Dataset Information

Triage performance of PAX1^m/JAM3^m in opportunistic cervical cancer screening of non‒16/18 human papillomavirus-positive women: a multicenter prospective study in China.

ABSTRACT:

Objectives

In this study, we aimed to validate the performance of the PAX1 and JAM3 methylation (PAX1^m/JAM3^m) test as a triage tool for detecting cervical intraepithelial neoplasia grade 3 or worse (CIN3 +) in non-16/18 high-risk human papillomavirus-positive patients (non-16/18 hrHPV +).

Methods

The triage performance of liquid-based cytology (LBC) and the PAX1^m/JAM3^m test for detecting CIN3 + were compared.

Results

In total, 1851 participants had cervical histological outcomes and were included in the analysis. The sensitivity/specificity of the LBC test results with atypical squamous cells of undetermined significance or worse (LBC ≥ ASCUS) and the PAX1^m/JAM3^m test were 90.1%/26.7% and 84.8%/88.5%, respectively. PAX1^m/JAM3^m( +) had the highest diagnostic AUC (0.866, 95% confidence interval (CI) 0.837-0.896) in the whole cohort. All cancers (n = 20) were detected by PAX1^m/JAM3^m(+). Compared with LBC ≥ ASCUS, PAX1^m/JAM3^m(+) reduced the number of patients who needed referral for colposcopy by 57.21% (74.66% vs. 17.45%). The odds ratios for detecting CIN3 + by LBC ≥ ASCUS and PAX1^m/JAM3^m(+) were 3.3 (95% CI 2.0-5.9) and 42.6 (27.1-69.6), respectively (p < 0.001). The combination of LBC ≥ ASCUS or PAX1^m/JAM3^m(+) slightly increased the diagnostic sensitivity (98.0%, 95% CI: 95.8-100%) and referral rate (77.09%) but reduced the diagnostic specificity (24.8%, 22.7-26.8%).

Conclusions

In non-16/18 hrHPV(+) women, PAX1^m/JAM3^m was superior to cytology for detecting CIN3 + . Compared with LBC ≥ ASCUS, PAX1^m/JAM3^m(+) reduced the number of significant referrals to colposcopy without compromising diagnostic sensitivity.

SUBMITTER: Chen X

PROVIDER: S-EPMC11330154 | biostudies-literature | 2024 Aug

REPOSITORIES: biostudies-literature

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Publications

Triage performance of PAX1<sup>m</sup>/JAM3<sup>m</sup> in opportunistic cervical cancer screening of non‒16/18 human papillomavirus-positive women: a multicenter prospective study in China.

Chen Xiaojing X Jin Xitong X Kong Linghua L Liou Yuligh Y Liu Pei P Dong Zhe Z Zhou Sijun S Qi Bingli B Fei Jing J Chen Xiaoyan X Xiong Guangwu G Hu Yuchong Y Liu Shikai S Zhou Jianwei J Shou Huafeng H Li Lei L

Clinical epigenetics 20240816 1

<h4>Objectives</h4>In this study, we aimed to validate the performance of the PAX1 and JAM3 methylation (PAX1<sup>m</sup>/JAM3<sup>m</sup>) test as a triage tool for detecting cervical intraepithelial neoplasia grade 3 or worse (CIN3 +) in non-16/18 high-risk human papillomavirus-positive patients (non-16/18 hrHPV +).<h4>Methods</h4>The triage performance of liquid-based cytology (LBC) and the PAX1<sup>m</sup>/JAM3<sup>m</sup> test for detecting CIN3 + were compared.<h4>Results</h4>In total, 185 ...[more]

PMID: 39152491

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Project description:ImportanceTriage tests enhance the efficiency cervical cancer screening based on human papillomavirus (HPV), but the best approach for maximizing programmatic effectiveness is still uncertain, particularly in a real-world scenario.ObjectiveTo compare the clinical performance of 6 triage strategies based on liquid-based cytology (LBC) and HPV-16 and HPV-18 genotyping individually or in combination as sequential triage tests to detect cervical intraepithelial neoplasia (CIN) grade 2 or higher among women with high-risk HPV.Design, setting, and participantsThis diagnostic study of routine cervical cancer screening was conducted at 100 primary health centers in Tlaxcala, Mexico. Women aged 30 to 64 years were recruited from August 1, 2013, to February 24, 2016, as part of the Forwarding Research for Improved Detection and Access for Cervical Cancer Screening and Triage study. Six triage scenarios for referral to colposcopy were examined: (1) LBC testing that found atypical squamous cells of undetermined significance (ASC-US) or worse, (2) positive results in HPV-16 genotyping, (3) positive results in HPV-18 genotyping, (4) positive results in HPV-16/HPV-18 genotyping, (5) positive results in HPV-16 genotyping or, if genotyping results were negative, reflex LBC testing that found ASC-US or worse, and (6) positive results in HPV-16/HPV-18 genotyping or, if genotyping results were negative, reflex LBC testing that found ASC-US or worse. Data were analyzed from October 2017 to August 2018.ExposuresLiquid-based cytological testing with simultaneous HPV-16 and HPV-18 genotyping. Women whose HPV genotyping results were positive for HPV-16 or HPV-18 or whose LBC results found ASC-US or worse and a random set of negative and normal results were referred to colposcopy with histologic analysis used for disease confirmation.Main outcomes and measuresClinical performance of each test strategy for detection of CIN grade 2 or higher. Secondary outcomes included resource utilization of each triage scenario, measured by the number of tests performed, the referral rate for colposcopy, and the numbers of colposcopies per CIN grade 2 or higher detected.ResultsA total of 36 212 women (median [interquartile range] age, 40 [35-47] years) were screened, and 4051 women (11.2%) had high-risk HPV. Of these women, 1109 (24.6%) were found to have HPV-16, HPV-18, or ASC-US or worse. Further histologic testing detected CIN grade 2 or higher in 110 of 788 women (14.0%) who underwent follow-up colposcopy. Sensitivity and specificity for 3 main triage strategies were 42.9% and 74.0% for LBC; 58.3% and 54.4% for HPV-16/HPV-18 genotyping; and 86.6% and 34.0% for HPV-16/HPV-18 genotyping with reflex LBC. The referral rate to colposcopy was 29% for HPV-16/HPV-18 with reflex LBC, which was 2-fold higher than the referral rate of 12% for LBC.Conclusions and relevanceTriage of women with high-risk HPV with HPV-16/HPV-18 genotyping with reflex LBC was significantly associated with improvement in detection of CIN grade 2 or higher compared with LBC alone. The benefit of disease prevented may outweigh the cost of increasing requirements for colposcopy services in settings with limited adherence to follow-up after a positive screening result.

Dataset Information

Triage performance of PAX1^m/JAM3^m in opportunistic cervical cancer screening of non‒16/18 human papillomavirus-positive women: a multicenter prospective study in China.

Objectives

Methods

Results

Conclusions

Publications

Triage performance of PAX1<sup>m</sup>/JAM3<sup>m</sup> in opportunistic cervical cancer screening of non‒16/18 human papillomavirus-positive women: a multicenter prospective study in China.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets

Dataset Information

Triage performance of PAX1m/JAM3m in opportunistic cervical cancer screening of non‒16/18 human papillomavirus-positive women: a multicenter prospective study in China.

Objectives

Methods

Results

Conclusions

Publications

Triage performance of PAX1<sup>m</sup>/JAM3<sup>m</sup> in opportunistic cervical cancer screening of non‒16/18 human papillomavirus-positive women: a multicenter prospective study in China.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets

Triage performance of PAX1^m/JAM3^m in opportunistic cervical cancer screening of non‒16/18 human papillomavirus-positive women: a multicenter prospective study in China.