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Clinical Trial Summary

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.


Clinical Trial Description

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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03472716
Study type Observational
Source Centre Leon Berard
Contact
Status Active, not recruiting
Phase
Start date May 22, 2018
Completion date September 2023

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