Assessing the Utility of Plasma ctHPVDNA for Anal Cancer Screening

NCT ID: NCT06971276

Last Updated: 2025-11-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

101 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-04-03

Study Completion Date

2026-01-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Anal Dysplasia

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Anal cancer

Screening patients diagnosed with anal squamous cell carcinoma (ASCC)

No interventions assigned to this group

AIN3

Screening patients diagnosed with anal intraepithelial neoplasia 3 (AIN3)

No interventions assigned to this group

AIN2

Screening patients diagnosed with anal intraepithelial neoplasia 2 (AIN2)

No interventions assigned to this group

AIN1

Screening patients diagnosed with anal intraepithelial neoplasia 1 (AIN1)

No interventions assigned to this group

HPV Infection

Screening patients diagnosed with HPV infection (no lesion)

No interventions assigned to this group

Controls

Screening patients diagnosed negative for HPV and control patients from the general population.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Past or current anal HPV-positive population undergone anal dysplasia screening.
* Control patients from the general population.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Massachusetts Eye and Ear Infirmary

OTHER

Sponsor Role lead

Responsible Party

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Daniel L. Faden, MD

Assistant Professor, Harvard Medical School

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Daniel L. Faden, M.D.

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

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Department of Infectious Diseases, Mass General Hospital

Boston, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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18-649

Identifier Type: -

Identifier Source: org_study_id

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