NCT06971276

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
104

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 3, 2024

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

May 5, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 14, 2025

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

April 28, 2026

Status Verified

April 1, 2026

Enrollment Period

1.7 years

First QC Date

May 5, 2025

Last Update Submit

April 27, 2026

Conditions

Anal Dysplasia

Keywords

HPVLiquid biopsyAnal cancerAnal intraepithelial neoplasiaEarly cancer detectionHPV-DeepSeekNGS

Outcome Measures

Primary Outcomes (1)

  • Cancer Developmental Stage

    Anal dysplasia screening results based on tissue biopsy collected at time of the visit or clinical diagnosis when biopsy is not available.

    Periprocedural

Study Arms (6)

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Infectious Diseases, Mass General Hospital

Boston, Massachusetts, 02114, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood, plasma, and tumor tissue

MeSH Terms

Conditions

Anus Neoplasms

Condition Hierarchy (Ancestors)

Rectal NeoplasmsColorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesIntestinal DiseasesAnus DiseasesRectal Diseases

Study Officials

  • Daniel L. Faden, M.D.

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor, Harvard Medical School

Study Record Dates

First Submitted

May 5, 2025

First Posted

May 14, 2025

Study Start

April 3, 2024

Primary Completion

December 31, 2025

Study Completion

December 31, 2025

Last Updated

April 28, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)