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A Study of Pancreatic Cancer in Xenografts From Liver Metastases

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ClinicalTrials.gov Identifier: NCT01774643
Recruitment Status : Active, not recruiting
First Posted : January 24, 2013
Last Update Posted : January 3, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease
Pancreatic Cancer Liver Metastases Tumor Tissue Biopsy Blood Samples

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 Type : Observational
Actual Enrollment : 31 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Feasibility Study Of Developing Murine Primary Xenografts From Biopsies Of Liver Metastases In Patients With Advanced Pancreatic Cancer
Study Start Date : January 2013
Actual Primary Completion Date : April 2015
Estimated Study Completion Date : June 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort
Pancreatic cancer with liver metastases
Tumor tissue biopsy, blood samples



Primary Outcome Measures :
  1. Number of patients with adverse events due to biopsies [ Time Frame: 2 years ]
  2. Number of successful xenografts [ Time Frame: 2 years ]
  3. Number of similiarities and differences between original patient tumor sample with xenograft sample [ Time Frame: 2 years ]
  4. Engraftment rate compared to clinical data (response to treatment, disease-free survival, overall survival) [ Time Frame: 2 years ]

Biospecimen Retention:   Samples With DNA
Tumor tissue


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Pancreatic cancer patients with liver metastases
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01774643


Locations
Canada, Ontario
Princess Margaret Cancer Centre
Toronto, Ontario, Canada, M5G 2M9
Sponsors and Collaborators
University Health Network, Toronto
Investigators
Principal Investigator: Neesha Dhani, M.D. Princess Margaret Cancer Centre

Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT01774643     History of Changes
Other Study ID Numbers: XENO-METPANC
First Posted: January 24, 2013    Key Record Dates
Last Update Posted: January 3, 2018
Last Verified: December 2017

Keywords provided by University Health Network, Toronto:
Pancreatic cancer
Liver metastases
Tumor tissue biopsy
Blood samples
Xenografts
Murine
Genomic profiling
Circulating biomarkers

Additional relevant MeSH terms:
Neoplasm Metastasis
Neoplasms, Second Primary
Pancreatic Neoplasms
Liver Neoplasms
Neoplastic Processes
Neoplasms
Pathologic Processes
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Liver Diseases