Ignite Creation Date:
2025-12-25 @ 3:24 AM
Ignite Modification Date:
2026-01-10 @ 1:22 AM
Study NCT ID:
NCT03396705
Status:
TERMINATED
Last Update Posted:
2022-04-07
First Post:
2018-01-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Liver Regeneration
Sponsor:
University Health Network, Toronto
Organization:
Study Overview
Official Title:
Understanding the Molecular Basis of Normal Liver Regeneration
Status:
TERMINATED
Status Verified Date:
2022-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Poor recruitment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The liver is the only visceral organ with a tremendous capacity to regenerate. We don't yet understand how normal liver regeneration occurs (on a molecular level) or how to distinguish between normal and "abnormal"/neoplastic regeneration. This study will characterize the role of the different liver cell types in the regeneration process and will examine gene expression changes in the various liver cell types.
Detailed Description:
New studies are demonstrating that rodent models of the liver and liver disease are inadequate. The human liver is quite different and needs to be studied directly. The cell expression of human liver cells during regeneration has many implications for treatment of patients with cirrhosis and cancer.
This study will characterize the role of the different liver cell types in the regeneration process and will examine gene expression changes in the various liver cell types. We hypothesize that there is significant crosstalk among hepatocytes, macrophages, and T-cell subsets in the human liver, stimulating the regenerative process.
Tissue will be obtained from serial biopsies of "healthy" liver that is regenerating in patients who undergo liver resection for metastatic colorectal cancer. All participants must first provide written informed consent and meet study eligibility criteria. The first tissue sample will be collected intraoperatively, then serial fine-needle aspiration biopsies (FNAB) will be performed approx. 1 week following surgery, and 1 month following surgery. Liver regeneration will also be assessed using routine imaging of the liver at approx. 3 months.
Retrospective (previously collected diagnostic or biobanked) tissue is also being included for study, given lower than anticipated enrollment.
This study will characterize the role of the different liver cell types in the regeneration process and will examine gene expression changes in the various liver cell types. We hypothesize that there is significant crosstalk among hepatocytes, macrophages, and T-cell subsets in the human liver, stimulating the regenerative process.
Tissue will be obtained from serial biopsies of "healthy" liver that is regenerating in patients who undergo liver resection for metastatic colorectal cancer. All participants must first provide written informed consent and meet study eligibility criteria. The first tissue sample will be collected intraoperatively, then serial fine-needle aspiration biopsies (FNAB) will be performed approx. 1 week following surgery, and 1 month following surgery. Liver regeneration will also be assessed using routine imaging of the liver at approx. 3 months.
Retrospective (previously collected diagnostic or biobanked) tissue is also being included for study, given lower than anticipated enrollment.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: