跳至主要内容
临床试验/NCT04854343
NCT04854343Unknown不适用

SLPI: a Novel Biomarker of Prostate Cancer

University of Florence1 个研究点 分布在 1 个国家目标入组 280 人开始时间: 2020年12月1日最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Simone Morselli

PhD Student

University of Florence

研究点 (1)

Loading locations...

相似试验