MTTRIHPWClinical Validation of ASTN1, DLX1, ITGA4, RXFP3, SOX17, ZNF671 Methylation in HPV Positive Women: a Multi-center RCT From China
Methylation Test
Squamous Intraepithelial Lesions+7
+ Adenocarcinoma
+ Carcinoma
Screening Study
Summary
Study start date: April 1, 2024
Actual date on which the first participant was enrolled.This study focuses on the clinical validation of certain genetic markers in women who have tested positive for HPV, the virus often associated with cervical cancer. The research aims to determine if these specific markers can help better predict the progression to more severe cervical conditions. This is particularly important for women who might be at risk of developing significant cervical changes, as it could lead to earlier and more precise interventions, ultimately improving their health outcomes. The study is conducted in two phases: an initial phase and a follow-up phase after one year. Participants undergo a series of tests, including checking for HPV, cellular changes through cytology, and genetic marker methylation tests. If initial tests show significant changes, participants may undergo more detailed examination through colposcopy and biopsy. However, if there are no concerning findings, participants continue with follow-up testing at six months and one year. The study does not mention specific risks, but ongoing monitoring ensures that any potential progression of the disease is detected early.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.10000 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Screening Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Female
Biological sex of participants that are eligible to enroll.From 25 to 65 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Inclusion Criteria: * aged 25\~65 years undergoing cervical cancer screening * normal for cytology and positive for hrHPV * informed consent was obtained Exclusion Criteria: * pregnant * with a known history of ablation or treatment with cervical excision within 12 months * hysterectomy * chemoradiotherapy * planning to participate or taking part in another cancer screening, treatment, or vaccination study * do not meet the inclusion criteria * give up the trial or naturally dropped out of the follow-up during the observation process * people who asked to withdraw
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Obstetrics and Gynecology Hospital of Fudan University
Shanghai, ChinaOpen Obstetrics and Gynecology Hospital of Fudan University in Google Maps