To hear about similar clinical trials, please enter your email below
Trial Title:
Role of Methylation Test Triage in HPV Positive Women
NCT ID:
NCT06366516
Condition:
Precancerous Cervical Lesion
Conditions: Keywords:
Human papillomavirus
High-grade squamous intraepithelial lesion
Methylation
Cervical cancer screening
Triage
Adenocarcinoma in Situ
Cytology
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
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
Masking:
None (Open Label)
Intervention:
Intervention type:
Diagnostic Test
Intervention name:
Methylation Test
Description:
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.
Arm group label:
Women aged 25-65 years with high-risk HPV infection.
Other name:
Liquid-based Cytology Test
Other name:
High-risk HPV test
Other name:
Colposcopy
Other name:
Biopsy
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≥CIN2 after baseline colposcopy/biopsy) are withdrawn from the study.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.
Criteria for 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
Gender:
Female
Gender based:
Yes
Gender description:
The aim of this study is to evaluate the value of methylation test in high-risk HPV
positive women who aged 25 to 65 years for detecting high-grade cervical lesions and
cervical cancer.
Minimum age:
25 Years
Maximum age:
65 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Obstetrics and Gynecology Hospital of Fudan University
Address:
City:
Shanghai
Zip:
200011
Country:
China
Contact:
Last name:
Long Sui, Professor
Phone:
0086-021-33189900
Email:
suilong@fudan.edu.cn
Contact backup:
Last name:
Qing Cong, PHD
Phone:
0086-021-33189900
Email:
qingcong@fudan.edu.cn
Start date:
April 2024
Completion date:
February 2026
Lead sponsor:
Agency:
Obstetrics & Gynecology Hospital of Fudan University
Agency class:
Other
Collaborator:
Agency:
Peking Union Medical College Hospital
Agency class:
Other
Collaborator:
Agency:
Chengdu Women's and Children's Central Hospital
Agency class:
Other
Collaborator:
Agency:
Guangdong Women and Children Hospital
Agency class:
Other
Collaborator:
Agency:
Second Hospital of Jilin University
Agency class:
Other
Collaborator:
Agency:
First Affiliated Hospital of Xinjiang Medical University
Agency class:
Other
Collaborator:
Agency:
Third Affiliated Hospital of Zhengzhou University
Agency class:
Other
Source:
Obstetrics & Gynecology Hospital of Fudan University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06366516
