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NCT06628570 · ClinicalTrials.gov registry record · NA
Screening Strategies Among High-risk Populations for Anal Cancer
A NA study of Neoplasms and HPV-Related Anal Squamous Cell Carcinoma, sponsored by Lisa Flowers.
- Recruiting
- Registry status
- NA
- Development phase
- 500
- Enrollment target
- 4
- Study locations
NCT06628570: Recruiting NA study of Neoplasms and HPV-Related Anal Squamous Cell Carcinoma, sponsored by Lisa Flowers.
NCT06628570 is a NA study of Neoplasms and HPV-Related Anal Squamous Cell Carcinoma that is actively recruiting participants, run by Lisa Flowers. The registered enrollment target is 500 participants, below the 1,618-participant average among 158 other Neoplasms trials with a reported enrollment target (69% lower). The trial reports 4 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06628570, a NA study of Neoplasms and HPV-Related Anal Squamous Cell Carcinoma, is actively recruiting participants, sponsored by Lisa Flowers.
- RECRUITING
- Registry status
- NA
- Development phase
- 500 participants
- Enrollment target
- 4
- Study locations
Study 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 populations at high risk for anal cancer and 2) characterize DNA methylation, immunologic response, and environmental factors associated with aHSIL.
Primary Outcome
Sensitivity and specificity will be calculated for each of the proposed screening markers separately and a combination of two and three markers for the detection of aHSIL at baseline. The combination of the two and three markers of primary interest includes CINtec®PLUS +hrHPV, CINtec®PLUS+anal cytology, hrHPV+anal cytology, and CINtec®PLUS+hrHPV+anal cytology. The analysis will be performed for the four high-risk groups together and stratified by the four high-risk categories.
Conditions Studied
Interventions
- DIAGNOSTIC_TEST HRA + Biopsy
- DIAGNOSTIC_TEST Anal Cytology
- DIAGNOSTIC_TEST Genotyping of anal hrHPV infection
- DIAGNOSTIC_TEST CINtec®PLUS
Study Locations (4)
Florida
- University of Miami Miller School of Medicine-Sylvester Cancer Center - Miami
- University of Miami School of Medicine at Jackson Memorial Hospital (JMH) - Miami
Georgia
- Grady Memorial Hospital - Atlanta
- The Ponce Center - Atlanta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 500 participants |
| Start Date | 2024-12-16 |
| Est. Completion | 2027-10 |
| Phase | NA |
What NCT06628570 shows while recruiting
NCT06628570 is an interventional study that assigns participants to a tested intervention. The registered 500 participants enrollment target is mid-sized for trials with a published cap, below the 1,618-participant average among 158 other Neoplasms trials with a reported enrollment target (69% lower).
The record links to 2 conditions, with Neoplasms appearing as the primary indexed condition, and to 4 interventions - of which HRA + Biopsy is the first listed.
NCT06628570 reports a single indexed study location in Florida, Georgia.
Frequently Asked Questions
What is clinical trial NCT06628570 about?
NCT06628570 is a clinical study titled "Screening Strategies Among High-risk Populations for Anal Cancer". 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 respo...
What is the current status of trial NCT06628570?
This trial is currently recruiting. It is a NA study. The enrollment target is 500 participants. The study started on 2024-12-16. Estimated completion is 2027-10.
What conditions does trial NCT06628570 study?
This clinical trial studies the following conditions: Neoplasms, HPV-Related Anal Squamous Cell Carcinoma.
What interventions are being tested in trial NCT06628570?
The interventions under investigation include: HRA + Biopsy (DIAGNOSTIC_TEST), Anal Cytology (DIAGNOSTIC_TEST), Genotyping of anal hrHPV infection (DIAGNOSTIC_TEST), CINtec®PLUS (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT06628570?
This trial is sponsored by Lisa Flowers, which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06628570 being conducted?
This trial has 4 study locations across Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06628570's enrollment target sits among peer trials
500 23rd of 158 higher than 135 of 158 other Neoplasms trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Neoplasms trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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