Screening Tests for Cervical and Anal Cancer in HIV Patients
(CAMPO-101 Trial)
Recruiting in Palo Alto (17 mi)
+5 other locations
Overseen ByJoel Palefsky, MD
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of California, San Francisco
Must be taking: Antiretrovirals
Disqualifiers: Hysterectomy, Cancer history, Recent lesion treatment, others
No Placebo Group
Trial Summary
What is the purpose of this trial?This trial uses quick tests to find abnormal tissue changes in the cervix or anus in men and women with HIV. These patients are at higher risk for HPV-related cancers. The tests help detect early signs of potential cancer so that further checks and treatments can be done if needed.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, it does require documentation of antiretroviral therapy (ART) for HIV, so you may need to continue those medications.
What data supports the effectiveness of the treatment for screening cervical and anal cancer in HIV patients?
Research shows that using high-resolution anoscopy and biopsies can help accurately diagnose anal dysplasia in HIV patients. Additionally, molecular markers and hybrid capture techniques have been effective in screening for cervical cancer in women with HIV, offering high sensitivity in detecting precursor lesions.
12345Is it safe to undergo colposcopy and high-resolution anoscopy for cancer screening?
Colposcopy and high-resolution anoscopy are generally safe procedures used to screen for cervical and anal cancer, respectively. While they may cause some discomfort, they are important for identifying precancerous lesions and preventing cancer progression.
678910How does this treatment for cervical and anal cancer screening in HIV patients differ from other treatments?
This treatment is unique because it uses new biomarkers, originally developed for cervical cancer screening, to provide a targeted and easy-to-perform screening for anal dysplasia in HIV patients, which is not yet standardized. Unlike high-resolution imaging, which is not suitable for mass screening, these biomarkers offer a more accessible approach.
511121314Eligibility Criteria
This trial is for adults over 21 with HIV who have not had a hysterectomy, are not pregnant or recently post-partum, and haven't been treated for related lesions in the last 18 months. They must understand the study and agree to participate, have an ECOG performance status of <=1 (or Karnofsky >=70%), documented HIV infection, and be on antiretroviral therapy.Inclusion Criteria
Documentation of HIV-1 infection by means of any one of the following: Documentation of HIV diagnosis in the medical record by a licensed health care provider, Documentation of receipt of antiretroviral therapy (ART) by a licensed health care provider, HIV-1 ribonucleic acid (RNA) detection by a licensed HIV-1 RNA assay demonstrating > 1000 RNA copies/mL, Any locally licensed HIV screening antibody and/or HIV antibody/antigen combination assay confirmed by a second licensed HIV assay such as a HIV-1 Western blot confirmation or HIV rapid multispot antibody differentiation assay, Age 21 years or older, Eastern Cooperative Oncology Group (ECOG) performance status =< 1 (Karnofsky score >= 70%), Ability to understand and the willingness to sign a written informed consent document
Exclusion Criteria
Participants who have undergone hysterectomy, History of anal cancer, penile, vulvar, vaginal, or cervical cancer, Potential participants who received prior treatment of anal, cervical, penile, vaginal, or vulvar lesions within 18 months of study enrollment, Inability in the opinion of the study investigator of the participant to comply with study requirements, Participants who are pregnant (a urine pregnancy test will be provided to participants aged 60 years or less) or within 2 months being post-partum
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Initial Assessment and Testing
Participants undergo collection of cervical images, cervical and anal swabs for real-time testing of high-risk HPV. Positive results lead to further diagnostic procedures such as colposcopy or high-resolution anoscopy.
1 month
2 visits (in-person)
Diagnosis and Treatment
Participants may receive a diagnosis and treatment based on test results. Those diagnosed with HSIL may undergo standard of care treatment or enroll in additional studies.
1 month
1 visit (in-person)
Follow-up
Participants are monitored for safety and effectiveness after treatment, with potential for additional studies.
