NL-OMON54464
Recruiting
Not Applicable
Role of host cell DNA methylation analysis in predicting non-regression or regression of high-grade anal intraepithelial neoplasia in HIV+ men trial (MARINE) - MARINE
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Academisch Medisch Centrum
- Enrollment
- 240
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Study group (N\=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); \- histopathological confirmed HGAIN (\>\=1
- •lesion); \- satisfactory HRA at baseline, i.e. visualisation of entire
- •transformation zone with biopsies of all lesions; Substudy HIV\-positive group
- •(N\=20\): \- \>18 years of age \- Compliance to ART, undetectable viral load since
- •at least 1 year \- A low nadir CD4 cell count (\<200 cell/µl) \-
- •Histopathologically confirmed HGAIN (\>\=1 lesion); \- Satisfactory HRA at
- •baseline, i.e. visualisation of entire transformation zone with biopsies of all
- •lesions; Substudy HIV\-negative group (N\=20\) \- \>18 years of age \-
Exclusion Criteria
- •Study group: \- HGAIN covering more than 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. Substudy group (N\=40\): \- 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; \-
Outcomes
Primary Outcomes
Not specified
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