A Study of Pancreatic Cancer in Xenografts From Liver Metastases

Study Overview
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Brief Summary
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This is a feasibility study to perform image-guided liver biopsies in 25 patients who have pancreatic cancer with liver metastasis (cancer in the pancreas that has spread to the liver). This will contribute with samples for the bio-bank (bank of tumors) and develop xenografts (human tumors growing in mice) for further analysis of genes.

Detailed Description
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This study might bring a better understanding of the metastatic pancreatic cancer and evaluate the differences between the metastatic and the primary pancreatic cancer (the type that does not have metastasis).

Official Title
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A Feasibility Study Of Developing Murine Primary Xenografts From Biopsies Of Liver Metastases In Patients With Advanced Pancreatic Cancer

Conditions
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Pancreatic Cancer, Liver Metastases, Tumor Tissue Biopsy, Blood Samples

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Minimum age of 18 years old Pancreatic cancer with liver metastasis No contraindication to image-guided biopsy of liver metastasis, including uncontrolled bleeding diathesis, uncontrolled malignant pain, inability to lie supine etc) and no significant hepatic dysfunction. Provide written informed consent ECOG 0,1 or 2 Exclusion Criteria: Inability to lie supine for more than 30 minutes ECOG 3 or more Serious medical risk factors involving any of the major organ systems or including uncontrolled bleeding diathesis, uncontrolled malignant pain, inability to lie supine etc) and no significant hepatic dysfunction.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Pancreatic cancer with liver metastases<br>Tumor tissue biopsy, blood samples | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with adverse events due to biopsies | Monitoring adverse events during trial related to biopsies | up to 2 years | 
| Number of successful xenografts | determine the take rate or success of establishing xenografts | up to 2 years | 
| Number of similarities and differences between original patient tumor sample with xenograft sample | complete histological and molecular comparison of original patient sample with murine xenograft | up to 2 years | 
| Engraftment rate compared to clinical data (response to treatment, disease-free survival, overall survival) | determine the correlation between engraftment rate and clinical data (response to treatment, disease-free survival, overall survival). | up to date of death from any cause | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Xenografts, Pancreatic cancer, Liver metastases, Tumor tissue biopsy, Blood samples, Murine, Genomic profiling, Circulating biomarkers