Role of host cell DNA Methylation Analysis in predicting non-Regression or regression of high-grade anal Intraepithelial NEoplasia in HIV+ men (MARINE) trial

Amsterdam UMC, location AMC0 sites200 target enrollmentTBD

Overview

No summary available.

Registry

who.int

Start Date

TBD

End Date

TBD

Last Updated

2 years ago

Study Type

Observational non invasive

Sponsor

Amsterdam UMC, location AMC

•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;

•\- 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.