Pilot Study With the Aim to Quantify a Stress Protein in the Blood and in the Urine for Early Diagnosis of Malgnant Solid Tumors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 71
- 试验地点
- 1
- 主要终点
- concentration of HSP70 exosomes in the blood and urine
研究概览
简要总结
Recent studies shows that extracellular vesicles (named "exosomes") released by cancer cells exhibit at their membrane the stress protein HSP70, contrary to exosomes released by normal cells. These exosomes ("HSP70-exosomes") have a very important role in intercellular communication and have specific biological functions that can promote tumor progression. They are found in the different biological fluids such as blood and urine.
We have developed a protocol able to isolate exosomes in blood and urine. We also demonstrated that only exosomes derived from cancer cell have HSP70 at their membrane. Those results strongly suggest that we can only identify exosomes with HSP70 at the membrane in patients with cancer.
Detection of HSP70-exosomes in the diagnosis of patients is a promising pathway of research. Because a cancer cell can releases a large amount of exosomes (several billion) and since its appearance, our approach will allow to earlier detect cancer with respect to the use of imaging and circulating tumor cells (CTCs), which remains a rare event (about one CTC of 1 billion cells).
The aim of this study is to demonstrate that HSP70-exosomes could be used for early diagnosis of patients with malignant solid tumor. In order to demonstrate this, the objective of the study is to study blood and urine samples from 60 subjects with a malignant tumor and 20 healthy subjects (witness).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •for patients
- •Women newly diagnosed with either:
- •Infiltrating non-metastatic breast cancer (positive or negative HER2 status or hormone therapy)
- •Breast cancer with a first metastasis evolution (positive or negative HER2 status or hormone therapy).
- •Ovarian cancer stage III and IV,
- •Men and women who are newly diagnosed non-small cell lung cancer metastatic,
- •Age ≥18 years
- •Affiliation to a social security system,
- •Signed Informed consent.
排除标准
- •for patients:
- •Patient with another synchronous tumor,
- •Men with breast cancer,
- •Positive HIV and / or HBV and / or HCV serology
- •Patients unable to undergo a medical monitoring for geographical, social or psychological condition,
- •Pregnant or nursing women,
- •People enjoying a major protection system (including trusteeship and guardianship).
- •Inclusion criteria for healthy volonter
- •Men or women aged 50-70 years (mean age of onset of various cancers in the study)
- •Affiliation to a social security system,
- •Signed Informed consent.
- •Exclusion criteria for healthy volonter
- •history of cancer,
- •Positive HIV and / or HBV and / or HCV serology
- •Pregnant or nursing women,
- •People enjoying a major protection system (including trusteeship and guardianship).
研究组 & 干预措施
ill patient
Patient with a cancer disease
干预措施: blood samples (Other)
ill patient
Patient with a cancer disease
干预措施: Urine samples (Other)
Healthy volunter
Subject without any cancer pathology
干预措施: blood samples (Other)
Healthy volunter
Subject without any cancer pathology
干预措施: Urine samples (Other)
结局指标
主要结局
concentration of HSP70 exosomes in the blood and urine
时间窗: 1 year
次要结局
未报告次要终点