Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Peking Union Medical College Hospital | OTHER |
| Chengdu Women's and Children's Central Hospital | OTHER |
| Guangdong Women and Children Hospital | OTHER |
Not provided
Not provided
Not provided
Not provided
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.
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 Women who meet the clinical endpoint (i.e. histopathologically confirmed ≥CIN2 after baseline colposcopy/biopsy) are withdrawn from the study.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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Women aged 25-65 years with high-risk HPV infection. | Experimental | Ten thousand women were recruited who aged 25-65 years and they are positive for high-risk HPV. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Methylation Test | Diagnostic 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. |
| Measure | Description | Time Frame |
|---|---|---|
| The sensitivity and specificity of methylation test in detecting CIN2+. | 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. | From date of enrollment until the date of first documented CIN2+,assessed up to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| KAPPA value of methylation test. | KAPPA value is the secondary variable of methylation test which need to meet statistical criteria. | From date of enrollment until the date of first documented CIN2+,assessed up to 12 months |
Not provided
Inclusion Criteria:
Exclusion Criteria:
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.
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Long Sui, Professor | Contact | 0086-021-33189900 | suilong@fudan.edu.cn | |
| Qing Cong, PHD | Contact | 0086-021-33189900 | qingcong@fudan.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Long Sui, Professor | Obstetrics & Gynecology Hospital of Fudan University | Study Chair |
| Lan Zhu, Professor | Peking Union Medical College Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Obstetrics and Gynecology Hospital of Fudan University | Shanghai | Shanghai Municipality | 200011 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32619334 | Background | 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. | |
| 32745170 | Result | Giorgi Rossi P, Carozzi F, Ronco G, Allia E, Bisanzi S, Gillio-Tos A, De Marco L, Rizzolo R, Gustinucci D, Del Mistro A, Frayle H, Confortini M, Iossa A, Cesarini E, Bulletti S, Passamonti B, Gori S, Toniolo L, Barca A, Bonvicini L, Mancuso P, Venturelli F, Benevolo M; the New Technology for Cervical Cancer 2 Working Group. p16/ki67 and E6/E7 mRNA Accuracy and Prognostic Value in Triaging HPV DNA-Positive Women. J Natl Cancer Inst. 2021 Mar 1;113(3):292-300. doi: 10.1093/jnci/djaa105. |
Not provided
Not provided
All collected data from participants will be shared，including age of patients, the results of cytological examination/high-risk HPV genotyping/methylation test/histopathological, colposcopy impression, and whether cervical conization or hysterectomy were performed before.
Starting 6 months after publication
We will apply for a web address to upload all collected clinical data and trial results. The public can send email or request access to the web if any of them needed. After waiting for the principal investigator's consent, the data would be shared by browsing the website.
Not provided
Not provided
| ID | Term |
|---|---|
| D000081483 | Squamous Intraepithelial Lesions |
| D065311 | Adenocarcinoma in Situ |
| ID | Term |
|---|---|
| D065308 | Morphological and Microscopic Findings |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
Not provided
Not provided
| ID | Term |
|---|---|
| D003127 | Colposcopy |
| D001706 | Biopsy |
| ID | Term |
|---|---|
| D003944 | Diagnostic Techniques, Obstetrical and Gynecological |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D004724 | Endoscopy |
Not provided
Not provided
| Second Hospital of Jilin University |
| OTHER |
| First Affiliated Hospital of Xinjiang Medical University | OTHER |
| Third Affiliated Hospital of Zhengzhou University | OTHER |
Women who aged 25 to 65 years are screened for cervical cancer and they are all positive of high-risk HPV.
Not provided
Not provided
Not provided
Not provided
|
|
| 35266975 | Result | van den Helder R, Steenbergen RDM, van Splunter AP, Mom CH, Tjiong MY, Martin I, Rosier-van Dunne FMF, van der Avoort IAM, Bleeker MCG, van Trommel NE. HPV and DNA Methylation Testing in Urine for Cervical Intraepithelial Neoplasia and Cervical Cancer Detection. Clin Cancer Res. 2022 May 13;28(10):2061-2068. doi: 10.1158/1078-0432.CCR-21-3710. |
| 37047452 | Result | Dovnik A, Poljak M. The Role of Methylation of Host and/or Human Papillomavirus (HPV) DNA in Management of Cervical Intraepithelial Neoplasia Grade 2 (CIN2) Lesions. Int J Mol Sci. 2023 Mar 30;24(7):6479. doi: 10.3390/ijms24076479. |
| 37894462 | Result | Mazurec K, Trzeszcz M, Mazurec M, Streb J, Halon A, Jach R. Triage Strategies for Non-16/Non-18 HPV-Positive Women in Primary HPV-Based Cervical Cancer Screening: p16/Ki67 Dual Stain vs. Cytology. Cancers (Basel). 2023 Oct 21;15(20):5095. doi: 10.3390/cancers15205095. |
| 32408396 | Result | Yang S, Wu Y, Wang S, Xu P, Deng Y, Wang M, Liu K, Tian T, Zhu Y, Li N, Zhou L, Dai Z, Kang H. HPV-related methylation-based reclassification and risk stratification of cervical cancer. Mol Oncol. 2020 Sep;14(9):2124-2141. doi: 10.1002/1878-0261.12709. Epub 2020 Jun 2. |
| 31490545 | Result | Stoler MH, Baker E, Boyle S, Aslam S, Ridder R, Huh WK, Wright TC Jr. Approaches to triage optimization in HPV primary screening: Extended genotyping and p16/Ki-67 dual-stained cytology-Retrospective insights from ATHENA. Int J Cancer. 2020 May 1;146(9):2599-2607. doi: 10.1002/ijc.32669. Epub 2019 Oct 6. |
| 34536311 | Result | Wright TC Jr, Stoler MH, Ranger-Moore J, Fang Q, Volkir P, Safaeian M, Ridder R. Clinical validation of p16/Ki-67 dual-stained cytology triage of HPV-positive women: Results from the IMPACT trial. Int J Cancer. 2022 Feb 1;150(3):461-471. doi: 10.1002/ijc.33812. Epub 2021 Sep 25. |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D002278 | Carcinoma in Situ |
| D003949 | Diagnostic Techniques, Surgical |
| D019060 | Minimally Invasive Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D013513 | Obstetric Surgical Procedures |
| D013509 | Gynecologic Surgical Procedures |
| D013519 | Urogenital Surgical Procedures |
| D003581 | Cytodiagnosis |
| D003584 | Cytological Techniques |
| D019411 | Clinical Laboratory Techniques |
| D013048 | Specimen Handling |
| D008919 | Investigative Techniques |