Observational studyInternational journal of cancer2022
Clinical validation of p16/Ki-67 dual-stained cytology triage of HPV-positive women: Results from the IMPACT trial.
Observational study in International journal of cancer, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06366516 (Clinical Validation of ASTN1, DLX1, ITGA4, RXFP3, SOX17, ZNF671 Methylation in HPV Positive Women), which is not on this map. Cited by 44 papers.
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.
Clinical Validation of ASTN1, DLX1, ITGA4, RXFP3, SOX17, ZNF671 Methylation in HPV Positive Women: a Multi-center RCT From China
Who cites it
44 citing papers in PubMed, 62 citations in OpenAlex.
- Predictive Contribution of p16 Beyond HPV Genotype in the Histopathologic Detection of CIN2+ Lesions: A Real-World Cervical Biopsy Cohort Study.Diagnostics (Basel, Switzerland) · 2026Article
- Clinical Significance of High-Risk HPV Positivity with Negative Cytology: Can Further Evaluation Be Safely Delayed?Medicina (Kaunas, Lithuania) · 2026Observational
- Implementation and impact of primary HPV testing in cervical cancer screening: Historical perspectives and institutional experience at a large academic medical center.Cancer cytopathology · 2026Review
- How to evaluate and select cervical screening and triage tests in vaccinated populations.Journal of the National Cancer Institute. Monographs · 2026Article
- Human Papillomavirus Infection Across the Immunological Spectrum: Clinical Expression, Colposcopic Challenges, and Therapeutic Implications.Diagnostics (Basel, Switzerland) · 2026Review
- Health care policy trial of primary human papillomavirus-based cervical screening in Denmark: Comparison of three triage algorithms.International journal of cancer · 2026Article
- 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
- Vaginal Microbiota Composition and HPV Genotype-Specific CIN2+ Risk: A Cross-Sectional Study.Diagnostics (Basel, Switzerland) · 2026Article
- Cost-effectiveness of Including p16/Ki-67 Dual Staining in the Detection of Cervical Lesions in Colombia, 2024Revista colombiana de obstetricia y ginecologia · 2026Article
- Long-Term Prospective Cohort Study of Cervical Cancer Screening Using Triage of Women Who Are Human Papillomavirus-Positive With Dual Stain and Human Papillomavirus Genotyping.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2026Observational
- Cost-utility of screening with liquid cytology or p16/Ki67 dual stain in women identified in cervical cancer triage with non 16/18 HR-HPV.International journal of technology assessment in health care · 2026Article
- Informative High-Risk HPV Genotyping in Cervical Cancer Screening: Integrated Analysis of Cytology and p16/Ki67 Dual Staining.Cancers · 2026Article
- Review
- Prospective Evaluation of Cytology, CINtecJournal of clinical medicine · 2026Article
- Comparison of ThinPrep cytology and high-risk human papillomavirus testing with different triage protocols for cervical cancer screening.American journal of translational research · 2026Article
- Article
- Cost-effectiveness analysis of reflex p16/Ki-67 dual-stained cytology in HPV partial genotyping screening in Singapore.Journal of gynecologic oncology · 2025Article
- GYPC methylation performance in detecting cervical (pre)cancer in high-risk HPV-positive women using liquid-based cervical scrapes.Infectious agents and cancer · 2025Article
- Significance of Genotype-Specific High-Risk Human Papillomavirus Testing in Cervical Cancer Screening: A Hospital-Based Study.Journal of medical virology · 2025Article
- Advancements in Cervical Cancer Screening: Enhancing HPV Testing and Triage Strategies for Improved Risk Assessment.Biomedicines · 2025Review
Corrections and comments
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Authors and funding
7 authors at 5 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Triage strategies are needed for primary human papillomavirus (HPV)-based cervical cancer screening to identify women requiring colposcopy/biopsy. We assessed the performance of p16/Ki-67 dual-stained (DS) immunocytochemistry to triage HPV-positive women and compared it to cytology, with or without HPV16/18 genotyping. A prospective observational screening study enrolled 35 263 women aged 25 to 65 years at 32 U.S. sites. Cervical samples had HPV and cytology testing, with colposcopy/biopsy for women with positive tests. Women without cervical intraepithelial neoplasia Grade 2 or worse (≥CIN2) at baseline (n = 3876) were retested after 1 year. In all, 4927 HPV-positive women with valid DS results were included in this analysis. DS sensitivity for ≥CIN2 and ≥CIN3 at baseline was 91.2% (95% confidence interval [CI]: 86.8%-94.2%) and 91.9% (95% CI: 86.1%-95.4%), respectively, in HPV16/18-positive women and 83.0% (95% CI: 78.4%-86.8%) and 86.0% (95% CI: 77.5%-91.6%) in women with 12 "other" genotypes. Using DS alone to triage HPV-positive women showed significantly higher sensitivity and specificity than HPV16/18 genotyping with cytology triage of 12 "other" genotypes, and substantially higher sensitivity but lower specificity than using cytology alone. The risk of ≥CIN2 was significantly lower in HPV-positive, DS-negative women (3.6%; 95% CI: 2.9%-4.4%), compared to triage-negative women using HPV16/18 genotyping with cytology for 12 "other" genotypes (7.4%; 95% CI: 6.4%-8.5%; P < .0001) or cytology alone (7.5%; 95% CI: 6.7%-8.4%; P < .0001). DS showed better risk stratification than cytology-based strategies and provided high reassurance against pre-cancers both at baseline and at 1-year follow-up, irrespective of the HPV genotype. DS allows for the safe triage of primary screening HPV-positive women.
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