Up to 3 years
Participant Groups
The trial tests various screening methods like biopsies and imaging techniques to detect high-grade squamous intraepithelial lesions (HSIL) that could lead to cervical or anal cancer in people with HIV. It aims to identify which screenings work best for early detection.
1Treatment groups
Experimental Treatment
Group I: Imaging, biospecimen collection, anoscopy and/or colposcopyExperimental Treatment6 Interventions
Patients undergo collection of cervical images (if applicable), 3 cervical anal swabs (if applicable) and 3 anal swabs for real-time testing of HPV or hrHPV over 90 minutes. Patients with a positive HPV or hrHPV test on undergo biopsies of visible lesions. Patients with a negative hrHPV test on their cervical swab may undergo a colposcopy. Patients with a positive hrHPV test on their anal swab undergo high-resolution anoscopy at a later visit within 1 month. Patients with a negative hrHPV on their anal swabs may undergo a high-resolution anoscopy and biopsies of visible lesions, and those with a positive anal cytology for LSIL or worse undergo a high-resolution anoscopy and biopsies within 1 month. Patients may be given a diagnosis and treatment at the second visit. Patients diagnosed with HSIL may undergo SOC treatment or enroll in additional studies when they are open to accrual
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of California, San FranciscoSan Francisco, CA
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Who Is Running the Clinical Trial?
University of California, San FranciscoLead Sponsor
National Cancer Institute (NCI)Collaborator
US-Latin American-Caribbean HIV/HPV-Cancer Prevention Clinical Trials Network (ULACNet)Collaborator
References
Screening anal dysplasia in HIV-infected patients: is there an agreement between anal pap smear and high-resolution anoscopy-guided biopsy? [2022]The purpose of this study was to analyze the agreement between anal Pap smear and high-resolution anoscopy-guided biopsy in diagnosing anal dysplasia in HIV-infected patients.
The use of molecular markers for cervical screening of women living with HIV in South Africa. [2022]To determine the performance of molecular screening strategies for detection of cervical intraepithelial neoplasia grade 3 or worse (CIN3+) in comparison with cytology screening in women living with HIV.
[Performance by cytology and hybrid capture II in screening for high-grade squamous intraepithelial lesions in women with HIV]. [2022]HIV-infected women are at increased risk of developing high-grade squamous intraepithelial lesions (HSIL), the precursor lesions for cervical cancer. This study estimated and compared the performance of cytology and hybrid capture II in screening for precursor lesions of cervical cancer among HIV-infected women. The study population consisted of women from the open prospective cohort at the Evandro Chagas Clinical Research Institute, Oswaldo Cruz Foundation (IPEC/Fiocruz). Colposcopy and histology were considered jointly in defining the gold standard. Cytology showed 31.8% sensitivity and 95.5% specificity, while hybrid capture II showed higher sensitivity (100%) and lower specificity (52%). The positive likelihood ratio was 7.1 for cytology and 2.1 for hybrid capture II, while the negative likelihood ratio was 0.7 for cytology and 0.0 for hybrid capture II.
Anal human papillomavirus DNA in women at a colposcopy clinic. [2012]To describe the type-specific prevalence of anal and cervical human papillomavirus (HPV) infections and the cytology in HIV-negative women without a history of cervical cancer, attending a colposcopy clinic. To examine if an HPV positive anal smear is related to anal pathology and consequently indicative for further examinations (high resolution anoscopy, anal biopsy).
Use of human papillomavirus genotyping and biomarkers for targeted screening of anal dysplasia in human immunodeficiency virus-infected patients. [2022]Screening for anal dysplasia in human immunodeficiency virus (HIV)-infected patients is not standardized. High-resolution imaging is not adequate for mass screening, and anal cytology requires expertise. New biomarkers, selected because of their use in cervical cancer mass screening, have been originally tested for targeted and easy-to-perform screening.
