Xun Tian

Testing menstrual blood for human papillomavirus during cervical cancer screening in China: cross sectional population based study

Abstract Objective To compare the diagnostic accuracy of minipad collected menstrual blood versus clinician collected cervical samples to test for human papillomavirus (HPV) in the detection of cervical intraepithelial neoplasia grade 2/3 or worse (CIN2+/CIN3+). Design Cross sectional population based study. Setting Four urban and three rural communities in Hubei Province, China. Participants 3068 women aged 20-54 years with regular menstrual cycles, enrolled between September 2021 and January 2025. Interventions HPV testing using minipad collected menstrual blood, clinician collected cervical samples, and ThinPrep cytology. Women who tested HPV positive by either collection method or by cytology (atypical squamous cells of undetermined significance or worse) were referred for colposcopy directed biopsy sampling. Main outcome measure Diagnostic accuracy for detecting CIN2+ and CIN3+. Results Among 3068 participants, minipad based HPV testing showed a sensitivity of 94.7% (95% confidence interval 80.9% to 99.1%) for CIN2+ detection, comparable to clinician based HPV testing (92.1%, 77.5% to 97.9%; P=1.00). Although minipad HPV testing showed a lower specificity than clinician HPV testing (89.1%, 88.0% to 90.2% v 90.0%, 88.9% to 91.1%; P=0.001), the negative predictive value matched that of clinician HPV testing (99.9%, 99.7% to 100.0% v 99.9%, 99.7% to 100.0%; P=1.00). Both collection methods had a similar positive predictive value (9.9%, 7.1% to 13.5% v 10.4%, 7.4% to 14.3%; P=0.82) and screening efficiency (10.1 v 9.6 referrals per CIN2+ detected; P=0.82). Conclusions Minipad collected menstrual blood showed comparable diagnostic accuracy to clinician collected cervical samples for HPV testing for detecting CIN2+ and CIN3+. Trial registration ClinicalTrials.gov NCT06082765 .

A Fifteen‐Gene Classifier to Predict Neoadjuvant Chemotherapy Responses in Patients with Stage IB to IIB Squamous Cervical Cancer

AbstractNeoadjuvant chemotherapy (NACT) remains an attractive alternative for controlling locally advanced cervical cancer. However, approximately 15–34% of women do not respond to induction therapy. To develop a risk stratification tool, 56 patients with stage IB‐IIB cervical cancer are included in 2 research centers from the discovery cohort. Patient‐specific somatic mutations led to NACT non‐responsiveness are identified by whole‐exome sequencing. Next, CRISPR/Cas9‐based library screenings are performed based on these genes to confirm their biological contribution to drug resistance. A 15‐gene classifier is developed by generalized linear regression analysis combined with the logistic regression model. In an independent validation cohort of 102 patients, the classifier showed good predictive ability with an area under the curve of 0.80 (95% confidence interval (CI), 0.69–0.91). Furthermore, the 15‐gene classifier is significantly associated with patient responsiveness to NACT in both univariate (odds ratio, 10.8; 95% CI, 3.55–32.86; p = 2.8 × 10−5) and multivariate analysis (odds ratio, 17.34; 95% CI, 4.04–74.40; p = 1.23 × 10−4) in the validation set. In conclusion, the 15‐gene classifier can accurately predict the clinical response to NACT before treatment, representing a promising approach for guiding the selection of appropriate treatment strategies for locally advanced cervical cancer.

Cervical Cancer Screening with NGS-HPV Technology Based on Menstrual Blood

Our study is a population-based, cross-sectional study. This study is conducted to recruit cervical cancer screening participants to evaluate the application value of using high-throughput sequencing technology to detect HPV in menstrual blood for cervical cancer screening. Our study is designed as a two-phase study : Phase I : This phase, which will be preparing to recruit 5,000 participants, evaluates the accuracy of menstrual blood (MB) self-sampling for detecting cervical intraepithelial neoplasia grade two or worse (CIN2+) in the general population, with a secondary objective to evaluate the Minipad as a special device to collect MB. Phase II : This phase, which will continue to recruit toward the 10,000-participant target, will evaluate additional molecular markers (specifically DNA methylation) to optimize alternative triage methods for HPV-positive women in menstrual blood (MB) self-sampling. This phase aims to further reduce unnecessary colposcopies while maintaining high sensitivity for CIN2+ detection.