Screening for Anal Cancer and Precancer in Women With HIV (SANCA)
ConditionAnal Canal Cancer
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age45+
SponsorKarolinska Institutet
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Women (biological sex) with HIV
45 years old or older
attending the out-patient HIV departments at Karolinska University Hospital in Stockholm, the South Hospital in Stockholm, and Sahlgrenska University Hospital in Gothenburg
Disqualifiers
Women who have had anal cancer
women who have had rectal amputation
Trial design
Design model
Single group
Treatments tested in this trial
anal HPV screening
Diagnostic testFrom 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.
Treatment groups
1,000 Participants
are divided into 1 treatment groupGroup A: Anal HPV testingOther 1 intervention
Trial outcomes
Primary outcomes
1
Positive anal hrHPV test
Number of participants with positive anal hrHPV test
Time frame
at inclusion and through study completion, an average of 1 yearSecondary outcomes
1
Low-grade (LSIL) and high-grade (HSIL) squamous intrepithelial lesions
Number of participants with Low-grade (LSIL) and high-grade (HSIL) squamous intrepithelial lesions
Time frame
at inclusion and through study completion, an average of one year2
Circulating HPV DNA level in plasma
Circulating HPV DNA level in plasma
Time frame
at inclusion and through study completion, an average of one year3
Host DNA methylation markers
Differences in methylation levels across the different histological categories and HPV status
Time frame
at inclusion and through study completion, an average of one year4
Number of cases of anal cancer prevented due to screening and early treatment of HSIL
Number of cases of anal cancer prevented due to screening and early treatment of HSIL
Time frame
ten yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Karolinska Institutet
Lead sponsor
Karolinska University Hospital
Collaborator
Stockholm South General Hospital
Collaborator
Sahlgrenska University Hospital
Collaborator
The Swedish Research Council
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: