Screening for Anal Cancer and Precancer in Women With HIV (SANCA)

Sponsor
Karolinska Institutet
Study ID
NCT07059442
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
FEMALE
Age
45 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • anal HPV screening — DIAGNOSTIC_TEST
    From all included women samples will be collected at the out-patient HIV departments including self-sampled vaginal swab for hrHPV testing and self-sampled anal swab for hrHPV. A blood sample will be taken for the analysis of circulating HPV DNA.

Study Details

The main aim of the SANCA study is to evaluate the feasibility, cost-effectiveness, and acceptability of implementing international anal cancer screening guidelines for women living with HIV in Sweden, integrating health economic and patient-centered approaches. Secondly the investigators wish to investigate the predictive potential of DNA methylation markers for the clinical progression of precancerous anal lesions in women with HIV, combining prospective molecular biology analysis with clinical data from registries.

Key Dates

Start date
Sep 1, 2025
Status verified
Jul 2025
Primary completion
Dec 31, 2028
Completion
Dec 31, 2035

Study Design

Enrollment
1,000 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING

Arms

  • Other: Anal HPV testing
    All included women will leave an anal HPV-self test

Primary Outcome Measure

Positive anal hrHPV test [ Time Frame: at inclusion and through study completion, an average of 1 year ]

Central Contacts