The βIG-H3 Protein: a New Marker in PANCreatic Adenocarcinoma
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Evaluation of the correlation between the intensity of the protein βig-h3 expression at tumoural microenvironment and the TNM/UICC (from I to IV) of pancreatic adenocarcinoma lesion
研究概览
简要总结
The primary objective of this trial is to evaluate the correlation between the intensity of the protein big-h3 expression at tumoural microenvironment and the TNM/UICC staging (from I to IV) of pancreatic adenocarcinoma lesion.
详细描述
The pancreatic adenocarcinoma is the most common pancreatic cancer. Currently, it represents the fourth cause of death by cancer in France. The diagnosis is often realized when the disease is at an advanced stage because of its delayed clinical expression. Only 20% of the patients are diagnosed at a stage enabling a tumour resection.
Scientists discovered a protein playing a key role: the βig-h3 protein. In mouse models, this protein is present in several stages of the tumorigenesis. A mutation of the gene Kras leads to the development of PANin (Pancreatic Intraepithelial Neoplasia) type precancerous lesions. The βig-h3 protein is early and highly expressed in the stroma around these lesions and in the pancreatic adenocarcinoma stroma. Moreover, studies showed that protein neutralization leads to a tumour size reduction by increasing the CD8+anti-tumor activity.
This protein is detected in the blood serum of patients suffering from a pancreatic adenocarcinoma. So, this protein which is secreted by the extracellular matrix could be a predictive marker for the pancreatic adenocarcinoma.
In this prospective, multicentric non-interventional study, it is anticipated to recruit 80 patients (20 per TNM/UICC stage).
Included patients will undergo two samples: A blood sample (5 ml) and a tumour sample (surgical exeresis piece or tumour tissue obtained for the initial diagnosis). In case of relapse, new samples will be performed.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years at the day of consenting to the study
- •Patient with a potential pancreatic adenocarcinoma whatever the TNM/UICC stage
- •Systematic treatment not initiated
- •Signed and dated informed consent document.
排除标准
- •Pregnant or breastfeeding woman
- •Geographical, social or psychiatric reason preventing the patient from completing the study follow-up
结局指标
主要结局
Evaluation of the correlation between the intensity of the protein βig-h3 expression at tumoural microenvironment and the TNM/UICC (from I to IV) of pancreatic adenocarcinoma lesion
时间窗: At inclusion
Correlation between the intensity of the protein βig-h3 expression at tumoural microenvironment and the TNM/UICC (from I to IV) of pancreatic adenocarcinoma lesionimmunohistochemical analysis of pancreatic adenocarcinoma
次要结局
- Evaluation of the correlation between βig-h3 protein expression intensity and patients clinical evolution(Assessed up to 36 months)
- Evaluation of the correlation between the βig-h3 protein expression intensity in the tumoural microenvironment and the immune infiltrate LT CD8+ of pancreatic adenocarcinoma(At inclusion and upon relpase assessed up to 36 months)
- Evaluation of the the correlation between βig-h3 protein expression intensity and patients clinical evolution(Assessed up to 36 months)
- Evaluation of the correlation of βig-h3 protein blood rate and the pancreatic adenocarcinoma TNM/UICC staging(At inclusion and upon relpase assessed up to 36 months)