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IntroductionCervical cancer remains a significant public health concern in Singapore, with current screening rates at 43%, well below the national target of 70%. In 2019, human papillomavirus (HPV) DNA testing was introduced into the national cervical cancer screening programme, but barriers to participation include embarrassment, privacy concerns and discomfort with clinician-sampled tests. Self-sampled HPV DNA testing offers a promising alternative by providing more privacy and convenience. This study aims to evaluate the impact of including self-sampled HPV DNA testing as an alternative to clinician-sampling on screening uptake, clinical outcomes and cost-effectiveness in primary care.Methods and analysisThis pragmatic, open-label, two-arm randomised controlled trial employs a Zelen design. A total of 650 women aged 30–69 who are due for cervical cancer screening will be recruited from National Healthcare Group Polyclinics in Singapore. Participants will be randomly assigned to either the intervention arm (offering both self-sampling and clinician-sampling) or the usual care arm (clinician-sampling only). The primary outcome is the proportion of participants in each arm detected with high-risk HPV. Secondary outcomes include the proportion of participants in each arm who undergo cervical cancer screening (uptake), are referred for colposcopy and are detected with CIN 2/3 or cervical cancer, as well as cost-effectiveness. Acceptability and feasibility of self-sampling will be evaluated through post-screening questionnaires.Ethics and disseminationEthical approval was granted by the National Healthcare Group Domain Specific Review Board. Study results will be disseminated through peer-reviewed journals, healthcare conferences and shared with policymakers to guide potential inclusion of self-sampling in Singapore’s national cervical cancer screening programme. Findings from this trial will provide crucial evidence for the potential inclusion of self-sampling in Singapore’s national cervical cancer screening programme, which could increase screening rates and improve public health outcomes.Trial registration numberClinicalTrials.gov: NCT06528184.

Purpose: This study compares the detection sensitivity of two separate liquid biopsy sources, cell-free (cf) DNA/RNA and extracellular vesicle (EV)-associated DNA/RNA (EV-DNA/RNA), to identify circulating Human Papilloma Virus (HPV) DNA/RNA in plasma obtained from patients with oropharyngeal squamous cell carcinoma (OPCSCC). We also report on the longitudinal changes observed in HPV-DNA levels in response to treatment. Experimental design: A prospective study was conducted that included 22 patients with locally advanced disease and six patients with metastatic OPCSCC. Twenty-three patients had HPV-related OPCSCC defined by p16 immunohistochemistry. Levels of circulating HPV-DNA and HPV-RNA from plasma-derived cf-DNA/RNA and EV-DNA/RNA were quantified using digital droplet PCR. Results: Circulating HPV-DNA was detected with higher sensitivity in cf-DNA compared to EV-DNA at 91% vs. 42% ( p  = <0.001). Similarly, circulating tumoral HPV-RNA was detected at a higher sensitivity in cf-RNA compared to EV-RNA, at 83% vs. 50% ( p  = 0.0019). In the locally advanced cohort, 100% (n = 16) of HPV-OPCSCC patients demonstrated a reduction in circulating HPV-DNA levels in cf-DNA following curative treatment, with 81% of patients demonstrating complete clearance to undetectable levels. However, in metastatic HPV-OPCSCC patients (n = 4), HPV-DNA levels did not correlate with treatment response. Conclusion: Our study demonstrates that although HPV-DNA/RNA can be detected in EV associated DNA/RNA, cf-DNA/RNA is the more sensitive liquid biopsy medium. As circulating HPV-DNA levels were found to only correlate with treatment response in the locally advanced but not metastatic setting in our small cohort of patients, the use of HPV-DNA as a dynamic biomarker to monitor treatment response requires further evaluation.

