Anal cancer, anal intraepithelial neoplasia, HPV
Conditions
Interventions
At baseline socio-demographic, medical, AIN, HIV, and sexual history will be recorded in an electronic Case Report Form (eCRF). At baseline and at six-monthly (±2 weeks) visits, during a total follow-
Sponsors
Amsterdam UMC, location AMC
Eligibility
Inclusion criteria
Inclusion criteria: - HIV+ patients of at least 18 years of age that are cisgender men, transgender men or transgender women and who have sex with men (further referred to as HIV+ MSM); -- Transgender men and women are an often neglected group in research, but also at risk for anal HPV . Because of the comparable risk profile, we assume that HIV+ transgender men and women who have sex with men have a comparable chance of progression to anal cancer as cisgender HIV+MSM. - histopathological confirmed HGAIN (=1 lesion); - satisfactory HRA at baseline, i.e. visualisation of entire transformation zone with biopsies of all lesions;
Exclusion criteria
Exclusion criteria: - HGAIN covering >50% of the circumference of the anal canal (progression to cancer of these patients is estimated as high and therefore withholding treatment would be unethical); - clinical suspicion for anal cancer, defined as palpable abnormalities at DARE and suspicion of invasion at MRI; - histopathological diagnosis of anal cancer; - history of anal cancer; - previous HPV vaccination (including participants of the VACCAIN-T and VACCAIN-P trial); - concomitant cancer; - insufficient Dutch or English language skills.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is the regression or non-regression dichotomy of each individual HGAIN lesion at baseline based on the histological outcome of the 24-months follow-up anal biopsy. The histological outcome is based on the LGAIN/HGAIN dichotomy according to the criteria, terminology and recommendations of the Lower Anogenital Squamous Terminology (LAST) Project. To follow-up each individual HGAIN lesion, its location is recorded along 8 segments (octants) along the circular transformation zone in the anal canal. Regression is defined as any biopsy-proven LGAIN, or no AIN lesion in the octant of a HGAIN lesion previously seen at baseline, or in one of the adjacent octants. If no lesion is visible upon HRA at 24 months, a biopsy is obtained at random from the octant where the HGAIN lesion was seen at baseline. HGAIN non-regression is defined as any biopsy-proven HGAIN lesion or anal cancer in the octant of a HGAIN lesion previously seen at baseline, or in one of the adjacent octants . | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes are to assess: • The histological outcome of each individual HGAIN lesion at the 6-, 12-, and 18-month follow-up visits. • The clinical outcome of each individual HGAIN lesion at the 6-, 12-, 18-, and 24-month follow-up visits, defined as a change in size measured by the number of octants of the anal surface affected. • Overall HGAIN disease: the highest histological outcome of all HGAIN lesions combined at the 6-, 12-, 18, and 24-month follow-up visits. • Overall HGAIN disease: the clinical outcome of all HGAIN lesions combined at the 6-, 12-, 18-, and 24-month follow-up visits, defined as a change in size of any HGAIN lesion , measured by the number of octants of the anal surface affected, including incident HGAIN lesions during, and in between follow-up visits. • Health-related quality of life (HRQoL) in the study group compared to the HRQoL control group at baseline, and at the 6- and the 24-month follow-up visits. | — |
Contacts
Public ContactFernando Dias Gonçalves Lima
Amsterdam UMC
Outcome results
None listed