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Clinical Trials/NL-OMON54464
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

Academisch Medisch Centrum0 sites240 target enrollmentTBD

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.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
last year
Study Type
Observational invasive

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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