Screening Strategies Among High-risk Populations for Anal Cancer

Lisa Flowers

Status: Enrolling

Conditions: HPV-Related Anal Squamous Cell Carcinoma; Neoplasms

Treatments: Diagnostic Test: Anal Cytology; Diagnostic Test: Genotyping of anal hrHPV infection; Diagnostic Test: CINtec®PLUS; Diagnostic Test: HRA + Biopsy

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06628570

STUDY00006091

R01CA285198 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

The goal of the proposed research is to 1) examine the performance of emerging screening methods for anal high-grade squamous intraepithelial lesion (aHSIL), a precancerous condition of anal cancer, among populations at high risk for anal cancer and 2) characterize DNA methylation, immunologic response, and environmental factors associated with aHSIL.

Full description

Anal cancer, caused by persistent infection with high-risk human papillomavirus (hrHPV), is typically preceded by anal high-grade squamous intraepithelial lesions (aHSIL). The incidence and mortality of advanced anal cancer has been increasing in the U.S., with the greatest burden of disease and mortality in individuals with chronic impairment of the immune system. The study is important because the incidence of anal cancer is particularly high among certain groups. Findings will provide much-needed evidence for anal cancer screening strategies to reduce incidence of anal cancer and improve health outcomes. The study population includes individuals with chronic impairment of the immune system and females with a known history of high-grade lower genital tract neoplasia.

The study procedures include filling out self-reported questionnaires and collecting biosamples for study-related assays. HRA is part of the standard clinic procedure for this group of participants. Collected biosamples will be banked for future research use. In-person or remote signed consent may occur for the study.

Enrollment: 500 estimated patients

Sex: All

Ages: 30 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 30-80 years of age
• Individuals with chronic impaired immune status
• History of high-grade lower genital tract neoplasia (LGTN), Zubrod Performance Status of 0-2;

Exclusion criteria

• Patients treated for aHSIL less than 6 months before screening,
• History of anal cancer and pregnant women.

Trial design

Primary purpose: Screening

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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500 participants in 4 patient groups

Men with impaired immune status

Other group

Description:

At each study visit, participants will receive a digital anorectal examination followed by HRA, with directed biopsies of suspicious lesions. An HRA-certified physician will collect anal swabs and HRA-directed biopsies for histological confirmation of disease and biomarker assays.

Treatment:

Diagnostic Test: HRA + Biopsy

Diagnostic Test: CINtec®PLUS

Diagnostic Test: Genotyping of anal hrHPV infection

Diagnostic Test: Anal Cytology

Men without impaired immune status

Other group

Description:

At each study visit, participants will receive a digital anorectal examination followed by HRA, with directed biopsies of suspicious lesions. An HRA-certified physician will collect anal swabs and HRA-directed biopsies for histological confirmation of disease and biomarker assays.

Treatment:

Diagnostic Test: HRA + Biopsy

Diagnostic Test: CINtec®PLUS

Diagnostic Test: Genotyping of anal hrHPV infection

Diagnostic Test: Anal Cytology

Women with impaired immune status and high grade LGTN

Other group

Description:

At each study visit, participants will receive a digital anorectal examination followed by HRA, with directed biopsies of suspicious lesions. An HRA-certified physician will collect anal swabs and HRA-directed biopsies for histological confirmation of disease and biomarker assays.

Treatment:

Diagnostic Test: HRA + Biopsy

Diagnostic Test: CINtec®PLUS

Diagnostic Test: Genotyping of anal hrHPV infection

Diagnostic Test: Anal Cytology

Women without impaired immune status with high grade LGTN

Other group

Description:

At each study visit, participants will receive a digital anorectal examination followed by HRA, with directed biopsies of suspicious lesions. An HRA-certified physician will collect anal swabs and HRA-directed biopsies for histological confirmation of disease and biomarker assays.

Treatment:

Diagnostic Test: HRA + Biopsy

Diagnostic Test: CINtec®PLUS

Diagnostic Test: Genotyping of anal hrHPV infection

Diagnostic Test: Anal Cytology