completion	1 September 2023
Estimated completion	1 May 2024
Sites	1 location across Slovenia

Drugs / interventions tested

• Testing DNA methylation test for predicting prognosis of untreated CIN 2

Conditions studied

• Cervical Intraepithelial Neoplasia Grade 2 — all drugs for Cervical Intraepithelial Neoplasia Grade 2 →
• DNA Methylation — all drugs for DNA Methylation →

Sponsor

University Medical Centre Maribor

Who can join

Adults 20 to 36, female only, with Cervical Intraepithelial Neoplasia Grade 2 or DNA Methylation. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

High-risk precancerous cervical lesions are divided into stage 2 and 3 cervical intraepithelial neoplasia (CIN 2 and 3). CIN 3 represents a direct pre-stage of invasive cancer, has a high rate of progression and a high degree of agreement with the final histological diagnosis. In CIN 2 lesions, the rate of agreement with the final histological diagnosis is lower and the rate of spontaneous regression is higher. Due to the higher rate of regression and possible complications after excisional treatment, conservative active monitoring can be considered in selected young CIN 2 patients. A recent meta-analysis reported a high rate of spontaneous clinical regression of CIN 2, particularly in women under 30 years old. There are currently no prospectively validated prognostic biomarkers to determine which CIN 2 will progress to higher grade and which will regress to lower grade of change. Recent research has studied HPV methylation and microbiome analysis as biomarkers. A number of studies have shown that host cell DNA methylation levels in cervical scrapes increase with underlying cervical disease severity and are highest in cervical cancer. DNA methylation involves the covalent binding of a methyl group to the 5´ position of a cytosine molecule in CpG dinucleotides. Besides global hypomethylation, the overall loss of methylation during carcinogenesis, resulting in chromosomal instability, and the silencing of tumour suppressor genes by local hypermethylation of CpG-rich promoter regions contribute to cancer development. Gene promoter methylation can be easily accessed by sensitive, quantitative methylation-specific PCR providing an objective test outcome. The aim of this study was to determine the effect of the methylation rate of two suppressor genes- FAM19A4 and hsa-mir-124 on the rate of CIN 2 regression, persistence or progression in women younger than 36 years (≤35 years old).

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. MicroRNA (miR)-124: A Promising Therapeutic Gateway for Oncology.
   Gourishetti K, Balaji Easwaran V, Mostakim Y, Ranganath Pai KS, et al · · 2023 · cited 9× · PMID 37508353 · DOI 10.3390/biology12070922