NCT01774643

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2013

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

January 22, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 24, 2013

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
7.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2022

Completed
Last Updated

January 10, 2023

Status Verified

January 1, 2023

Enrollment Period

2.2 years

First QC Date

January 22, 2013

Last Update Submit

January 8, 2023

Conditions

Pancreatic CancerLiver MetastasesTumor Tissue BiopsyBlood Samples

Keywords

Pancreatic cancerLiver metastasesTumor tissue biopsyBlood samplesXenograftsMurineGenomic profilingCirculating biomarkers

Outcome Measures

Primary Outcomes (4)

  • Number of patients with adverse events due to biopsies

    Monitoring adverse events during trial related to biopsies

    up to 2 years

  • Number of successful xenografts

    determine the "take rate" or success of establishing xenografts

    up to 2 years

  • 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

  • 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

Study Arms (1)

Pancreatic cancer with liver metastases

Tumor tissue biopsy, blood samples

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Pancreatic cancer patients with liver metastases

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Princess Margaret Cancer Centre

Toronto, Ontario, M5G 2M9, Canada

Location

Biospecimen

Retention: SAMPLES WITH DNA

Tumor tissue

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System Diseases

Study Officials

  • Neesha Dhani, M.D.

    Princess Margaret Cancer Centre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 22, 2013

First Posted

January 24, 2013

Study Start

January 1, 2013

Primary Completion

April 1, 2015

Study Completion

November 1, 2022

Last Updated

January 10, 2023

Record last verified: 2023-01

Locations

CA(1)