Department of Infectious Diseases, Mass General Hospital
Boston, Massachusetts, 02114, United States
NCT Number: NCT06971276
The study is to test a liquid biopsy assay for screening and classifying anal dysplasia from blood.
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Notify Me18 year and older
All sexes
Observational
Boston, Massachusetts, 02114, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: Periprocedural
Anal dysplasia screening results based on tissue biopsy collected at time of the visit or clinical diagnosis when biopsy is not available.
Massachusetts Eye and Ear Infirmary
Other
Acronym: SCAN-LITE
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