A Study of Pancreatic Cancer in Xenografts From Liver Metastases

Pancreatic Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01774643
• Other study ID #: XENO-METPANC
• Status: Completed
• Start date: January 2013
• Est. completion date: November 2022

Study information

• Verified date: January 2023
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: November 2022
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Blood Samples
• Liver Metastases
• Liver Neoplasms
• Neoplasm Metastasis
• Pancreatic Cancer
• Pancreatic Neoplasms
• Tumor Tissue Biopsy

Locations

Country	Name	City	State
Canada	Princess Margaret Cancer Centre	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients with adverse events due to biopsies	Monitoring adverse events during trial related to biopsies	up to 2 years
Primary	Number of successful xenografts	determine the "take rate" or success of establishing xenografts	up to 2 years
Primary	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
Primary	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