Pancreatic CancerNCT01774643
A Study of Pancreatic Cancer in Xenografts From Liver Metastases
An observational study of Pancreatic Cancer and Liver Metastases, run by University Health Network, Toronto at 1 site in Canada.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cancer, Liver Metastases, Tumor Tissue Biopsy
- How many people
- 31 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2013to Nov 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Pancreatic cancer patients with liver metastases
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Feasibility Study Of Developing Murine Primary Xenografts From Biopsies Of Liver Metastases In Patients With Advanced Pancreatic Cancer
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.
Read the 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).
- Keywords
- Pancreatic cancer, Liver metastases, Tumor tissue biopsy, Blood samples, Xenografts, Murine, Genomic profiling, Circulating biomarkers
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Pancreatic cancer with liver metastases | Tumor tissue biopsy, blood samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with adverse events due to biopsies
Monitoring adverse events during trial related to biopsies
Measured: up to 2 years
Number of successful xenografts
determine the "take rate" or success of establishing xenografts
Measured: 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
Measured: 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).
Measured: up to date of death from any cause
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2013 (estimated)
- Study startJan 2013
- Primary completionApr 2015
- Study completionNov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Neesha Dhani, M.D., Principal investigator, Princess Margaret Cancer Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01774643
- Sponsor's protocol ID
- XENO-METPANC
- Status last verified
- Jan 2023
- First submitted
- 22 Jan 2013
- Last updated
- 10 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility Study Of Developing Murine Primary Xenografts From Biopsies Of Liver Metastases In Patients With Advanced Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT01774643
- Acronym / sponsor ID
- XENO-METPANC
- Keywords
- Pancreatic cancer, Liver metastases, Tumor tissue biopsy, Blood samples, Xenografts, Murine, Genomic profiling, Circulating biomarkers
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Apr 2015 (actual)
- Study completion
- Nov 2022 (actual)
- First posted
- 24 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pancreatic cancer with liver metastases | – | –Tumor tissue biopsy, blood samples |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Pancreatic cancer patients with liver metastases
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of patients with adverse events due to biopsies
Time frame: up to 2 years
Monitoring adverse events during trial related to biopsies
Number of successful xenografts
Time frame: up to 2 years
determine the "take rate" or success of establishing xenografts
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
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Neesha Dhani, M.D. principal investigator
Princess Margaret Cancer Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pancreatic Cancer and Liver Metastases, run by University Health Network, Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with adverse events due to biopsies (time frame: up to 2 years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2023.