ArticleJournal of the National Cancer Institute2013
Screening for cervical cancer precursors with p16/Ki-67 dual-stained cytology: results of the PALMS study.
Article in Journal of the National Cancer Institute, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 99 papers, 1 of them a synthesis 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.
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Who cites it
99 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Comparison of different mRNA testing technologies with HPV DNA testing for predicting ASCUS triage and post-cone excision outcomes: a systematic review and meta-analysis.Systematic reviews · 2026Pooled 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
- Immunocytochemical study of TOP2A and Ki-67 in cervical smears from women under routine gynecological care.Journal of biomedical science · 2016Trial
- Comparison of the Roche cobas® 4800 and Digene Hybrid Capture® 2 HPV tests for primary cervical cancer screening in the HPV FOCAL trial.BMC cancer · 2015Trial
- Clinical Significance of High-Risk HPV Positivity with Negative Cytology: Can Further Evaluation Be Safely Delayed?Medicina (Kaunas, Lithuania) · 2026Observational
- Three Years of Co-Testing 2020-2022: Correlation of Diagnostic Colposcopy with Histology in Cases of Normal Cytology and Persistent High-Risk HPV.Geburtshilfe und Frauenheilkunde · 2026Article
- Comparison of Ex-House and In-House Cytology for the New Cervical Cancer Screening Assessment.Geburtshilfe und Frauenheilkunde · 2026Article
- Human Papillomavirus in Reproductive Health and Pregnancy: Clinical Implications, Outcomes, and a Comprehensive Review of Vaccination.Vaccines · 2026Review
- Prospective Evaluation of Cytology, CINtecJournal of clinical medicine · 2026Article
- Article
- Photodynamic therapy: a promising alternative for high-grade squamous intraepithelial lesion treatment.Frontiers in oncology · 2026Review
- Integrating Biomarkers into Cervical Cancer Screening-Advances in Diagnosis and Risk Prediction: A Narrative Review.Diagnostics (Basel, Switzerland) · 2025Review
- CervicalMethDx: A Precision DNA Methylation Test to Identify Risk of High-Grade Intraepithelial Lesions in Cervical Cancer Screening Algorithms.Cancer prevention research (Philadelphia, Pa.) · 2025Article
- HPV16/HPV58 viral load is non-linearly correlated with cervical lesions and can be used as a triage marker.Infectious agents and cancer · 2025Article
- Advancements in Cervical Cancer Screening: Enhancing HPV Testing and Triage Strategies for Improved Risk Assessment.Biomedicines · 2025Review
- Low-coverage whole-genome sequencing for differentiating cervical cancer from cervical intraepithelial neoplasia and benign diseases.Chromosome research : an international journal on the molecular, supramolecular and evolutionary aspects of chromosome biology · 2025Article
- Publication trends and hotspots for cervical cancer screening biomarker: a bibliometric analysis.Discover oncology · 2025Article
- p16/ki-67 dual stain triage of individuals positive for HPV to detect cervical precancerous lesions.International journal of cancer · 2025Review
- The Value of P16 Protein Detection in the Screening for High-Grade Squamous Intraepithelial and Higher Lesions of the Cervix by the Combined Detection of HR-HPV and TCT.Diagnostic cytopathology · 2025Article
- The role of p16/Ki-67 dual staining in cervical cancer screening and cervical precancerous lesions follow-up.CytoJournal · 2025Article
39 more citing papers are in PubMed but not listed here.
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Authors and funding
18 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundPap cytology is known to be more specific but less sensitive than testing for human papillomavirus (HPV) for the detection of high-grade cervical intraepithelial neoplasia (CIN2+). We assessed whether p16/Ki-67 dual-stained cytology, a biomarker combination indicative of transforming HPV infections, can provide high sensitivity for CIN2+ in screening while maintaining high specificity. Results were compared with Pap cytology and HPV testing.
methodsA total of 27,349 women 18 years or older attending routine cervical cancer screening were prospectively enrolled in five European countries. Pap cytology, p16/Ki-67 immunostaining, and HPV testing were performed on all women. Positive test results triggered colposcopy referral, except for women younger than 30 years with only positive HPV test results. Presence of CIN2+ on adjudicated histology was used as the reference standard. Two-sided bias-corrected McNemar P values were determined.
resultsThe p16/Ki-67 dual-stained cytology positivity rates were comparable with the prevalence of abnormal Pap cytology results and less than 50% of the positivity rates observed for HPV testing. In women of all ages, dual-stained cytology was more sensitive than Pap cytology (86.7% vs 68.5%; P < .001) for detecting CIN2+, with comparable specificity (95.2% vs 95.4%; P = .15). The relative performance of the tests was similar in both groups of women: younger than age 30 and 30 years or older. HPV testing in women 30 years or older was more sensitive than dual-stained cytology (93.3% vs 84.7%; P = .03) but less specific (93.0% vs 96.2%; P < .001).
conclusionsThe p16/Ki-67 dual-stained cytology combines superior sensitivity and noninferior specificity over Pap cytology for detecting CIN2+. It suggests a potential role of dual-stained cytology in screening, especially in younger women where HPV testing has its limitations.
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