Screening for Anal Cancer in Women with Vulvar Lesions
(Vulvar-AIN Trial)
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Female
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Dr. Danielle Vicus
No Placebo Group
Trial Summary
What is the purpose of this trial?Almost half of all women will develop an HPV infection in their lifetime. While most infections are naturally asymptomatic or cleared by the immune system, some persist and can lead to the development of cervical, vulvar, or anal lesions and eventually cancer. Screening regimens for these lesions are currently only in place for the cervix through regular Pap tests. These Pap tests usually involve an examination of the vulva -however, no screening procedures exist for anal cancer for women. Several studies have suggested that women with existing gynecological lesions are more likely to develop anal lesions and anal cancer. Here the investigators propose a multi-center study which seeks to screen for and treat anal cancer in women over the age of 40 with vulvar lesions and a stable immune system. The investigators will achieve this through performing anal Pap smears on eligible women and conducting High Resolution Anoscopy (HRA) and appropriate treatment procedures on those with abnormal anal cells. With enough evidence, there may be an indication to establish regular anal cancer screening measures in this potentially underserved population.
Hypothesis: The investigators hypothesize that at least 40% of women with vulvar cancer or VIN2/3 will have abnormal anal cytology. 35% of the population will be hrHPV DNA positive and 11% will additionally have AIN2/3. This prospective study may lay the groundwork for routine anal screening regimens in Ontario and help shift health policy to treat this population.
Do I need to stop my current medications to join the trial?
The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are taking immunosuppressant medication.
What data supports the idea that Screening for Anal Cancer in Women with Vulvar Lesions is an effective treatment?
The available research shows that high-resolution anoscopy (HRA) is considered the best method for managing anal high-grade squamous intraepithelial lesions, which can prevent anal cancer. Although there are no specific guidelines or randomized trials for its use in women with vulvar lesions, HRA is widely used for screening in high-risk groups, such as those with HIV. This suggests that it could be effective for women with vulvar lesions as well. The research also indicates that HRA is becoming more popular for screening anal dysplasia, which supports its effectiveness as a treatment.
12345What safety data exists for anal cancer screening methods?
The safety data for anal cancer screening methods, including high-resolution anoscopy (HRA) and anal Pap tests, is limited. There are no randomized controlled trials or established guidelines specifically for HRA. The understanding of these methods is largely adapted from cervical dysplasia research. HRA is considered the diagnostic standard for detecting anal dysplasia, especially in high-risk populations, but there is debate about the accuracy of these methods. The scarcity of trained providers is a noted barrier to widespread screening.
12367Is high-resolution anoscopy a promising treatment for screening anal cancer in women with vulvar lesions?
High-resolution anoscopy (HRA) is a promising treatment for screening anal cancer in women with vulvar lesions because it helps detect precancerous changes early, especially in high-risk groups. It uses a special microscope to look closely at the anal area, which can help find and manage potential cancerous changes before they develop into cancer.
12389Eligibility Criteria
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.Inclusion Criteria
I am a woman aged 40 or older.
I have had a severe precancerous condition of the vulva.
Exclusion Criteria
I have had cancer before, but it wasn't skin, cervical, or vulvar cancer.
I am a woman currently on immunosuppressant medication.
I have had a hysterectomy.
+1 more
Participant Groups
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.
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.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Odette Cancer CentreToronto, Canada
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Who Is Running the Clinical Trial?
Dr. Danielle VicusLead Sponsor
References
History of High-Resolution Anoscopy. [2020]High-resolution anoscopy (HRA) is a form of low-resolution anal microscopy currently utilized in the screening and management of anal squamous dysplasia. No randomized controlled trials, national or international guidelines exist on the use of HRA for this purpose. Much of our understanding of this entity has been adapted from the literature on cervical squamous dysplasia, including the technique of HRA itself. Epidemiologic evidence has shown that the prevalence and incidence of anal dysplasia is highest in HIV-positive populations. The history of this technique parallels the evolution of our understanding of anal dysplasia. To understand the history of the use of HRA and its place in the screening and management of anal squamous dysplasia, we discuss key advances in the understanding of human papillomavirus-related squamous dysplasia. We begin with early reports in the field establishing the link between this virus and squamous dysplasia, through the marked increase in anal cancer seen with the onset of the HIV epidemic, the identification of relevant populations at risk, the performance of the test itself, to its use today.
