At the 2025 Society of Gynecologic Oncology (SGO) Annual Meeting on Women’s Cancer, Kersten Rothnie, MBBS, a gynecologic oncology fellow at Northwell Health in New York City, shared study findings on an investigational tool on behalf of her colleagues.1 These results suggested the presence of circulating tumor tissue–modified viral human papillomavirus (HPV) DNA may be predictive of the presence of advanced-stage disease in patients with newly diagnosed cervical cancer.
“Circulating tumor HPV DNA can serve as a universal tumor marker for these HPV-driven cancers and will meet this unmet need (for new methods of detection),” Dr. Rothnie said in an SGO press release. “This has the potential to be a practice-changer.”
Study Details
The multisite prospective study included patients with biopsy-proven high-grade cervical dysplasia (cervical intraepithelial neoplasia grade [CIN] 2/3) as well as patients diagnosed with invasive cervical carcinoma, with positive HPV 16/18 subtypes included. The median patient age was 50 years. Approximately one-third of patients were White, and another third were Hispanic.
NavDx digital droplet chain reaction testing was used to detect circulating fragments of tumor tissue-modified viral–HPV DNA released by the HPV-associated cancer cells in the serum. Samples were collected before, during, and after treatment. A history of other known HPV-related cancers was an exclusion criterion.
At the time of analysis, results were available for 34 patients (12 with CIN2/3 and 22 with cervical carcinoma). Of the patients with cervical carcinoma, 15 (68.2%) presented with primary disease, and 7 (31.8%) presented with recurrence. In that same group, eight of those with primary cervical carcinoma had stage I or II disease, and seven had stage III or IV disease.
According to Dr. Rothnie, the sensitivity and specificity for tumor tissue-modified viral–HPV DNA testing for the detection of cervical carcinoma were 63.6% (95% confidence interval [CI] = 40.6%–82.8%) and 100% (95% CI = 73.5%–100%), respectively. The sensitivity was 37.5% (95% CI = 8.5%–75.5%) for patients with stage I or II cervical carcinoma and 100% (95% CI = 59.0%–100%) for patients with stage III or IV cervical carcinoma.
All patients with cervical carcinoma who had positive tumor tissue-modified viral–HPV DNA at baseline had a decrease in scores after the start of treatment. Disease progression or persistence was diagnosed in five patients, who had corresponding increased scores.
“As our pilot study continues, additional patients are enrolling, and an expanded panel including the 16 most prevalent high-risk HPV subtypes has been developed,” Dr. Rothnie said in an SGO press release. “Analysis of specimens is under way. The availability of these additional subtypes will allow tumor tissue-modified viral–HPV DNA to truly serve as a universal biomarker for these HPV-driven cancers.”
Although the potential biomarker has shown promise, Dr. Rothnie cautions that the results are preliminary, and there is still more work to be done. “While our study has demonstrated the monitoring of tumor tissue-modified viral–HPV DNA dynamically corresponds with treatment response for cervical cancer, as well as persistence or progression of the disease, we are unable to comment on tumor tissue-modified viral–HPV DNA as a prognostic biomarker until there is sufficient maturation of survival data,” she stated. “From these promising preliminary results, the use of tumor tissue-modified viral–HPV DNA presents a potential noninvasive tool for the detection and monitoring of cervical cancer.”
DISCLOSURE: Dr. Rothnie reported no conflicts of interest.
REFERENCE
1. Rothnie K, et al: 2025 SGO Annual Meeting on Women’s Cancer. Abstract 38.
