Role of host cell DNA methylation analysis in predicting non-regression or regression of high-grade anal intraepithelial neoplasia in HIV+ men trial (MARINE)

Recruiting

• Conditions: Anal Cancer Precursors; High Grade Anal Intraepithelial Neoplasia; 10002112; 10047438; 10040900

• Registration Number: NL-OMON54464
• Lead Sponsor: Academisch Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 18 June 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 240

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 -
Histopathologically confirmed HGAIN (>=1 lesion); - Satisfactory HRA at
baseline, i.e. visualisation of entire transformation zone with biopsies of all
lesions;

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; -
Previous HPV vaccination (including participants of the VACCAIN-T and VACCAIN-P
trial); - Known active chronic infection such as hepatitis B or C - Diabetes
mellitus - Insufficient Dutch or English language skills. - Presence of any
diseases affecting the anal mucosa (fistulas, rhagades, eczema). - Signs of
current STI.

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified