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Patients with urologic diseases of non tumoral origin

By an invasive technique keratin 14 has been identified as a prognostic factor in bladder cancer. This study aims to analyze whether through a non-invasive technique keratin 14 can be used as a diagnostic and prognostic marker for this cancer.

Detection of K14 in Bladder Cancer With a Non Invasive Technique

K14 in Urothelial Cells as a Pronostic and Diagnostic Marker in Bladder Cancer Patients Using a Non Invasive Technique.

Corporacion Parc Tauli

Medical Doctor

Adenocarcinoma

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Included patients will undergo 2 biological samples : a 5-ml blood sample included in the standard care and a tumoral sample (from the surgical exeresis or from the initial diagnosis biopsy). Patients with a confirmed pancreatic carcinoma will be followed during 18 months in this cohort. In case of relapse, patients will have 2 new biological samples (blood and tumoral).

5 ml blood sample and one tumoural sample (either a fresh biopsy or the initial diagnosis biopsy).

In case of relapse, new samples will be performed (blood and tumoral samples)

Biological Samples

DE LA FOUCHARDIERE Christelle, Dr

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.

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.

Blood sample (included in the standard care) at inclusion and in case of relapse.

Initial tumoral sample from the surgical exeresis or from the sample obtained for the initial diagnosis (metastases biopsies) and new tumoural sample in case of relapse

The βIG-H3 Protein: a New Marker in PANCreatic Adenocarcinoma (BIGHPANC)

The βIG-H3 Protein: a New Marker in PANCreatic Adenocarcinoma

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

Correlation between βig-h3 protein blood rate (ELISA) and the pancreatic adenocarcinoma TNM/UICC staging

Correlation between the βig-h3 protein expression intensity in the tumoural microenvironment and the immune infiltrate LT CD8+ of pancreatic adenocarcinoma

Correlation between βig-h3 protein expression intensity and patients clinical evolution (6-month objective response rate according to RECIST 1.1 criteria)

Correlation between βig-h3 protein expression intensity and Overall Survival

Correlation between βig-h3 protein expression intensity and Progression Free Survival

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Detection of K14 in Bladder Cancer With a Non Invasive Technique	NCT02027649	Bladder Cancer		18 Years -	Corporacion Parc Tauli
Detection of K14 in Bladder Cancer With a Non Invasive Technique	NCT02027649	Bladder Cancer		18 Years -	Corporacion Parc Tauli
The βIG-H3 Protein: a New Marker in PANCreatic Adenocarcinoma (BIGHPANC)	NCT03472716	Pancreas Adenoc...	Biological Samp...	18 Years -	Centre Leon Berard
The βIG-H3 Protein: a New Marker in PANCreatic Adenocarcinoma (BIGHPANC)	NCT03472716	Pancreas Adenoc...	Biological Samp...	18 Years -	Centre Leon Berard

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