Overview

This trial is active, not recruiting.

Conditions pancreatic cancer, liver metastases, tumor tissue biopsy, blood samples
Sponsor University Health Network, Toronto
Start date January 2013
End date April 2015
Trial size 31 participants
Trial identifier NCT01774643, XENO-METPANC

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
Tumor tissue biopsy, blood samples

Primary Outcomes

Measure
Number of patients with adverse events due to biopsies
time frame: 2 years
Number of successful xenografts
time frame: 2 years
Number of similiarities and differences between original patient tumor sample with xenograft sample
time frame: 2 years
Engraftment rate compared to clinical data (response to treatment, disease-free survival, overall survival)
time frame: 2 years

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

Official title A Feasibility Study Of Developing Murine Primary Xenografts From Biopsies Of Liver Metastases In Patients With Advanced Pancreatic Cancer
Principal investigator Moore Malcolm, M.D.
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).
Trial information was received from ClinicalTrials.gov and was last updated in March 2016.
Information provided to ClinicalTrials.gov by University Health Network, Toronto.