Molecular Characterization of Penile Cancers in Developing Countries
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 3
- 主要终点
- Biomarker Profiling of Penile Carcinoma by NGS
研究概览
简要总结
This study explores penile squamous cell carcinoma (PSCC) in Brazil, a rare cancer associated with factors like poor hygiene and HPV infection, using next-generation sequencing to investigate its genomic profiles in 24 deceased patients with advanced PSCC.
详细描述
This study focuses on penile squamous cell carcinoma (PSCC), a rare cancer that is more prevalent in underdeveloped regions such as Africa, Asia, and South America, with Brazil having one of the highest incidence rates due to socioeconomic factors. PSCC is primarily associated with risk factors like poor local hygiene, smoking history, phimosis, and human papillomavirus (HPV) infection. The research aims to understand the genomic profiles of PSCC and their correlation with clinical characteristics, particularly in circumcised vs. non-circumcised populations in Brazil. The study will employ next-generation sequencing (NGS) on tumor specimens from 23 deceased patients with advanced PSCC who received treatment in Brazilian cancer sites.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Men ≥ 18 years of age;
- •Diagnosis of locally advanced or metastatic squamous-cell penile carcinoma;
- •Have received at least one treatment for advanced disease (surgery, radiotherapy and/or chemotherapy);
- •Available representative tumor block of formalin-fixed and paraffin-embedded (FFPE) archive, from primary or metastasis;
- •Patients must be already deceased at time of data collection.
排除标准
- •Patients without medical record available (lost, empty or irretrievable clinical information).
结局指标
主要结局
Biomarker Profiling of Penile Carcinoma by NGS
时间窗: Through study completion, an average of 2 years
The study employs state-of-the-art molecular analysis methods, including next-generation sequencing (NGS) using a targeted panel (FoundationONE CDx) that assesses 324 genes.
次要结局
未报告次要终点