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

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ClinicalTrials.gov Identifier: NCT03713229
Recruitment Status : Enrolling by invitation
First Posted : October 19, 2018
Last Update Posted : November 7, 2018
Sponsor:
Collaborator:
Dr. Karin Neukam
Information provided by (Responsible Party):
Pompeyo Viciana, Hospitales Universitarios Virgen del Rocío

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.

Condition or disease Intervention/treatment
Anal Squamous Intraepithelial Neoplasia Diagnostic Test: Screening for anal squamous intraepithelial lesions

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. iIn 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.


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Study Type : Observational
Estimated Enrollment : 3000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: 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
Actual Study Start Date : September 1, 2010
Estimated Primary Completion Date : December 31, 2025
Estimated Study Completion Date : December 31, 2030

Resource links provided by the National Library of Medicine


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
Diagnostic Test: Screening for anal squamous intraepithelial lesions
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
Diagnostic Test: Screening for anal squamous intraepithelial lesions
digital-anorectal exam, liquid-based cytology, human papillomavirus testing, high-resolution anoscopy

HIV-infected women
HIV-infected female patients disregarding sexual risk practices
Diagnostic Test: Screening for anal squamous intraepithelial lesions
digital-anorectal exam, liquid-based cytology, human papillomavirus testing, high-resolution anoscopy




Primary Outcome Measures :
  1. 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.

  2. 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).


Biospecimen Retention:   Samples With DNA
anal biopsy


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

Inclusion Criteria:

  • HIV infection as confirmed by ELISA and western blot

Exclusion Criteria:

  • Unable to provide informed consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03713229


Sponsors and Collaborators
Hospitales Universitarios Virgen del Rocío
Dr. Karin Neukam
Investigators
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Principal Investigator: Pompeyo Viciana, MD, PhD Hospitales Universitarios Virgen del Rocío
Principal Investigator: Karin Neukam, PharmD, PhD Hospitales Universitarios Virgen del Rocío

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Responsible Party: Pompeyo Viciana, MD, PhD, Hospitales Universitarios Virgen del Rocío
ClinicalTrials.gov Identifier: NCT03713229     History of Changes
Other Study ID Numbers: SeVIHanal Cohort
First Posted: October 19, 2018    Key Record Dates
Last Update Posted: November 7, 2018
Last Verified: October 2018

Keywords provided by Pompeyo Viciana, Hospitales Universitarios Virgen del Rocío:
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

Additional relevant MeSH terms:
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Carcinoma in Situ
Anus Neoplasms
Squamous Intraepithelial Lesions of the Cervix
Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Anus Diseases
Rectal Diseases
Uterine Cervical Dysplasia
Precancerous Conditions
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female