Background The World Health Organization has set ambitious goals to eliminate cervical cancer, necessitating evidence on increasing coverage and access to screening and treatment in high-burden areas. We implemented a pilot program to assess the feasibility of obtaining self-collected specimens for high-risk human papillomavirus (hr-HPV) testing in Nzulezo stilt village, a hard-to-reach community in Ghana, and inviting only hr-HPV-positive women to a central location for colposcopy and possible treatment. Subsequently, this study aimed to investigate the prevalence of hr-HPV infection and cervical lesions among the women and to explore factors potentially associated with hr-HPV infection among them. Methods This pilot community-based cross-sectional study utilized data from screening sessions held from 2 to 20 November 2021 with specimens collected by participants using Evalyn brushes. HPV DNA testing was performed using the Sansure MA-6000 platform, while visual inspection utilized the Enhanced Visual Assessment (EVA) mobile colposcope. Univariate and multivariable nominal logistic regression was employed to explore factors associated with hr-HPV positivity. Results Among 100 women screened (mean age, 43.6 ± 14.5 years), the overall hr-HPV prevalence rate was 39.0% (95% CI, 29.4–49.3). The prevalence rates of hr-HPV genotypes were stratified as follows: HPV16–8.0% (95% CI, 3.5–15.2), HPV18–5.0% (95% CI, 1.6–11.2), and other genotype(s) – 31.0% (95% CI, 22.1–41.0). Single-genotype infections with HPV16 and HPV18 were found in 4.0% (95% CI, 1.1–9.9) and 3.0% (95% CI, 0.6–8.5) of women, respectively. Mixed infections were observed in 1.0% (95% CI, 0.0–5.4) for HPV16 + 18, 3.0% (95% CI, 0.6–8.5) for HPV16 +  other type(s), and 1.0% (95% CI, 0.0–5.4) for HPV18 + other type(s). The prevalence of cervical lesions among hr-HPV-positive women screened via colposcopy was 11.4% (95% CI, 3.2–26.7). In the multivariable model, reliance on other sources for medical bill payment was associated with hr-HPV infection (aOR, 0.20; 95% CI, 0.04–0.93), whereas age was not (aOR, 1.02; 95% CI, 0.99–1.05). Conclusions A high hr-HPV infection prevalence was recorded among the women. Utilizing technologies such as self-sampling, HPV DNA testing, and mobile colposcopy enables screening and treatment in remote and hard-to-reach communities where access to cervical cancer screening and treatment would otherwise be limited. Further research is warranted to assess the value and scalability of this approach in similar remote areas and its potential implementation in future programs.

Background The indicating FTA card is a dry medium used for collection of cervical samples. HPVIR is a multiplex real-time PCR test that detects 12 high-risk human papillomavirus types (hrHPV) and provides single genotype information for HPV16, − 31, − 35, − 39, − 51, − 56, and − 59 and pooled type information for HPV18/45 and HPV33/52/58. The aim of this study was to evaluate whether a strategy with cervical samples collected on the FTA card and subsequently analysed with the HPVIR test complies with the criteria of the international guidelines for a clinically validated method for cervical screening. Methods We performed a non-inferiority test comparing the clinical sensitivity and specificity of the candidate test (FTA card and HPVIR) with a clinically validated reference test (Cobas ® HPV test) based on liquid-based cytology (LBC) samples. Two clinical samples (LBC and FTA) were collected from 896 participants in population-based screening. For evaluation of the specificity we used 799 women without ≥ CIN2, and for clinical sensitivity we used 67 women with histologically confirmed ≥ CIN2. The reproducibility was studied by performing inter- and intra-laboratory tests of 558 additional clinical samples. Results The clinical sensitivity and specificity for samples collected on the FTA card and analysed using the HPVIR test were non-inferior to samples analysed with the Cobas® HPV test based on LBC samples (non-inferiority test score, p  = 1.0 × 10 − 2 and p  = 1.89 × 10 − 9 , respectively). Adequate agreement of > 87% was seen in both the intra- and inter-laboratory comparisons. Conclusions Samples collected on the indicating FTA card and analysed with HPVIR test fulfil the requirements of the international guidelines and can therefore be used in primary cervical cancer screening.

HPV test appears to be more effective in cervical cancer (CC) screening. However, the decision of its adoption as a primary screening method by substituting the established cytology lies in the evaluation of multiple criteria. Aim of this study is to evaluate the economic and clinical impact of HPV test as primary screening method for CC. A decision tree and a Markov model were developed to simulate the screening algorithm and the natural history of CC. Fourteen different screening strategies were evaluated, for women 25-65 years old. Clinical inputs were drawn from the HERMES study and cost inputs from the official price lists. In the absence of CC treatment cost data, the respective Spanish costs were used after being converted to 2017 Greek values. One-way and probabilistic sensitivity analyses were conducted. All screening strategies, that offer as primary screening method triennial HPV genotyping (simultaneous or reflex) alone or as co-testing with cytology appear to be more effective than all other strategies, with regards to both annual CC mortality, due to missed disease (-10.1), and CC incidence(-7.5) versus annual cytology (current practice). Of those, the strategy with HPV test with simultaneous 16/18 genotyping is the strategy that provides savings of 1.050 million euros annually. However, when the above strategy is offered quinquennially despite the fact that outcomes are decreased it remains more effective than current practice (-7.7 deaths and -1.3 incidence) and more savings per death averted (1.323 million) or incidence reduced (7.837 million) are realized. HPV 16/18 genotyping as a primary screening method for CC appears to be one of the most effective strategies and dominates current practice in respect to both cost and outcomes. Even when compared with all other strategies, the outcomes that it generates justify the cost that it requires, representing a good value for money alternative.

