Clinical trial NCT06628570: Screening Strategies for People With a High Risk of Anal Cancer
Official title: Screening Strategies and Social Determinants of Health Among People With High Risk of Anal Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Neoplasms
HPV-Related Anal Squamous Cell Carcinoma
Keywords: Cancer
HIV
Screening
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2024-10-08
Enrollment: 500
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: 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 minorities with a high risk of anal cancer and 2) characterize DNA methylation, immunologic response, and social determinants associated with aHSIL.

Detailed 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 living with HIV. The study is important because the incidence of anal cancer is particularly high among certain groups; health disparity further contributes to this high risk among minorities. Findings will provide much-needed evidence for anal cancer screening strategies to reduce health disparities, improve screening outcomes, and decrease the incidence of anal cancer among high-risk minorities. The study population includes Black or Latinx, males - men having sex with men (MSM) only - 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.

Eligibility criteria: Inclusion Criteria:

* 30 years of age and older
* Identifies as Black or Latinx,
* Males (MSM only) and females with a known history of high-grade lower genital tract neoplasia (LGTN), Zubrod Performance Status of 0-2;
* Women with Human Papillomavirus (HPV) related cervical, vaginal, or vulvar high-grade precancer or cancer

Exclusion Criteria:

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

Primary outcomes:
measure: Specificity and Sensitivity of screening markers
timeFrame: Baseline
Secondary outcomes:
measure: DNA methylation markers
timeFrame: Baseline, 1 year, 2 years
measure: Anal immune modulations
timeFrame: Baseline, 1 year, 2 years
measure: aHSIL prevalence
timeFrame: Baseline
measure: aHSIL clearance
timeFrame: 1 year, 2 years
measure: Inflammatory Markers (Il-1RA, IL1β, IL6, IL6sr, TNF-α, and IL-10)
timeFrame: Baseline, 1 year, 2 years
measure: Inflammatory Markers (sTNFR2 and interferon (IFN)-γ)
timeFrame: Baseline, 1 year, 2 years
measure: Inflammatory Marker (CRP)
timeFrame: Baseline, 1 year, 2 years
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami Miller School of Medicine-Sylvester Cancer Center
state: Florida
city: Miami
country: United States
facility: University of Miami School of Medicine at Jackson Memorial Hospital (JMH)
state: Florida
city: Atlanta
country: United States
facility: Grady Memorial Hospital
state: Georgia
city: Atlanta
country: United States
facility: The Ponce Center
state: Georgia
Study officials:
affiliation: Emory University
name: Lisa Flowers, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Emory University
name: Canhua Xiao, PhD, RN
role: PRINCIPAL_INVESTIGATOR
References: