Clinical trial NCT06366516: Role of Methylation Test Triage in HPV Positive Women
Official title: Clinical Validation of ASTN1, DLX1, ITGA4, RXFP3, SOX17, ZNF671 Methylation in HPV Positive Women: a Multi-center RCT From China
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Precancerous Cervical Lesion
Keywords: Human papillomavirus
High-grade squamous intraepithelial lesion
Methylation
Cervical cancer screening
Triage
Adenocarcinoma in Situ
Cytology
Lead sponsor: Obstetrics & Gynecology Hospital of Fudan University
Sponsor class: OTHER
Collaborators: name: Peking Union Medical College Hospital
name: Chengdu Women's and Children's Central Hospital
name: Guangdong Women and Children Hospital
name: Second Hospital of Jilin University
name: First Affiliated Hospital of Xinjiang Medical University
name: Third Affiliated Hospital of Zhengzhou University
First posted: 2024-04-16
Enrollment: 10000
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Women who aged 25 to 65 years are screened for cervical cancer and they are all positive of high-risk HPV.
Primary purpose: SCREENING

Brief summary: The pathological results were used as the gold standard in this study and the investigators analyze the diagnostic value of six gene methylation status (ASTN1 DLX1, ITGA4, RXFP3, SOX17, ZNF671) in triaging high-risk human papillomavirus infection. The sensitivity and specificity of methylation test and cytology in the diagnosis of high-grade cervical lesions are compared in order to providing new methods and basis in improving the accuracy of cervical cancer screening.

Detailed description: The study is divided into two phases, a baseline (cross-sectional) phase and a 1-year follow-up phase. Women who meet the clinical endpoint (i.e. histopathologically confirmed ≥CIN2 after baseline colposcopy/biopsy) are withdrawn from the study. Participants who do not meet the primary endpoint/treat at baseline will invited to participate in the follow-up phase of the trial. Participants included in the follow-up phase are underwent HPV, cytology, and methylation tests at 6 months and 1 year after baseline.Similar to the baseline phase,participants were referred to colposcopy/biopsy if any of the cytology and HPV tests result is positive.

Eligibility 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

Primary outcomes:
measure: The sensitivity and specificity of methylation test in detecting CIN2+.
timeFrame: From date of enrollment until the date of first documented CIN2+,assessed up to 12 months
Secondary outcomes:
measure: KAPPA value of methylation test.
timeFrame: From date of enrollment until the date of first documented CIN2+,assessed up to 12 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Obstetrics and Gynecology Hospital of Fudan University
state: Shanghai
Study officials:
affiliation: Obstetrics & Gynecology Hospital of Fudan University
name: Long Sui, Professor
role: STUDY_CHAIR
affiliation: Peking Union Medical College Hospital
name: Lan Zhu, Professor
role: STUDY_CHAIR
References:
citation: Kremer WW, Steenbergen R, Heideman D, Kenter GG, Meijer C. The use of host cell DNA methylation analysis in the detection and management of women with advanced cervical intraepithelial neoplasia: a review. BJOG. 2021 Feb;128(3):504-514. doi: 10.1111/1471-0528.16395. Epub 2020 Aug 9.
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