Digital tools for collecting data from cervigrams for research and training in colposcopy. [2019]Colposcopy is a critical part of gynecologic practice but has documented deficiencies, including lack of correlation between the colposcopic appearance and the severity of underlying neoplasia, limited reproducibility, and difficulty in the optimal placement of colposcopically directed biopsies. In a collaborative effort to improve colposcopy, we are analyzing digitized cervigram images from National Cancer Institute-funded studies. Specifically, the National Cancer Institute has collected close to 100,000 cervigrams, digitized to create a database of images of the uterine cervix for research, training, and education. In addition to the cervigram images, this database contains clinical, cytologic, and molecular information at multiple examinations of 15,000 women, with password and ID labeling strategies to protect patient privacy. The National Library of Medicine has designed two web-accessible software tools. The Boundary Marking Tool allows experts on colposcopy to perform an evaluation of the pictures and to mark boundary regions of normal and abnormal regions of the uterine cervix; these evaluations are collected and saved in the database. The Multimedia Database Tool enables retrieval of test and image biomedical data according to specific queries, for example, all women with cervical intraepithelial neoplasia 3 whose cytologic results are atypical squamous cells of undetermined significance. The resource soon will be available as an open resource, via a teaching tool coordinated by a database manager, which will permit a variety of applications for teaching and research. In this article, we describe the perceived need for the resource and its components.
How Colposcopy Misses Invasive Cervical Cancer: A Case Report from the IMPROVE-COLPO Study. [2020]Colposcopy with biopsy is pivotal to cervical cancer prevention programs as it is called to identify the precancerous lesions on patients that screen positive. We present a cervical cancer case from IMPROVE-COLPO, a postmarketing, multicenter, two-arm observational study on US community colposcopy that collects outcomes with the adjunctive Dynamic Spectral Imaging (DSI) in its prospective arm. A 45-year-old woman was seen for suffering of heavy periods. She had cytology of Atypical Squamous Cells of Undetermined Significance (ASC-US) and was Human Papillomavirus (HPV) positive. Her colposcopy did not recognize the underlying condition and opted for no biopsy. The DSI assessment led to a biopsy of a lesion challenging traditional colposcopic templates: small, away from the cervical os, with slow acetowhitening development. Pathology review revealed the presence of invasive squamous carcinoma. In the era of sensitive screening, it is concerning that invasive cancers can challenge colposcopy and that the way to improve colposcopy is to collect multiple biopsies from each patient. The case presented indicates that the adjunctive objective assessment by DSI increases reassurance that observations outside of traditional standard visual templates are not underestimated or ignored.
Acceptability of high-resolution anoscopy for anal cancer screening in HIV-infected patients. [2019]HIV-infected individuals are at increased risk of anal cancer. Screening for anal cancer precursors using high-resolution anoscopy (HRA) may be clinically beneficial. In this study, we examined patient tolerability of this procedure.
Treatment of Cervical Dysplasia by Clinicians Who Perform Colposcopy in German-speaking Countries - a Questionnaire-based Study. [2020]Introduction In connection with the reorganisation of cervical carcinoma screening, the importance of colposcopy as an integral part of the planned series of clarification testing will greatly increase. Quality standards for performing the colposcopic examination should therefore be defined in detail. A precondition for this is surveying the current standard in clinical practice. The objective of this study was to evaluate the current practice of colposcopy and conisation in Germany by means of a questionnaire aimed at gynaecologists who perform colposcopies in order to document the actual therapeutic standard of treatment of cervical dysplasia. Materials and Methods Gynaecologists were invited via e-mail or during events to participate in a web-based survey. The questionnaire contained 38 questions on management before, during and after the examination as well as questions on the technical implementation of colposcopy and conisation. Results From February 2018 to April 2018, 961 e-mails were sent. A response was received in 197 cases (response rate 20.5%). Responses were received for another 40 questionnaires during events (response rate approx. 80%). After taking the inclusion criteria into account, 160 questionnaires were evaluated. The majority of those surveyed take an average of 2 cervical biopsies (67.3%) and nearly all of those surveyed (94.5%) do not use any local anaesthetic. As a standard method for removing cervical precancerous cells, most of the physicians surveyed perform a loop excision with the electrosurgical loop (91.2%) under colposcopic visualisation (61.2%) under general anaesthesia (92.5%). Postoperative bleeding prophylaxis by means of tamponade is performed only in 27.6% of all cases. Conclusion A differential colposcopy with two colposcopically targeted biopsies and treatment with the electrosurgical loop are the methods most frequently used by clinicians who perform colposcopy in Germany. A uniform procedure should be defined in detail within the scope of directives or guidelines.
