Expanded subtype testing for circulating tumor HPV DNA reliably detects the presence of advanced-stage cervical cancer

IF 4.1 2区医学 Q1 OBSTETRICS & GYNECOLOGY

Gynecologic oncology Pub Date : 2026-04-01 Epub Date: 2026-04-17 DOI:10.1016/j.ygyno.2026.02.013

Kersten Rothnie , Emilie Tristano , Mariuxi Diaz-Rodriguez , Olga Filippova , Gizelka David-West , Joan Tymon-Rosario , Jill Whyte , Marina Frimer , Tung Ming Leung , Fidel Valea , Jeannine Villella , Elena Pereira

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引用次数: 0

Abstract

Objectives

To demonstrate the detection of circulating human papillomavirus (HPV) DNA fragments can serve as a biomarker for presence of tumor and provide a universal, non-invasive tool for monitoring treatment response in HPV-related cervical cancers (CC).

Methods

A multi-site prospective study of HPV-positive high-grade cervical dysplasia (CIN2/3) and CC was conducted. Serum samples were collected pre-, during, and post-treatment. NavDx® (Naveris,Inc) digital droplet polymerase chain reaction testing was used to detect tumor tissue modified viral (TTMV)-HPV DNA. The expanded panel included 14 HPV subtypes. Sensitivity and specificity were calculated for the pre-treatment Score only. Scores were quantified for on-treatment timepoints and trends were compared against treatment response.

Results

80 patients were included in the analysis: 46 (57.5%) CC, 26 (32.5%) CIN2/3, 8 (10.0%) benign. TTMV-HPV DNA was undetectable in all CIN 2/3 and benign cases. For CC, 38 (82.6%) had primary disease and 8 (17.4%) recurrent. For primary CC, 28 (73.7%) had stage I/II and 10 (26.3%) stage III/IV. Specificity for TTMV-HPV DNA for CC detection was 100% (95% CI: 89.7%–100.0%) for all stages. Sensitivity was 39.2% (95% CI: 21.5–59.4%) for stage I/II, 90% (95% CI: 55.5–99.7%) for stage III/IV, and 62.5% (95% CI: 24.4–91.48%) at recurrence. Disease progression/persistence occurred in 7 patients with corresponding increased Scores.

Conclusions

TTMV-HPV DNA is a sensitive and specific biomarker for advanced CC, with Scores dynamically corresponding to treatment response, and has the potential to serve an unmet need as a universal biomarker for patients with HPV-related CC.

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循环肿瘤HPV DNA扩展亚型检测可靠地检测晚期宫颈癌的存在

目的证明循环人乳头瘤病毒（HPV） DNA片段的检测可以作为肿瘤存在的生物标志物，并为HPV相关宫颈癌（CC）的治疗反应监测提供一种通用的、无创的工具。方法对hpv阳性的高级别宫颈发育不良（CIN2/3）和CC进行多部位前瞻性研究。分别在治疗前、治疗中和治疗后采集血清样本。采用NavDx®（naaveris,Inc）数字液滴聚合酶链反应检测肿瘤组织修饰病毒(TTMV)-HPV DNA。扩大的小组包括14种HPV亚型。仅计算治疗前评分的敏感性和特异性。对治疗时间点的评分进行量化，并将趋势与治疗反应进行比较。结果80例患者纳入分析：CC 46例（57.5%），CIN2/3 26例（32.5%），良性8例（10.0%）。所有CIN 2/3及良性病例均未检出TTMV-HPV DNA。对于CC， 38例（82.6%）为原发疾病，8例（17.4%）为复发。对于原发性CC， 28例（73.7%）为I/II期，10例（26.3%）为III/IV期。TTMV-HPV DNA在所有分期中检测CC的特异性为100% （95% CI: 89.7%-100.0%）。I/II期敏感性为39.2% (95% CI: 21.5-59.4%)， III/IV期敏感性为90% (95% CI: 55.5-99.7%)，复发敏感性为62.5% （95% CI: 24.4-91.48%）。7例患者出现疾病进展/持续，相应的评分增加。结论sttmv - hpv DNA是晚期CC的敏感特异性生物标志物，其评分动态对应于治疗反应，有潜力作为hpv相关CC患者的通用生物标志物，满足未满足的需求。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Gynecologic oncology 医学-妇产科学

CiteScore

8.60

自引率

6.40%

发文量

1062

审稿时长

37 days

期刊介绍： Gynecologic Oncology, an international journal, is devoted to the publication of clinical and investigative articles that concern tumors of the female reproductive tract. Investigations relating to the etiology, diagnosis, and treatment of female cancers, as well as research from any of the disciplines related to this field of interest, are published. Research Areas Include: • Cell and molecular biology • Chemotherapy • Cytology • Endocrinology • Epidemiology • Genetics • Gynecologic surgery • Immunology • Pathology • Radiotherapy