Assessing the Utility of Plasma ctHPVDNA for Anal Cancer Screening

Recruiting

• Conditions: Anal Dysplasia

• Registration Number: NCT06971276
• Lead Sponsor: Massachusetts Eye and Ear Infirmary

Brief Summary

The study is to test a liquid biopsy assay for screening and classifying anal dysplasia from blood.

Detailed Description

Anal squamous cell carcinoma, despite being considered as a rare cancer, has seen a steady rise in incidence over the past three decades. Recent evidence from the Anal Cancer-HSIL Outcomes Research (ANCHOR) study demonstrated benefits of treating anal high-grade squamous intraepithelial lesion (HSIL), highlighting the importance of screening anal cancers and high-grade precancers. Current anal cancer screening starts with HPV testing and/or cytology for primary screening, followed by high-resolution anoscopy (HRA) with biopsy for confirmatory diagnosis. However, the poor specificity of HPV testing and the extremely limited capacity of HRA urges the development of new screening approaches for identifying anal high-grade precancers and cancers. Blood circulating tumor HPV DNA (ctHPVDNA) is an emerging non-invasive biomarker for screening and treatment monitoring of HPV-associated cancers, but its significance in anal cases remains underexplored. Here the investigators use an ultrasensitive HPV whole genome sequencing assay to test the hypothesis that anal precancers are detectable in the blood.

Study Timeline

• Study Start: 2024-04-03
• Status Verified: 2025-05
• Study First Submitted: 2025-05-05
• Study First Submitted QC: 2025-05-12
• Last Update Submitted: 2025-05-12
• Study First Posted: 2025-05-14
• Last Update Posted: 2025-05-14
• Primary Completion: 2025-07
• Study Completion: 2025-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 101

Inclusion Criteria

• Past or current anal HPV-positive population undergone anal dysplasia screening.
• Control patients from the general population.

Exclusion Criteria

• Not meeting inclusion criteria.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Cancer Developmental Stage	Periprocedural	Anal dysplasia screening results based on tissue biopsy collected at time of the visit or clinical diagnosis when biopsy is not available.

Trial Locations

Locations (1)

Department of Infectious Diseases, Mass General Hospital; 🇺🇸 Boston, Massachusetts, United States