Practising high-resolution anoscopy. [2022]The incidence of anal cancer is increasing in the general population among both men and women. The incidence is particularly high among men who have sex with men and HIV-infected men and women. Anal cancer is similar to cervical cancer and is associated with human papillomavirus (HPV). Anal cancer is potentially preventable through primary prevention with HPV vaccination or secondary prevention. Secondary prevention is modelled after cervical cancer, where cytology is used as a screening tool to identify women who need colposcopy. Colposcopy includes magnification of the cervix, which, along with acetic acid and Lugol's solution, is used to visualise and biopsy potentially precancerous lesions, enabling treatment before progression to cervical cancer. Anal cancer is likely preceded by high-grade anal intraepithelial neoplasia (HGAIN), and a colposcope with acetic acid and Lugol's solution may similarly be used to visualise HGAIN to permit biopsy and treatment in an effort to prevent anal cancer. To distinguish it from cervical colposcopy, this technique is called high-resolution anoscopy (HRA). Many of the features that distinguish low-grade AIN from HGAIN are similar to those of the cervix, but HRA poses several additional challenges compared with cervical colposcopy. These include uneven topography; obscuring of lesions due to haemorrhoids, folds, stool or mucus; or lesions being located at the base of folds and anal glands. Consequently, a long learning curve is typically required before becoming fully competent in this technique. The technique of HRA, its uses and challenges in prevention of anal cancer are described in this article.
The Accuracy of Anal Swab-Based Tests to Detect High-Grade Anal Intraepithelial Neoplasia in HIV-Infected Patients: A Systematic Review and Meta-analysis. [2023]The incidence of high-risk human papillomavirus (HR-HPV)-induced anal cancer is increasingly problematic among HIV-positive patients. Anal cancer is preceded by precursor lesions, anal intraepithelial neoplasia (AIN). AIN detection requires high-resolution anoscopy, a cumbersome and time-consuming procedure. We aggregated evidence on anal swab-based tests to detect AIN in HIV-positive patients.
High-resolution anoscopy: clinical features of anal intraepithelial neoplasia in HIV-positive men. [2013]High-resolution anoscopy is increasingly advocated to screen HIV+ men who have sex with men for anal cancer and its precursor lesions, anal intraepithelial neoplasia. A systematic comparison between clinical features and the histopathology of suspect lesions is lacking.
Screening for Squamous Cell Anal Cancer in HIV Positive Patients: A Five-Year Experience. [2019]Potential screening modalities for early diagnosis of squamous cell anal cancer (SCC) in HIV patients include digital anorectal examination (DARE), anal Papanicolaou testing (Pap test), human papilloma virus (HPV) co-testing, and high-resolution anoscopy. The aim of this study was to demonstrate the results of a five-year screening program for SCC in HIV patients.
Elements of an anal dysplasia screening program. [2012]The incidence of anal cancer in HIV-infected men who have sex with men (MSM) is highly elevated compared to the general population, as is the incidence of its precursor lesion, high-grade anal intraepithelial neoplasia (HGAIN). MSM in general and other immunocompromised populations are also at higher risk. Treatment of HGAIN may prevent development of cancer, similar to the decrease in cervical cancers that has occurred since the advent of cervical cancer screening programs in women. Cervical cancer screening tools have been adapted and validated for screening, diagnosis, and treatment of anal HGAIN. Anal cancer screening programs have now been available for more than a decade, although they are not yet standards of care. Incorporating screening procedures into practice depends on the available resources in a particular community. This article discusses the procedures for anal cancer screening including cytology, digital anal rectal examinations, high-resolution anoscopy, and biopsy.