Assessing the Utility of Plasma ctHPVDNA for Anal Cancer Screening (SCAN-LITE)

April 27, 2026 updated by: Daniel L. Faden, MD, Massachusetts Eye and Ear Infirmary
The study is to test a liquid biopsy assay for screening and classifying anal dysplasia from blood.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

104

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Department of Infectious Diseases, Mass General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Patients undergone screening for anal dysplasia and control patients from the general population.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Anal cancer
Screening patients diagnosed with anal squamous cell carcinoma (ASCC)
AIN3
Screening patients diagnosed with anal intraepithelial neoplasia 3 (AIN3)
AIN2
Screening patients diagnosed with anal intraepithelial neoplasia 2 (AIN2)
AIN1
Screening patients diagnosed with anal intraepithelial neoplasia 1 (AIN1)
HPV Infection
Screening patients diagnosed with HPV infection (no lesion)
Controls
Screening patients diagnosed negative for HPV and control patients from the general population.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cancer Developmental Stage
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.
Periprocedural

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Massachusetts Eye and Ear Infirmary

Investigators

  • Principal Investigator: Daniel L. Faden, M.D., Massachusetts General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 3, 2024

Primary Completion (Actual)

December 31, 2025

Study Completion (Actual)

December 31, 2025

Study Registration Dates

First Submitted

May 5, 2025

First Submitted That Met QC Criteria

May 12, 2025

First Posted (Actual)

May 14, 2025

Study Record Updates

Last Update Posted (Actual)

April 28, 2026

Last Update Submitted That Met QC Criteria

April 27, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 18-469

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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