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Completed

NCT Number: NCT01774643

A Study of Pancreatic Cancer in Xenografts From Liver Metastases

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.

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Key information

Conditions

Pancreatic Cancer Blood Samples Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Liver Metastases Neoplasms Neoplasms by Site Pancreatic Diseases Pancreatic Neoplasms Tumor Tissue Biopsy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Princess Margaret Cancer Centre

Toronto, Ontario, M5G 2M9, Canada

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Number of patients with adverse events due to biopsies

    Time frame: up to 2 years

    Monitoring adverse events during trial related to biopsies

  2. Number of successful xenografts

    Time frame: up to 2 years

    determine the "take rate" or success of establishing xenografts

  3. Number of similarities and differences between original patient tumor sample with xenograft sample

    Time frame: up to 2 years

    complete histological and molecular comparison of original patient sample with murine xenograft

  4. Engraftment rate compared to clinical data (response to treatment, disease-free survival, overall survival)

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2015
Study completion
2022
First posted
Jan 24, 2013
Registry last updated
Jan 10, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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