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

NCT07059442 | Not Yet Recruiting

• 1 other identifier: 2024-06554
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Anal Canal Cancer

Keywords

HIV; Human papilloma virus; DNA methylation

Outcome Measures

Primary Outcomes (1)

• Positive anal hrHPV test

  Number of participants with positive anal hrHPV test

  at inclusion and through study completion, an average of 1 year

Secondary Outcomes (6)

• Low-grade (LSIL) and high-grade (HSIL) squamous intrepithelial lesions

  at inclusion and through study completion, an average of one year

• Circulating HPV DNA level in plasma

  at inclusion and through study completion, an average of one year

• Host DNA methylation markers

  at inclusion and through study completion, an average of one year

• Number of cases of anal cancer prevented due to screening and early treatment of HSIL

  ten years

• Number of HSIL cases detected and treated, and quality-adjusted life years gained from preventing cancer progression

  four years

Study Arms (1)

Anal HPV testing

OTHER

All included women will leave an anal HPV-self test

Diagnostic Test: anal HPV screening

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.

Anal HPV testing

Eligibility Criteria

• Age: 45 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women (biological sex) with HIV
• 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

You may not qualify if:

• Women who have had anal cancer
• women who have had rectal amputation

Sponsors & Collaborators

• Karolinska Institutet: lead
• Karolinska University Hospital: collaborator
• Stockholm South General Hospital: collaborator
• Sahlgrenska University Hospital: collaborator
• The Swedish Research Council: collaborator

Study Sites (1)

Karolinska Institutet

Stockholm, Sweden

Location

MeSH Terms

Conditions

Anal Canal Carcinoma

Study Officials

• Christina Carlander

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christina Carlander

CONTACT

+46708830761; christina.carlander@ki.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PI

Study Record Dates

• First Submitted: June 13, 2025
• First Posted: July 10, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2035
• Last Updated: July 10, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)