Anal Carcinoma

Extended HR-HPV genotyping using the BD Onclarity assay demonstrated a high prevalence of HR-HPV in this high-risk population, with multiple genotype infections commonly observed. While non-HPV16/18 genotypes predominated overall, HPV16 was more frequently associated with abnormal cytologic and high-grade histologic findings. Given the limited number of biopsy-confirmed high-grade lesions, these associations should be interpreted as descriptive and hypothesis-generating. Cytology remains central to anal cancer screening, with extended HPV genotyping serving as a complementary adjunct rather than a standalone stratification tool. Larger longitudinal studies with systematic histopathologic follow-up are needed to clarify the clinical significance of extended HPV genotyping in this population.

P=N/A, N=110, Completed, Centre Antoine Lacassagne | Recruiting --> Completed

P=N/A, N=300, Not yet recruiting, Centre Hospitalier Intercommunal Creteil | Initiation date: Mar 2026 --> Jun 2026

P2, N=33, Not yet recruiting, Jennifer Dorth | Initiation date: Mar 2026 --> Jun 2026

P=N/A, N=22, Not yet recruiting, Peking University Cancer Hospital & Institute

P=N/A, N=8, Not yet recruiting, Albert Einstein College of Medicine | Trial completion date: Apr 2030 --> Jul 2030 | Initiation date: May 2026 --> Aug 2026 | Trial primary completion date: Apr 2030 --> Jul 2030

P2, N=798, Active, not recruiting, National Cancer Institute (NCI) | Trial primary completion date: May 2027 --> May 2026

This case highlights the potential utility of tissue-based GeneXpert HPV testing as a rapid adjunctive diagnostic tool in resource-limited settings where access to histopathology is delayed. Early molecular identification of high-risk HPV may support timely clinical decision-making and facilitate linkage to care. However, its clinical impact remains constrained in the context of advanced disease at presentation, underscoring the importance of addressing structural barriers to early diagnosis and sustained HIV and cancer care in underserved regions.

This case expands the morphological spectrum of LR-HPV-associated anal neoplasia by documenting invasive carcinoma with true glandular and squamous differentiation arising in a BLT in the absence of detectable high-risk HPV. The findings support the capacity of LR-HPV-associated lesions, although exceptionally rarely, to undergo malignant transformation with divergent glandular differentiation.

P=N/A, N=254, Recruiting, Assistance Publique - Hôpitaux de Paris | Not yet recruiting --> Recruiting | Trial completion date: Feb 2028 --> Nov 2029 | Trial primary completion date: Feb 2028 --> Nov 2029

P=N/A, N=10000, Not yet recruiting, UNICANCER | Trial completion date: Jan 2032 --> Sep 2032 | Trial primary completion date: Jan 2032 --> Sep 2032

Together, these findings demonstrate the feasibility of blood-based screening and molecular risk stratification for HPV-associated cancer and precancer. Profiling blood HPV cell-free DNA detects cancer years early and distinguishes precancers needing intervention from surveillance.