Precancerous Cervical Lesion
Conditions
Keywords
Human papillomavirus, High-grade squamous intraepithelial lesion, Methylation, Cervical cancer screening, Triage, Adenocarcinoma in Situ, Cytology
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 Women who meet the clinical endpoint (i.e. histopathologically confirmed ≥CIN2 after baseline colposcopy/biopsy) are withdrawn from the study.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.
Interventions
DIAGNOSTIC_TESTMethylation Test
Participants who aged 25-65 years with high-risk HPV infection are recruited.To start with,cervical exfoliated cells are collected, coded (according to the actual enrollment sequence), and stored in the pathology department where methylation testing is performed.In addition,patients will underwent colposcopy and biopsy. Patients are followed up by cytology, high-risk HPV and methylation tests at 6 and 12 months after enrollment.Cervical conization and hysterectomy will be taken if necessary according to histopathological results. The clinical endpoint is reached when CIN2+ is confirmed by histopathological result.
Sponsors
Peking Union Medical College Hospital
Chengdu Women's and Children's Central Hospital
Guangdong Women and Children Hospital
Second Hospital of Jilin University
First Affiliated Hospital of Xinjiang Medical University
Third Affiliated Hospital of Zhengzhou University
Obstetrics & Gynecology Hospital of Fudan University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE
Intervention model description
Women who aged 25 to 65 years are screened for cervical cancer and they are all positive of high-risk HPV.
Eligibility
Sex/Gender
FEMALE
Age
25 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The sensitivity and specificity of methylation test in detecting CIN2+. | From date of enrollment until the date of first documented CIN2+,assessed up to 12 months | The primary variable of methylation test are as follows:clinical sensitivity, clinical specificity, positive predictive value, negative predictive value, positive likelihood ratio, negative likelihood ratio, positive coincidence rate, and negative coincidence rate. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| KAPPA value of methylation test. | From date of enrollment until the date of first documented CIN2+,assessed up to 12 months | KAPPA value is the secondary variable of methylation test which need to meet statistical criteria. |
Countries
China
Contacts
Primary ContactLong Sui, Professor
Backup ContactQing Cong, PHD
Outcome results
None listed