Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

A Study of Pancreatic Cancer in Xenografts From Liver Metastases

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2013 by University Health Network, Toronto
Sponsor:
Information provided by (Responsible Party):
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT01774643
First received: January 22, 2013
Last updated: August 22, 2013
Last verified: August 2013
  Purpose

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
Pancreatic Cancer
Liver Metastases
Tumor Tissue Biopsy
Blood Samples

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by University Health Network, Toronto:

Primary Outcome Measures:
  • Number of patients with adverse events due to biopsies [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • Number of successful xenografts [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • Number of similiarities and differences between original patient tumor sample with xenograft sample [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Engraftment rate compared to clinical data (response to treatment, disease-free survival, overall survival) [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Tumor tissue


Estimated Enrollment: 25
Study Start Date: January 2013
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
Pancreatic cancer with 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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01774643

Contacts
Contact: Ria Sayat ria.sayat@uhn.ca

Locations
Canada, Ontario
Princess Margaret Cancer Centre Recruiting
Toronto, Ontario, Canada, M5G 2M9
Principal Investigator: Malcolm J. Moore, M.D.         
Sub-Investigator: Neesha Dhani, M.D.         
Sponsors and Collaborators
University Health Network, Toronto
Investigators
Principal Investigator: Moore Malcolm, M.D. Princess Margaret Cancer Centre
  More Information

No publications provided

Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT01774643     History of Changes
Other Study ID Numbers: XENO-METPANC
Study First Received: January 22, 2013
Last Updated: August 22, 2013
Health Authority: Canada: Ethics Review Committee

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

ClinicalTrials.gov processed this record on November 20, 2014