ArticleGynecologic oncology2016
Validation of the FAM19A4/mir124-2 DNA methylation test for both lavage- and brush-based self-samples to detect cervical (pre)cancer in HPV-positive women.
Article in Gynecologic oncology, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 64 papers, 3 of them syntheses that pooled it.
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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
64 citing papers in PubMed, 3 syntheses or guidelines pooled 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
- Overview of miRNAs for the non-invasive diagnosis of endometriosis: evidence, challenges and strategies. A systematic review.Einstein (Sao Paulo, Brazil) · 2021Pooled it
- Performance of DNA methylation assays for detection of high-grade cervical intraepithelial neoplasia (CIN2+): a systematic review and meta-analysis.British journal of cancer · 2019Pooled it
- Evaluation of a validated methylation triage signature for human papillomavirus positive women in the HPV FOCAL cervical cancer screening trial.International journal of cancer · 2019Trial
- Genome-wide microRNA analysis of HPV-positive self-samples yields novel triage markers for early detection of cervical cancer.International journal of cancer · 2019Trial
- Cervical cancer risk in HPV-positive women after a negative FAM19A4/mir124-2 methylation test: A post hoc analysis in the POBASCAM trial with 14 year follow-up.International journal of cancer · 2018Trial
- Randomised study shows that repeated self-sampling and HPV test has more than two-fold higher detection rate of women with CIN2+ histology than Pap smear cytology.British journal of cancer · 2018Trial
- Oncogenic DNMT3B as a therapeutic target for cervical cancer.Chinese medical journal · 2026Article
- Review
- SOX1/PAX1 Methylation for Triage of HPV-Positive Women in Cervical Cancer Screening: A Cohort Study.BJOG : an international journal of obstetrics and gynaecology · 2026Article
- Targeting epigenetic methylation: emerging diagnosis and therapeutic strategies in cancer.Experimental hematology & oncology · 2026Review
- 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
- DNA Methylation in Cervical Intraepithelial Neoplasia and Cervical Cancer: Triage and Management.Current topics in microbiology and immunology · 2026Review
- CIN2 in the Era of Risk-Based Management and HPV Vaccination: Epidemiology, Natural History and Guidelines.Diagnostics (Basel, Switzerland) · 2025Review
- The DNA Methylation MarkerCancers · 2025Article
- Evaluating the Predictive Performance of miR-124-2 and FAM19A4 for Cervical Lesions in a Single Center from Romania: A Prospective Study.Journal of clinical medicine · 2025Article
- The Role of HPV Genotyping, Cytology, and Methylation in the Triage of High-Risk HPV-Positive Patients.Biomedicines · 2025Article
- Comparative evaluation of two DNA methylation assays for triage of hrHPV E6/E7 mRNA-positive women.Frontiers in public health · 2025Article
- Performance ofBMJ open · 2024Observational
4 more citing papers are in PubMed but not listed here.
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Authors and funding
14 authors.
Funding
Abstract
objectivesDNA methylation analysis of cancer-related genes is a promising tool for HPV-positive women to identify those with cervical (pre)cancer (CIN3+) in need of treatment. However, clinical performance of methylation markers can be influenced by the sample type utilized. We describe a multiplex quantitative methylation-specific PCR that targets FAM19A4 and mir124-2 loci, to detect CIN3+ using both HPV-positive lavage- and brush self-samples.
methodsWe determined methylation thresholds for clinical classification using HPV-positive training sets comprising lavage self-samples of 182 women (including 40 with CIN3+) and brush self-samples of 224 women (including 61 with CIN3+). Subsequently, independent HPV-positive validation sets of 389 lavage self-samples (including 78 with CIN3+), and 254 brush self-samples (including 72 with CIN3+) were tested using the preset thresholds. Furthermore, the clinical performance of combined methylation analysis and HPV16/18 genotyping was determined.
resultsTraining set analysis revealed similar FAM19A4 and mir124-2 thresholds for both self-sample types to yield highest CIN3+ sensitivity at 70% specificity. Validation set analysis resulted in a CIN3+ sensitivity of 70.5% (95%CI: 60.4-80.6) at a specificity of 67.8% (95%CI: 62.7-73.0) for lavage self-samples, and a CIN3+ sensitivity of 69.4% (95%CI: 58.8-80.1) at a 76.4% (95%CI: 70.2-82.6) specificity for brush self-samples. In combination with HPV16/18 genotyping, CIN3+ sensitivity and specificity were 88.5% (95%CI: 81.4-95.6) and 46.0% (95%CI: 40.4-51.5) for lavage self-samples, and 84.7% (95%CI: 76.4-93.0) and 54.9% (95%CI: 47.7-62.2) for brush self-samples.
conclusionsFAM19A4/mir124-2 methylation analysis performs equally well in HPV-positive lavage- and brush self-samples to identify women with CIN3+. In combination with HPV16/18 genotyping, significantly higher CIN3+ sensitivities are obtained, at decreased specificity.
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