Seville Cohort of People Living With HIV at Risk for Anal Cancer

NCT03713229 | Enrolling By Invitation

• 1 other identifier: SeVIHanal Cohort
• Study Type: observational
• Target: 3,000
• Locations: 1 country
• Sites: 1

Brief Summary

There is increasing awareness of augmenting risk of anal cancer in people living with HIV, especially among men who have sex with men (MSM). High resolution anoscopy (HRA) represents the gold standard to detect pre-cancerous anal high-grade squamous intraepithelial lesions (HSIL), however, the procedure is time-consuming, costly and, most importantly, the learning curve is very flat. This yields a poor implementation of anal screening and, likely, to an excess of otherwise preventable anal cancer. Other screening methods include digital ano-rectal examination, anal-rectal cytology and human papillomavirus (HPV) genotyping, since infection with high-risk HPV genotypes has been identified as the main reason for the development of HSIL. To date, there is no consensus in screening strategies. Furthermore, it remains unclear whether, in whom and to which extend the currently available topic and invasive treatment options for HSIL should be applied, given that the natural history of the development of anal cancer remains poorly understood. The present cohort study aims to provide 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.

Conditions

Anal Squamous Intraepithelial Neoplasia

Keywords

anal squamous intraepithelial lesions; anal squamous cell carcinoma; high-resolution anoscopy; liquid-based cytology; human papillomavirus; men who have sex with men; HIV infection; diagnostic performance

Outcome Measures

Primary Outcomes (2)

• Frequency of anal HSIL

  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

  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

Study Arms (3)

HIV-infected men who have sex with men

HIV-infected male patients who refer to conducting sexual risk practices that enable HPV transmission

Diagnostic Test: Screening for anal squamous intraepithelial lesions

HIV-infected men

HIV-infected male patients who neglect conducting sexual risk practices that enable HPV transmission

Diagnostic Test: Screening for anal squamous intraepithelial lesions

HIV-infected women

HIV-infected female patients disregarding sexual risk practices

Diagnostic Test: Screening for anal squamous intraepithelial lesions

Interventions

Screening for anal squamous intraepithelial lesions DIAGNOSTIC_TEST

digital-anorectal exam, liquid-based cytology, human papillomavirus testing, high-resolution anoscopy

HIV-infected men; HIV-infected men who have sex with men; HIV-infected women

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

HIV-infected patients seen at the sexually transmitted diseases/HPV consultancy of the Infectious Diseases Unit of the Virgen del Rocío Hospital in Seville, Spain.

You may qualify if:

• HIV infection as confirmed by ELISA and western blot

You may not qualify if:

• Unable to provide informed consent

Sponsors & Collaborators

• Hospitales Universitarios Virgen del Rocío: lead
• Instituto de Biomedicina de Sevilla: collaborator

Study Sites (1)

Virgen del Rocio University Hospital

Seville, 41013, Spain

Location

Related Publications (4)

• 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.

  PMID: 34339628 RESULT

• 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.

  PMID: 34694279 RESULT

• 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.

  PMID: 30770528 RESULT

• 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.

  PMID: 30716543 RESULT

Biospecimen

Retention: SAMPLES WITH DNA

anal biopsy

MeSH Terms

Conditions

Anus Neoplasms; Homosexuality; HIV Infections

Interventions

Mass Screening

Condition Hierarchy (Ancestors)

Rectal Neoplasms; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Anus Diseases; Rectal Diseases; Sexuality; Sexual Behavior; Behavior; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis; Health Surveys; Surveys and Questionnaires; Data Collection; Epidemiologic Methods; Investigative Techniques; Diagnostic Services; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Public Health Practice

Study Officials

• Pompeyo Viciana, MD, PhD

  Clínica El Sur

  STUDY DIRECTOR

• Karin Neukam, PharmD, PhD

  Hospitales Universitarios Virgen del Rocío

  STUDY CHAIR

• César Sotomayor de la Piedra

  Hospitales Universitarios Virgen del Rocío

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PharmD, PhD

Study Record Dates

• First Submitted: October 18, 2018
• First Posted: October 19, 2018
• Study Start: September 1, 2010
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2030
• Last Updated: September 22, 2023

Record last verified: 2023-09

Locations

ES (1)