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Assessing the Utility of Plasma ctHPVDNA for Anal Cancer Screening

Assessing the Utility of Plasma ctHPVDNA for Anal Cancer Screening

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06971276
Acronym
SCAN-LITE
Enrollment
104
Registered
2025-05-14
Start date
2024-04-03
Completion date
2025-12-31
Last updated
2026-04-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anal Dysplasia

Keywords

HPV, Liquid biopsy, Anal cancer, Anal intraepithelial neoplasia, Early cancer detection, HPV-DeepSeek, NGS

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.

Interventions

None listed

Sponsors

Massachusetts Eye and Ear Infirmary
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Cancer Developmental StagePeriproceduralAnal dysplasia screening results based on tissue biopsy collected at time of the visit or clinical diagnosis when biopsy is not available.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORDaniel L. Faden, M.D.

Massachusetts General Hospital

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 29, 2026