Patient Symptomatology in Anal Dysplasia. [2015]High-resolution anoscopy (HRA) is becoming increasingly advocated as a method of screening for anal dysplasia in high-risk patients.
A Composite Cytology-Histology Endpoint Allows a More Accurate Estimate of Anal High-Grade Squamous Intraepithelial Lesion Prevalence. [2022]There is debate about the accuracy of anal cytology and high-resolution anoscopy (HRA), in the diagnosis of anal human papillomavirus (HPV)-related squamous intraepithelial lesions (SIL). Few studies have performed both simultaneously in a large sample of high-risk individuals.
The acceptability of high resolution anoscopy examination in patients attending a tertiary referral centre. [2018]High resolution anoscopy (HRA) examination is regarded as the best method for the management of anal high grade squamous intraepithelial lesions to prevent anal squamous carcinoma. However, little is known about the acceptability of this procedure. This analysis looks at patient experience of HRA examination and ablative treatment under local anaesthetic.
Performance characteristics of anal cytology and human papillomavirus testing in patients with high-resolution anoscopy-guided biopsy of high-grade anal intraepithelial neoplasia. [2022]High-resolution anoscopy is colposcopy of the anus after applying 3 percent acetic acid. High-resolution anoscopy with biopsy was used as the standard for detecting high-grade anal neoplasia and was compared to detection of high-grade anal neoplasia by anal cytology, human papillomavirus testing, or the combination.
Anal dysplasia screening: an evidence-based analysis. [2022]This review considered the role of the anal Pap test as a screening test for anal dysplasia in patients at high risk of anal SCC. The screening process is now thought to be improved with the addition of testing for the human papillomavirus (HPV) in high-risk populations. High-resolution anoscopy (a method to view the rectal area, using an anoscope, a lighted instrument inserted into the rectum) rather than routine anoscopy-guided biopsy, is also now considered to be the diagnostic standard.
The importance of anal cancer screening and high-resolution anoscopy to gastroenterology practice. [2021]Although human papillomavirus (HPV)-related anal squamous cell cancer (ASCC) is rare, its incidence has been rising and in high-risk populations exceeds the incidence of cancers for which screening programs are implemented. Therefore, targeted screening techniques are being evaluated with high-resolution anoscopy (HRA) as the current gold standard because of its ability to detect anal intraepithelial dysplasia (AIN) and premalignant high-grade squamous intraepithelial lesions (HSILs). However, a scarcity of trained providers presents a barrier to screening.
An Update on the Current Role of High Resolution Anoscopy in Patients With Anal Dysplasia. [2019]The incidence of anal squamous cell carcinoma (ASCC) in the U.S. is increasing, particularly in immunocompromised patients. Preventative screening is used to monitor precancerous dysplasia known as anal intraepithelial neoplasia (AIN), which can progress to ASCC. High Resolution Anoscopy (HRA) is one screening procedure that uses a colposcope with acetic acid and Lugol's iodine solution to visualize the anal epithelium for AIN. HRA has offered potential in managing AIN, but as more evidence emerges it is unclear whether HRA provides definitive benefit. This narrative review updates readers on the efficacy of HRA in screening AIN, compares HRA to other techniques, compares the use of HRA in various high-risk populations, and offers practical information on the use of HRA. Keyword searches were conducted using MEDLINE, Web of Science, and Cochrane Library. Current literature is mixed regarding the utility of HRA. Further randomized controlled trials are needed to definitively assess the role of HRA.
Screening for intra-anal squamous intra-epithelial lesions in women with a history of human papillomavirus-related vulvar or perianal disease: results of a screening protocol. [2021]Women with a history of human papillomavirus (HPV)-related cervical, vaginal or vulvar high-grade squamous intra-epithelial lesions (HSILs) or cancer are at increased risk of developing anal squamous intra-epithelial lesions (SILs) or a squamous cell carcinoma of the anus (SCCA). Screening for intra-anal SILs with high-resolution anoscopy (HRA) in high-risk populations is a subject of debate. In this study we aimed to answer the following question: what is the prevalence of intra-anal (H)SIL in women with HPV-related vulvar and/or perianal disease using HRA for screening?