Trial reportBMC cancer2015
Comparison of the Roche cobas® 4800 and Digene Hybrid Capture® 2 HPV tests for primary cervical cancer screening in the HPV FOCAL trial.
Trial report in BMC cancer, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 22 papers, 1 of them a synthesis 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
22 citing papers in PubMed, 1 synthesis or guideline pooled it, 53 citations in OpenAlex.
- Pooled it
- Human papillomavirus-based screening at extended intervals missed fewer cervical precancers than cytology in the HPV For Cervical Cancer (HPV FOCAL) trial.International journal of cancer · 2022Trial
- 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
- Disease detection and resource use in the safety and control arms of the HPV FOCAL cervical cancer screening trial.British journal of cancer · 2016Trial
- HPV Prevalence in the Dutch cervical cancer screening population (DuSC study): HPV testing using automated HC2, cobas and Aptima workflows.BMC cancer · 2016Trial
- Review
- Distinct clinicopathological features and treatment differences in breast cancer patients of young age.Scientific reports · 2025Article
- Comparison of the SureXFrontiers in oncology · 2025Article
- The Role of p16/Ki67 Dual Staining in Cervical Cancer Screening.Current issues in molecular biology · 2023Review
- Development of a simplified and cost-effective sample preparation method for genotyping of human papillomavirus by next-generation sequencing.Archives of virology · 2023Article
- High-Risk Human Papillomavirus Detection via CobasViruses · 2022Article
- Clinical performance of the Roche Cobas 4800 HPV test for primary cervical cancer screening in a Chinese population.PloS one · 2022Article
- Article
- A community-based approach to cervical cancer prevention in western Kenya: An AMPATH feasibility project.SAGE open medicine · 2022Article
- Long-term cervical precancer outcomes after a negative DNA- or RNA-based human papillomavirus test result.American journal of obstetrics and gynecology · 2021Article
- Screening for the prevention and early detection of cervical cancer: protocol for systematic reviews to inform Canadian recommendations.Systematic reviews · 2021Article
- p16/Ki-67 dual-stained cytology used for triage in cervical cancer opportunistic screening.Chinese journal of cancer research = Chung-kuo yen cheng yen chiu · 2020Article
- High-risk human papillomavirus testing as a primary screening for cervical cancer: position statement by the Korean Society of Obstetrics and Gynecology and the Korean Society of Gynecologic Oncology.Journal of gynecologic oncology · 2020Article
- Machine Learning Interpretation of Extended Human Papillomavirus Genotyping by Onclarity in an Asian Cervical Cancer Screening Population.Journal of clinical microbiology · 2019Article
- Evaluation and validation of HPV real-time PCR assay for the detection of HPV DNA in oral cytobrush and FFPE samples.Scientific reports · 2018Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
9 authors at 3 institutions in 1 country.
Funding
Abstract
backgroundHPV FOCAL is a randomized trial (ISRCTN79347302, registered 20 Apr 2007) comparing high-risk (hr) HPV testing vs. liquid-based cytology (LBC) for cervical cancer screening of women aged 25-65. We compared the Digene Hybrid Capture® 2 High-Risk HPV DNA Test® (HC2) and the Roche cobas® 4800 HPV Test (COBAS) for primary screening.
methodsWomen (n=6,172) were screened at baseline by HC2 and COBAS and by LBC 24 months later. We assessed HPV genotyping and reflex LBC for colposcopy triage of baseline HPV positive women.
resultsOverall HC2/COBAS agreement was 96.1% (kappa 0.75) and positive agreement was 77.5%. Baseline CIN2 and CIN3+ rates based on HPV screening were 8.6/1,000 and 6.6/1,000 respectively; 24 month rates were 0.7/1,000 and 0.4/1,000 (LBC screening). HC2 and COBAS were concordant positive for 91% of round 1 CIN2 and 98% of CIN3+. CIN3+ was significantly associated with HPV 16 (Odds Ratio [OR] 5.11; 95% confidence interval [CI] 2.30, 11.37), but not HPV 18 (OR 2.62; 95% CI 0.73, 9.49), vs. non-HPV 16/18 HPV at baseline. There was no significant association between HPV genotype and CIN2. CIN3+ was significantly more likely for high-grade (OR 5.99; 95% CI 2.53, 14.18), but not low-grade (OR 0.54; 95% CI 0.20, 1.49), vs. negative LBC. No significant association was observed between LBC grade and CIN2. HPV 16 and 18 were associated with 33% of CIN2 and 68% of CIN3+ identified at baseline.
conclusionsFor hrHPV positive women, abnormal reflex LBC is appropriate for colposcopy triage. In addition, immediate referral of women with HPV 16/18 and normal cytology may allow for earlier detection of CIN2+ lesions which would not be detected until after follow-up testing.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.