SLPI: a Novel Biomarker of Prostate Cancer
试验速览
- 阶段
- 不适用
- 入组人数
- 280
- 试验地点
- 1
- 主要终点
- SLPI and Molecular Features
研究概览
简要总结
Exploratory study of SLPI expression in human prostate cancer patients This is a no-profit exploratory study about the expression of SLPI in human prostate cancer patients that will enroll about 200 patients admitted for suspect prostate cancer to Careggi University Hospital. We will verify whether an increase SLPI levels in the sera may serve as biomarker of cancer progression.
详细描述
Prostate cancer (PC) is a heterogeneous disease that occurs more frequently in elderly men. Prostate cancer is usually localized and it has a slow progression; thus, the patient may not suffer from any symptom for years. However, a proportion of patients PC develops metastases and may become a clinically relevant disease that can show an aggressive behavior and, eventually, give metastases. In any event, since it is the most common male cancer in the Western countries, it is the second leading cause of cancer deaths in males. For this reason the identification of the molecular alterations determining the different clinical behaviors and of the associated biomarkers would be extremely useful.
The Secretory leukocyte protease inhibitor (SLPI) is a serine protease which best-defined function is to protect host tissues from the excessive damage by proteolytic enzymes released during inflammation. Recently SLPI has been found overexpressed in a variety of cancers (pancreatic, papillary thyroid, uterine cervix, endometrial, and ovarian cancer). In apparent contrast, SLPI has been found reduced in the sera (and tumor tissue) of prostate cancer patients in the respect of healthy subjects and of subjects with benign hyperplasia. However, SLPI has been found upregulated in castration resistant prostate cancer (CRPC) patients and in a subset of CRPC cell lines.
These data suggest that expression of SLPI in prostate cancer could be biphasic: underexpressed during the early stages and overexpressed during progression. This peculiar pattern of SLPI expression suggests that SLPI may play a role in prostate cancer pathogenesis and/or in determining its neoplastic features. In this respect, it is noteworthy that SLPI is located at 20q13.2 (HPC20 locus), a locus harboring prostate cancer susceptibility genes. Based on these data it is possible to hypothesize that prostate cancer progression could be associated, and possibly heralded, by the increase of SLPI.
This is an observational investigation of SLPI levels in blood and tissue samples of patients with prostate disease with the explorative goal to verify whether SLPI could be a potential biomarker of prostate cancer progression.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
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
- •Patients with prostate carcinoma.
- •Patients with Benign Prostatic Hyperplasia.
- •Male subjects older that 50 years without prostate or neoplastic diseases.
排除标准
- •Male subjects younger that 50 years without prostate disease.
- •Male subjects with neoplastic diseases either than prostate.
结局指标
主要结局
SLPI and Molecular Features
时间窗: Enrollment
Correlation between molecular features of prostate cancer and SLPI levels
SLPI and Pathological data
时间窗: Enrollment
Correlation between pathological data of prostate cancer and SLPI levels
SLPI and Clinical data
时间窗: through study completion, at least 15 months
Correlation between clinical data of prostate cancer and SLPI levels
次要结局
未报告次要终点
研究者
Simone Morselli
PhD Student
University of Florence
