Screening for Anal Cancer and Precancer in Women With HIV (SANCA)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Positive anal hrHPV test
研究概览
简要总结
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.
详细描述
Aims and purposes:
(I) 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.
(II) Assess the combination of Human Papilloma Virus (HPV) type and HPV ct values as a tool for stratifying clinical management (II) Investigate the predictive potential of DNA methylation markers for the clinical progression of precancerous anal lesions in women with HIV (III) Assess circulating HPV DNA in plasma as a highly specific pre-diagnostic biomarker for anal cancer
SUB PROJECT A Study design: Prospective register-based cohort study Study population: All women with HIV from the age of 45 attending routine appointments at the out-patient HIV departments at Karolinska University Hospital in Stockholm (n=707), the South Hospital in Stockholm (n=163), and Sahlgrenska University Hospital in Gothenburg (n=188), Sweden. Patients that fill the inclusion criteria will be identified from the National HIV registry InfCareHIV.
Overall aim: To assess if anal cancer screening, as proposed by the International Anal Neoplasia Society, is feasible (i.e. practical, acceptable, cost-effective) in women 45+ living with HIV Specific research questions
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Women who have had anal cancer
- •women who have had rectal amputation
结局指标
主要结局
Positive anal hrHPV test
时间窗: at inclusion and through study completion, an average of 1 year
Number of participants with positive anal hrHPV test
次要结局
- 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)
- HPV ct levels(at inclusion and through study completion, an average of one year)
研究者
Christina Carlander
PI
Karolinska Institutet