Trials Sponsors Conditions Drugs Pricing

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.

Sponsors & Collaborators

Massachusetts Eye and Ear Infirmary
Otherlead

Study Sites (1)

Department of Infectious Diseases, Mass General Hospital

Boston, Massachusetts, 02114, United States

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

Enrollment

104 participants (actual enrollment reported by the registry).

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

Actual (reported)

Assessing the Utility of Plasma ctHPVDNA for Anal Cancer Screening

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Study Arms (6)

Anal cancer

AIN3

AIN2

AIN1

HPV Infection

Controls

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Biospecimen

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Study Arms (6)

Anal cancer

AIN3

AIN2

AIN1

HPV Infection

Controls

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Biospecimen

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Data Sharing

Source record

Locations