← Back to Search

Screening for Anal Cancer in Women with Vulvar Lesions (Vulvar-AIN Trial)

N/A

Recruiting

Led By Danielle Vicus, MD

Research Sponsored by Dr. Danielle Vicus

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new way to screen for and treat anal cancer in women with vulvar lesions.

Who is the study for?

This trial is for women aged 40 or older who have been previously diagnosed with high-grade vulvar dysplasia (VIN 2/3) or vulvar cancer. It aims to screen these individuals for anal cancer, as they may be at higher risk due to their existing conditions.

What is being tested?

The study is testing the effectiveness of screening for anal cancer using anal Pap smears followed by High-resolution Anoscopy (HRA) in detecting abnormal cells. The goal is to potentially establish regular screening procedures for women with a history of gynecological lesions.

What are the potential side effects?

As this trial involves screening tests like Pap smears and HRA rather than medication, side effects are minimal but may include discomfort during the procedure and potential anxiety awaiting results.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Group I: Screening anal Pap Smear - PositiveExperimental Treatment1 Intervention

All patients will receive an anal Pap test. Any patient with abnormal cytology on their Pap test will be referred to HRA clinic for management. This includes potential biopsy and treatment.

Group II: Screening anal Pap Smear - Negative (75%)Experimental Treatment1 Intervention

All patients will receive an anal Pap test. 75% of patients with a negative anal Pap will complete study with no further intervention.

Group III: Screening anal Pap Smear - Negative (25%)Experimental Treatment1 Intervention

All patients will receive an anal Pap test. Remaining 25% of patients will proceed to high-resolution anoscopy (HRA) clinic to assess the negative predictive rate of HRA.

Do I qualify?Apply below to find out