Evaluation of a New Method for Detecting Cancer Pathologies by Measuring the Activity of Different Glycosidases in Plasma in Patients With Localized Cancer - Pilot Study: B-GLUCANCER2
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 220
- 试验地点
- 1
- 主要终点
- To compare the levels of glycosidases measured in the blood samples of patients treated for a localized cancer (breast, lung or pancreatic cancer) compared to control patients without cancer.
研究概览
简要总结
The goal of this clinical trial is to develop a new cancer diagnostic and prognostic tool based on the dynamic and non-invasive detection of an exogenous volatile molecule, i.e., ethanol, from patients' samples.
Patients' blood plasma will be analyzed with a mixture of volatile organic compound-based probes, each targeting a specific glycosidase. The presence of a given glycosidase in a blood sample would thus be revealed by the detection of an ethanol isotope in the gas phase.
3 groups of patients with localized cancer (breast, prostate, pancreas) will be enrolled, as well as 1 group of patient without any cancer (control group).
For the patients, two 5ml plasma samples will be collected, one before and one after surgery for localized cancers. For healthy volunteers, only one 5ml plasma sample will be collected.
The primary objective will be to compare the levels of glycosidases measured in the blood of patients followed for localized cancer and referred for first surgery compared to control patients without cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- •Group 1: 40 patients with definitively diagnosed, untreated, localized solid breast cancer referred for initial surgical treatment.
- •Group 2: 40 patients with definitively diagnosed, untreated, localized solid lung cancer referred for initial surgical treatment.
- •Group 3: 40 patients with definitively diagnosed, untreated, localized solid pancreatic cancer referred for initial surgical treatment.
- •Group 4: 100 control patients with no cancer diagnosis or history of solid or hematological cancer.
排除标准
- •Refusal to participate in the research.
- •Patients benefiting from enhanced protection, namely: minors, pregnant/breastfeeding women, persons deprived of their liberty by a judicial or administrative decision, persons staying in a social care facility, adults under legal protection
- •Specific criteria for groups 1, 2, and 3:
- •Cancer patients undergoing oncological treatment.
- •Cancer not proven by anatomopathological examination.
研究组 & 干预措施
pulmonary cancer
干预措施: blood plasma sample (Biological)
no cancer
no history of cancer
干预措施: blood sampling (Biological)
breast cancer
干预措施: blood plasma sample (Biological)
pancreatic cancer
干预措施: blood plasma sample (Biological)
结局指标
主要结局
To compare the levels of glycosidases measured in the blood samples of patients treated for a localized cancer (breast, lung or pancreatic cancer) compared to control patients without cancer.
时间窗: before surgery and one month after surgery
次要结局
- Compare the seven glycosidase levels in patients with localized breast cancer versus cancer-free control patients.(one month)
- Compare the seven glycosidase levels in patients with localized pancreatic cancer versus cancer-free control patients.(one month)
- Compare the seven glycosidase levels in patients with localized lung cancer versus cancer-free control patients.(one month)
- Compare the seven glycosidase levels according to cancer location (lung versus breast, pancreas versus breast, lung versus pancreas).(one month)
- Compare glycosidase levels in cancer patients before and after surgery (regardless of location: breast, lung, or pancreatic cancer).(one month)