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Screening anal Pap Smear - Negative (75%) for Vulvar Cancer (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 6 months to 1 year
Awards & highlights
Vulvar-AIN Trial 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.Check my eligibility
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.See study design
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.
Vulvar-AIN Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months to 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months to 1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Prevalence of abnormal anal cytology and hrHPV DNA in women with VIN 2/3 or vulvar cancer
Secondary outcome measures
Assess t he correlation between abnormal anal cytology, hrHPV DNA, and AIN
Prevalence of AIN in women with VIN 2/3 or vulvar cancer
Vulvar-AIN 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.
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Who is running the clinical trial?
Dr. Danielle VicusLead Sponsor
Danielle Vicus, MDPrincipal InvestigatorOdette Cancer Centre
1 Previous Clinical Trials
200 Total Patients Enrolled
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any available slots for enrollment in this research endeavor?
"Per the information available on clinicaltrials.gov, this research study is currently soliciting volunteers. The trial was first advertised on February 1st 2021 and has undergone recent updates as of May 11th 2021."
Answered by AI
What is the maximum capacity of participants for this clinical experiment?
"Affirmative, the information on clinicaltrials.gov demonstrates that this trial is currently recruiting participants. The original posting date was February 1st 2021 and it has been amended most recently on May 11th 2021. 110 individuals need to be enlisted from a single medical site."
Answered by AI
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