- College of American Pathologists (CAP) surveys are used to establish national benchmarks for laboratories. - To investigate human papillomavirus (HPV) genotyping testing practice patterns in laboratories in 2014. - Data were analyzed from the CAP HPV Genotyping Practices Supplemental Questionnaire distributed to 749 laboratories participating in the CAP Human Papillomavirus (High Risk) for Cytology Program. - Six hundred four of 749 laboratories (80.6%) responded to the survey. More laboratories offered HPV genotyping testing and performed in-house HPV genotyping testing as compared to previous surveys. The Roche cobas HPV test was the most commonly used genotyping method (37.0%; 160 of 433), followed by Hologic Aptima HPV16 18/45 (26.1%; 113 of 433) and Hologic Cervista HPV16/18 (14.3%; 62 of 433). Most laboratories (287 of 399; 71.9%) offered HPV genotyping for high-risk HPV cases regardless of Papanicolaou (Pap) test results and patient age; this pattern was more common in laboratories using cobas. The remaining laboratories specifically offered testing to women with a negative Pap test result at age 30 years and older (65.2%, 73 of 112) or all ages (37.5%, 42 of 112). The median reporting rates of HPV16 and/or HPV18 positivity were 20.6%, 25.7%, 21.1%, and 57.4% for women with positive high-risk HPV adjunctive negative Pap results, atypical squamous cells of undermined significance, low-grade squamous intraepithelial lesion, and high-grade squamous lesion, respectively. - Human papillomavirus genotyping testing has increased. Roche cobas and Hologic Aptima genotype methods were the most common, and laboratories using cobas usually offered genotyping regardless of Pap test result and age. The data provide a baseline and trend of HPV genotyping test practices in 2014.

BackgroundCervical cancer screening guidelines for women aged ≥30 years allow for co-testing or primary cytology testing. Our objective was to determine the test characteristics and costs associated with Cytology, HPV and Co-testing screening strategies.Main MethodsRetrospective cohort study of women undergoing cervical cancer screening with both cytology and HPV (Hybrid Capture 2) testing from 2004 to 2010 in an integrated health system. The electronic health record was used to identify women aged ≥30 years who had co-testing. Unsatisfactory or unavailable test results and incorrectly ordered tests were excluded. The main outcome was biopsy-proven cervical intraepithelial neoplasia grade 3 or higher (CIN3+).Key ResultsThe final cohort consisted of 99,549 women. Subjects were mostly white (78.4 %), married (70.7 %), never smokers (61.3 %) and with private insurance (86.1 %). Overall, 5121 (5.1 %) tested positive for HPV and 6115 (6.1 %) had cytology ≥ ASCUS; 1681 had both and underwent colposcopy and 310 (0.3 %) had CIN3+. Sensitivity for CIN3+ was 91.9 % for Primary Cytology, 99.4 % for Co-testing, and 94.8 % for Primary HPV; specificity was 97.3 % for Co-testing and Primary Cytology and 97.9 % for Primary HPV. Over a 3-year screening interval, Primary HPV detected more cases of CIN3+ and was less expensive than Primary Cytology. Co-testing detected 14 more cases of CIN3+ than Primary HPV, but required an additional 100,277 cytology tests and 566 colposcopies at an added cost of $2.38 million, or $170,096 per additional case detected.ConclusionsPrimary HPV was more effective and less expensive than Primary Cytology. Primary HPV screening appears to represent a cost-effective alternative to Co-testing.

This corrects the article DOI: 10.1038/bjc.2017.85

The aim of this survey was to examine the knowledge, attitudes, and behavior of gynecologists in terms of human papillomavirus (HPV) DNA testing as a primary screening tool for cervical cancer. A national cross-sectional web survey was carried out through multistage sampling using an overall sample of 1000 gynecologists. Gynecologists were asked to fill in a self-administered questionnaire exploring their knowledge, attitudes, and practice toward cervical cancer screening and HPV-DNA testing. A total of 582 gynecologists completed the web questionnaire. Of these, 24.5% were uncertain on the higher sensitivity of HPV-DNA compared with the Pap test, whereas 19% were uncertain on the role of the HPV-DNA test as a primary test in women younger than 30 years old and only 44.9% knew that a negative HPV-DNA test allows for an extension of the test interval to 5 years. Most gynecologists showed a definite positive attitude on the role of screening for cervical cancer prevention and were prepared to accept new technologies. The HPV-DNA test was considered highly effective by 86.9%, whereas 94% recommend/perform HPV-DNA tests in women older than 30 years of age; 25.5% performed HPV-DNA as a primary test, followed by a Pap test in those cases that were positive. Only 56.3% recommended/performed HPV-DNA tests 1 year after a positive HPV-DNA test, followed by a negative Pap test, whereas 42.9% recommended colposcopy. Although the use of the HPV-DNA test is very widespread among Italian gynecologists performing cervical cancer screening, there is lack of standardization of practices according to current guidelines.