Trial reportInternational journal of cancer2019
Evaluation of a validated methylation triage signature for human papillomavirus positive women in the HPV FOCAL cervical cancer screening trial.
Trial report in International journal of cancer, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 43 papers, 3 of them syntheses that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
43 citing papers in PubMed, 3 syntheses or guidelines pooled it.
- Meta-analysis of the diagnostic value of SOX1 methylation in different types of cervical cancer.World journal of surgical oncology · 2025Pooled it
- DNA methylation as a triage marker for colposcopy referral in HPV-based cervical cancer screening: a systematic review and meta-analysis.Clinical epigenetics · 2023Pooled it
- The Role of Methylation of Host and/or Human Papillomavirus (HPV) DNA in Management of Cervical Intraepithelial Neoplasia Grade 2 (CIN2) Lesions.International journal of molecular sciences · 2023Pooled it
- PAX1/SOX1 DNA Methylation Versus Cytology and HPV16/18 Genotyping for the Triage of High-Risk HPV-Positive Women in Cervical Cancer Screening: Retrospective Analysis of Archival Samples.BJOG : an international journal of obstetrics and gynaecology · 2025Trial
- DNA methylation for cervical cancer screening: a training set in China.Clinical epigenetics · 2020Trial
- HPV-Driven Cervical Carcinogenesis: Genetic and Epigenetic Mechanisms and Diagnostic Approaches.International journal of molecular sciences · 2026Review
- Diagnostic Accuracy of DNA Methylation Markers for Detecting Cervical Precancer and Cervical Cancer: A Systematic Review and Meta-analysis.Archives of academic emergency medicine · 2026Review
- Article
- DNA methylation signatures of cervical pre-invasive and invasive disease: An epigenome-wide association study.International journal of cancer · 2025Article
- The triage role of cytological DNA methylation in women with non-16/18, specifically genotyping high-risk HPV infection.British journal of cancer · 2025Article
- Targeting HPV for the prevention, diagnosis, and treatment of cervical cancer.Journal of molecular cell biology · 2025Review
- Human papillomavirus-mediated cervical cancer: epigenetic interplay and clinical implications.Frontiers in microbiology · 2025Review
- Performance ofBMJ open · 2024Observational
- DNA methylation as a triage tool for cervical cancer screening - A meeting report.Preventive medicine reports · 2024Review
- Discovery and technical validation of high-performance methylated DNA markers for the detection of cervical lesions at risk of malignant progression in low- and middle-income countries.Clinical epigenetics · 2024Article
- Human papillomavirus (HPV) DNA methylation changes in HPV-associated head and neck cancer.Carcinogenesis · 2024Article
- Performance of Human Gene EPB41L3 and HPV 16/18 Viral DNA Methylation to Triage hrHPV-Positive Women.Vaccines · 2023Article
- The Role of p16/Ki67 Dual Staining in Cervical Cancer Screening.Current issues in molecular biology · 2023Review
- Assessing the risk of cervical neoplasia in the post-HPV vaccination era.International journal of cancer · 2023Review
- Molecular triaging options for women testing HPV positive with self-collected samples.Frontiers in oncology · 2023Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
14 authors.
Funding
Abstract
Human papillomavirus (HPV)-based cervical cancer screening requires triage of HPV positive women to identify those at risk of cervical intraepithelial neoplasia grade 2 (CIN2) or worse. We conducted a blinded case-control study within the HPV FOCAL randomized cervical cancer screening trial of women aged 25-65 to examine whether baseline methylation testing using the S5 classifier provided triage performance similar to an algorithm relying on cytology and HPV genotyping. Groups were randomly selected from women with known HPV/cytology results and pathology outcomes. Group 1: 104 HPV positive (HPV+), abnormal cytology (54 CIN2/3; 50 <CIN2); Group 2: 103 HPV+, normal cytology with HPV persistence at 12 mo. (53 CIN2/3; 50 <CIN2); Group 3: 50 HPV+, normal cytology with HPV clearance at 12 mo. (assumed <CIN2), total n=257. For the combined groups, S5 risk score CIN2/3 relative sensitivity, specificity and positive predictive value (PPV) were compared with other triage approaches. Methylation showed a highly significant increasing trend with disease severity. For CIN3, S5 relative sensitivity and specificity were: 93.2% (95%CI: 81.4-98.0) and 41.8% (35.2-48.8), compared to 86.4% (75.0-95.7) and 49.8% (43.1-56.6) respectively for combined abnormal cytology/HPV16/18 positivity (differences not statistically significant at 5% level); adjusted PPVs were 18.2% (16.2-20.4) and 19.3% (16.6-22.2) respectively. S5 was also positive in baseline specimens from eight cancers detected during or after trial participation. The S5 methylation score had high sensitivity and PPV for CIN3, compatible with US and European thresholds for colposcopy referral. Methylation signatures can identify most HPV positive women at increased risk of cervical cancer from their baseline screening specimens.
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