Screening Strategies for Anal Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to test new screening methods for identifying and understanding anal pre-cancer conditions. It focuses on individuals at higher risk of developing anal cancer, particularly those with weakened immune systems or a history of certain genital conditions. Participants will undergo exams to detect suspicious areas and collect samples for further testing. Those with a long-term weakened immune system or a history of high-grade genital tract issues might be suitable candidates for this trial. As an unphased trial, this study offers participants the opportunity to contribute to pioneering research that could enhance early detection methods for anal cancer.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
Why are researchers excited about this trial?
Researchers are excited about this trial because it's exploring new screening strategies for anal cancer in high-risk groups. Unlike current methods, this approach involves digital anorectal exams combined with High-Resolution Anoscopy (HRA) to directly target suspicious lesions. The trial's unique angle is its focus on different immune statuses and the inclusion of biomarker assays, which could lead to more personalized and effective screening protocols. This could potentially improve early detection and treatment outcomes for those at risk.
Who Is on the Research Team?
Lisa Flowers, MD, MPH
Principal Investigator
Emory University
Canhua Xiao, PhD, RN
Principal Investigator
Emory University
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Baseline Assessment
Participants undergo baseline assessments including digital anorectal examination, HRA, and collection of biosamples for histological confirmation and biomarker assays
Follow-up
Participants are monitored for safety and effectiveness, with follow-up visits at 1 year and 2 years to assess aHSIL clearance and inflammatory markers
What Are the Treatments Tested in This Trial?
Interventions
- Anal Cytology
- CINtec®PLUS
- Genotyping of anal hrHPV infection
- HRA + Biopsy
How Is the Trial Designed?
4
Treatment groups
Experimental Treatment
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.
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.
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.
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Lisa Flowers
Lead Sponsor
National Cancer Institute (NCI)
Collaborator
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