Role of host cell DNA Methylation Analysis in predicting non-Regression or regression of high-grade anal Intraepithelial NEoplasia in HIV+ men (MARINE) trial
- Conditions
- Anal cancer, anal intraepithelial neoplasia, HPV
- Registration Number
- NL-OMON22302
- Lead Sponsor
- Amsterdam UMC, location AMC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 200
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.
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Secondary outcomes are to assess:<br>•The histological outcome of each individual HGAIN lesion at the 6-, 12-, and 18-month follow-up visits. <br>•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.<br>•Overall HGAIN disease: the highest histological outcome of all HGAIN lesions combined at the 6-, 12-, 18, and 24-month follow-up visits.<br>•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.<br>•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.