- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03713229
Seville Cohort of People Living With HIV at Risk for Anal Cancer (SeVIHanal)
A Study to Screen for Anal Precancerous Squamous Intraepithelial Lesions and to Prevent Anal Cancer in a Real-life Setting of People Living With HIV at Different Risk: the Seville HIV Anal Cohort
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The development of anal precancerous squamous intraepithelial lesions (SIL) and cancer of the anus is mainly caused by infection with high-risk human papillomavirus genotypes (HR-HPV). There is increasing awareness of marked (40 to 130-fold) risk of anal cancer in people living with HIV, especially among men who have sex with men (MSM). With the changing scenario of comorbidities in the HIV-infected population, given the success of modern antiretroviral therapy, anal cancer has emerged as a leading neoplasia across different cohorts in Western countries. In 2014, almost 30000 people were newly diagnosed with HIV in Europe, the majority of cases (77%) being men. This was largely driven by HIV transmission between MSM, which accounted for 42% of all HIV diagnoses. Hence, the incidence of anal cancer is likely to increase in the years to come.
The number of experts who support the necessity of implementing wide programs of anal cancer screening in at-risk populations is rapidly growing. Indeed, both the European Guidelines for treatment of HIV-infected adults and the Guidelines of the Spanish AIDS Society (GESIDA) currently recommend the screening of anal cancer in HIV-infected subjects at risk. It is likely that in years to come, a general recommendation to screen for anal cancer in patients with different conditions associated with immunosuppression is established, as experienced in other populations. In this context, since HIV-negative MSM and women with a history of anogenital dysplasia, as well as transplant patients, exhibit excess risk of anal cancer, these populations have been typically screened in center with ongoing anal cancer screening programs.
Digital ano-rectal examination (DARE) is mainly accepted as the first screening procedure for anal high-risk SIL (HSIL), followed by anal-rectal cytology. Both represent simple methods, however, cytology shows an alarmingly low negative predictive value and furthermore, in case of an abnormal cytology, the patient is referred to high resolution anoscopy (HRA) for biopsy of acetowhite lugol-negative lesions in the anal epithelium, suggestive of HSIL. HRA performance is similar to cervical colposcopy, but unfortunately, the training process is by far longer, hampering its implementation and availability to highly-specialized centers with large cohorts of people living with HIV under care.
Although histological HSIL was identified as precursor of anal cancer, it remains unclear if, which and in whom treatment is indicated, since not all patients progress, a considerable proportion even regresses spontaneously and recurrence rates are high. Treatments currently available include topical imiquimod or 5-fluorouracil, as well as surgical treatment. Due to the lack of data, no consensus of HSIL management has been reached.
Taken together what was mentioned above, real-life data on the screening, management and follow-up of HIV-infected MSM is warranted for a better understanding of anal cancer in this setting.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Locations
-
-
-
Seville, Spain, 41013
- Virgen del Rocio University Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- HIV infection as confirmed by ELISA and western blot
Exclusion Criteria:
- Unable to provide informed consent
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
HIV-infected men who have sex with men
HIV-infected male patients who refer to conducting sexual risk practices that enable HPV transmission
|
digital-anorectal exam, liquid-based cytology, human papillomavirus testing, high-resolution anoscopy
|
HIV-infected men
HIV-infected male patients who neglect conducting sexual risk practices that enable HPV transmission
|
digital-anorectal exam, liquid-based cytology, human papillomavirus testing, high-resolution anoscopy
|
HIV-infected women
HIV-infected female patients disregarding sexual risk practices
|
digital-anorectal exam, liquid-based cytology, human papillomavirus testing, high-resolution anoscopy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Frequency of anal HSIL
Time Frame: 2007-2025
|
The proportion of patients with cancer of the anal squamous intraepithelial cells stage 0, defined as anal high-risk squamous intraepithelial lesions (HSIL) according to the Lower Anogenital Squamous Terminology.
|
2007-2025
|
Incidence of anal cancer
Time Frame: 2007-2025
|
Incidence rates per person-years of cancer of the anal squamous intraepithelial cells stage 1-4 observed over time as defined by the National Cancer Institute of the National Institutes of Health, US Department of Health and Human Services (www.cancer.gov).
|
2007-2025
|
Collaborators and Investigators
Collaborators
Investigators
- Study Director: Pompeyo Viciana, MD, PhD, Clínica El Sur
- Study Chair: Karin Neukam, PharmD, PhD, Hospitales Universitarios Virgen del Rocío
- Principal Investigator: César Sotomayor de la Piedra, Hospitales Universitarios Virgen del Rocío
Publications and helpful links
General Publications
- Wei F, Gaisa MM, D'Souza G, Xia N, Giuliano AR, Hawes SE, Gao L, Cheng SH, Dona MG, Goldstone SE, Schim van der Loeff MF, Neukam K, Meites E, Poynten IM, Dai J, Combes JD, Wieland U, Burgos J, Wilkin TJ, Hernandez AL, Iribarren Diaz M, Hidalgo-Tenorio C, Valencia Arredondo M, Nyitray AG, Wentzensen N, Chow EP, Smelov V, Nowak RG, Phanuphak N, Woo YL, Choi Y, Hu Y, Schofield AM, Woestenberg PJ, Chikandiwa AT, Hickey AC, de Pokomandy A, Murenzi G, Pere H, Del Pino M, Ortiz AP, Charnot-Katsikas A, Liu X, Chariyalertsak S, Strong C, Ong JJ, Yunihastuti E, Etienney I, Ferre VM, Zou H, Segondy M, Chinyowa S, Alberts CJ, Clifford GM. Epidemiology of anal human papillomavirus infection and high-grade squamous intraepithelial lesions in 29 900 men according to HIV status, sexuality, and age: a collaborative pooled analysis of 64 studies. Lancet HIV. 2021 Sep;8(9):e531-e543. doi: 10.1016/S2352-3018(21)00108-9. Epub 2021 Jul 30.
