A Study of Pancreatic Cancer in Xenografts From Liver Metastases

Completed

• Conditions: Tumor Tissue Biopsy; Liver Metastases; Blood Samples; Pancreatic Cancer

• Registration Number: NCT01774643
• Lead Sponsor: University Health Network, Toronto

Brief Summary

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

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).

Study Timeline

• Study Start: 2013-01
• Study First Submitted: 2013-01-22
• Study First Submitted QC: 2013-01-22
• Study First Posted: 2013-01-24
• Primary Completion: 2015-04
• Study Completion: 2022-11
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-08
• Last Update Posted: 2023-01-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

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

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Trial Locations

Locations (1)

Princess Margaret Cancer Centre; 🇨🇦 Toronto, Ontario, Canada