Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06628570
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-03
Brief Title:
Screening Strategies for People with a High Risk of Anal Cancer
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Screening Strategies and Social Determinants of Health Among People with High Risk of Anal Cancer
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 US 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None