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MTTRIHPWClinical Validation of ASTN1, DLX1, ITGA4, RXFP3, SOX17, ZNF671 Methylation in HPV Positive Women: a Multi-center RCT From China

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What is being tested

Methylation Test

Diagnostic Test
Who is being recruted

Squamous Intraepithelial Lesions+7

+ Adenocarcinoma

+ Carcinoma

From 25 to 65 Years
See all eligibility criteria
How is the trial designed

Screening Study

Interventional
Study Start: April 2024
See protocol details

Summary

Principal SponsorObstetrics & Gynecology Hospital of Fudan University
Study ContactLong Sui, ProfessorMore contacts
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

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.

Official TitleClinical Validation of ASTN1, DLX1, ITGA4, RXFP3, SOX17, ZNF671 Methylation in HPV Positive Women: a Multi-center RCT From China
NCT06366516
Principal SponsorObstetrics & Gynecology Hospital of Fudan University
Study ContactLong Sui, ProfessorMore contacts
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

10000 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Screening Study

Screening studies test new methods to find diseases or risk factors early—before any symptoms appear. This helps catch health issues sooner, when they may be easier to treat.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

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

Squamous Intraepithelial LesionsAdenocarcinomaCarcinomaCarcinoma in SituNeoplasmsNeoplasms by Histologic TypeNeoplasms, Glandular and EpithelialPathological Conditions, Signs and SymptomsMorphological and Microscopic FindingsAdenocarcinoma in Situ

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.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Ten thousand women were recruited who aged 25-65 years and they are positive for high-risk HPV.

Study 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

Suspended

Obstetrics and Gynecology Hospital of Fudan University

Shanghai, ChinaOpen Obstetrics and Gynecology Hospital of Fudan University in Google Maps
Recruiting soonOne Study Center