- Milanes Guisado Y, Sotomayor C, Fontillon M, Dominguez Castano A, Espinosa N, Roca C, Lopez-Cortes LF, Viciana P, Neukam K; SeVIHanal Study Group. Incidence Rate and Risk Factors for Anal Squamous Cell Carcinoma in a Cohort of People Living With HIV from 2004 to 2017: Implementation of a Screening Program. Dis Colon Rectum. 2022 Jan 1;65(1):28-39. doi: 10.1097/DCR.0000000000002218.
- Viciana P, Milanes-Guisado Y, Fontillon M, Dominguez Castano A, Sotomayor C, Espinosa N, Lopez-Cortes LF, Neukam K. High-risk Human Papilloma Virus Testing Improves Diagnostic Performance to Predict Moderate- to High-grade Anal Intraepithelial Neoplasia in Human Immunodeficiency Virus-infected Men Who Have Sex With Men in Low-to-Absent Cytological Abnormalities. Clin Infect Dis. 2019 Nov 27;69(12):2185-2192. doi: 10.1093/cid/ciz144.
- Neukam K, Milanes Guisado Y, Fontillon M, Merino L, Sotomayor C, Espinosa N, Lopez-Cortes LF, Viciana P; SeVIHanal Study Group. High-resolution anoscopy in HIV-infected men: Assessment of the learning curve and factors that improve the performance. Papillomavirus Res. 2019 Jun;7:62-66. doi: 10.1016/j.pvr.2019.01.003. Epub 2019 Feb 1.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SeVIHanal Cohort
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Anal Squamous Intraepithelial Neoplasia
-
Medtronic - MITGCompletedAnal Intraepithelial Neoplasia (AIN) | High-grade Squamous Intraepithelial Lesions (HSIL)United States
-
Fred Hutchinson Cancer CenterNational Cancer Institute (NCI)TerminatedHigh Grade Anal Canal Intraepithelial Neoplasia | High Grade Vulvar Squamous Intraepithelial LesionUnited States
-
David FinchLancashire Teaching Hospitals NHS Foundation TrustNot yet recruitingAnal Intraepithelial Neoplasia | Anal High-grade Squamous Intraepithelial Lesion | Anal HSIL
-
Johns Hopkins UniversityUniversity of Wisconsin, Madison; Frantz Viral Therapeutics, LLCCompletedPrecancerous Conditions | Human Papilloma Virus | Anal Dysplasia | HPV-Related Anal Intraepithelial Neoplasia | AIN2/3 | Artesunate | Alternative TreatmentUnited States
-
Medtronic - MITGCompletedHIV-negative Subjects With Intra-anal Intraepithelial Neoplasia Containing High-Grade Squamous Intraepithelial LesionsUnited States
-
Imperial College LondonRecruitingAnal Cancer | Anal Squamous Intraepithelial NeoplasiaUnited Kingdom
-
AIDS Malignancy ConsortiumNational Cancer Institute (NCI); The Emmes Company, LLC; Inovio PharmaceuticalsActive, not recruitingAnal Intraepithelial Neoplasia | High Grade Squamous Intraepithelial Neoplasia | HIV Positivity | Human Papillomavirus-16 Positive | Human Papillomavirus-18 PositiveUnited States, Puerto Rico
-
Shandong UniversityUnknownEsophageal Squamous Intraepithelial NeoplasiaChina
-
National Cancer Institute (NCI)Active, not recruitingCervical Intraepithelial Neoplasia Grade 2/3 | High Grade Cervical Intraepithelial Neoplasia | Cervical Squamous Cell Carcinoma In Situ | Cervical Squamous Intraepithelial Neoplasia 2United States
-
Hospital Universitari Vall d'Hebron Research InstituteUnknown
Clinical Trials on Screening for anal squamous intraepithelial lesions
-
Icahn School of Medicine at Mount SinaiMedical University of South Carolina; M.D. Anderson Cancer CenterRecruitingHPV-related Lower Genital Tract Neoplasias | HPV-related Anal Neoplasias | Early Stage Lower Genital Tract CancersUnited States
-
SanofiCompletedInsomnia | Sleep Initiation and Maintenance DisordersUnited States, France, Germany, Netherlands, Spain, Czech Republic, Mexico, United Kingdom, Argentina, Austria, Finland, Chile, Canada, Australia
-
National Cancer Institute (NCI)Unknown
-
Barbara Ann Karmanos Cancer InstituteNational Cancer Institute (NCI)CompletedMelanoma (Skin)United States
-
Hospices Civils de LyonRecruitingFibrous Dysplasia of BoneFrance
-
Felix GutierrezHospital Clinic of Barcelona; Hospital General Universitario Elche; Germans Trias... and other collaboratorsRecruiting
-
Fred Hutchinson Cancer CenterNational Cancer Institute (NCI); National Institute of Allergy and Infectious...TerminatedMyelodysplastic Syndromes | Leukemia | Graft Versus Host DiseaseUnited States