The Organ Transplant Recipient HPV and Skin Cancer Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,500
- 试验地点
- 3
- 主要终点
- Difference in prevalence, incidence and persistence of cervical HPV infection in female OTRs compared to immunocompetent controls.
研究概览
简要总结
Solid organ transplant recipients (OTRs) receive lifelong immunosuppressive therapy, which puts them at increased risk of cutaneous and mucosal cancers. In particular, OTRs have increased risk of skin cancer and cancers caused by human papillomavirus (HPV), including cervical cancer and oropharyngeal cancer. There is currently limited knowledge on risk factors for HPV infection and skin cancer in OTRs, and limited knowledge on the natural history of HPV infection and cervical neoplasia in OTRs compared with immunocompetent controls. With a continuously increasing number of OTRs, there is a growing need to improve our understanding of the long-term reactions to immunosuppression.
The overall aim of this study is to investigate long term effects of immunosuppression on cutaneous and mucosal epithelium in Danish OTRs, including the risk of skin dysplasia and skin cancer, cervical and oral HPV infection and HPV-related dysplasia and cancer in OTRs.
This study will be designed as a prospective observational cohort study based on clinical data and data from nationwide Danish registries. A total of 600 female OTRs, 300 male OTRs and 600 female controls will be included from Danish dermatology departments.
The study aims to provide knowledge relevant for improving prevention of skin- and HPV-related cancers in OTRs, including personalized screening recommendations according to individual patient risk.
详细描述
AIMS
The specific research objectives of this study are:
- To investigate the overall and type-specific prevalence, incidence and persistence of cervical HPV infection in OTRs compared to immunocompetent controls.
- To investigate the overall and type-specific prevalence of oral HPV infection in female OTRs compared to immunocompetent controls.
- To determine the role of lifestyle and clinical factors for the occurrence of cervical and oral HPV infection in female OTRs.
- To investigate the prevalence and incidence of HPV-related dysplasia and cancer in female OTRs compared with immunocompetent controls.
- To determine the role of lifestyle, clinical and organ transplantation-related factors for the prevalence and incidence of skin dysplasia in OTRs.
- To investigate associations between skin dysplasia and prevalence of cervical HPV infection and VZV infection in OTRs.
METHODS
The study will be designed as a clinical prospective cohort study. A total of 600 female OTRs, 300 male OTRs and 600 female immunocompetent controls will be included from the Departments of Dermatology at Bispebjerg, Gentofte and Roskilde Hospitals, Denmark.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Difference in prevalence, incidence and persistence of cervical HPV infection in female OTRs compared to immunocompetent controls.
时间窗: Evaluated at baseline and month 12
Number of women with cervical HPV infection measured by PCR test.
次要结局
- Difference in prevalence and incidence of HPV-related dysplasia and cancer in female OTRs compared to immunocompetent controls.(Evaluated at baseline and during up to 15 years after baseline.)
- Correlations between lifestyle factors, clinical factors and prevalence of skin dysplasia and cancer in OTRs.(Evaluated at baseline)
- Correlation between prevalence of cervical HPV infection and prevalence of skin dysplasia and cancer in OTRs.(Evaluated at baseline)
- Difference in prevalence of oral HPV infection in female OTRs compared to immunocompetent controls.(Evaluated at baseline)
- Correlations between lifestyle factors, clinical factors and occurrence of cervical HPV infection in female OTRs.(Evaluated at baseline)
- Correlation between Vitamin D and prevalence of skin dysplasia and cancer in OTRs.(Evaluated at baseline)
- Correlations between lifestyle factors, clinical factors and occurrence of oral HPV infection in female OTRs.(Evaluated at baseline)
- Correlations between skin pigmentation, facial solar lentigines and prevalence of skin dysplasia and cancer in OTRs.(Evaluated at baseline)
- Correlations between history of herpes zoster, prevalence of cervical HPV infection and prevalence of skin dysplasia and cancer in OTRs.(Evaluated at baseline)
- Difference in prevalence and incidence of skin cancer in female OTRs compared to immunocompetent controls.(Evaluated at baseline and during up to 15 years after baseline.)
研究者
Merete Haedersdal
Principal investigator
Bispebjerg Hospital