Clinical Trials Directory

Trials / Terminated

TerminatedNCT03396705

Liver Regeneration

Understanding the Molecular Basis of Normal Liver Regeneration

Status
Terminated
Phase
Study type
Observational
Enrollment
2 (actual)
Sponsor
University Health Network, Toronto · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
PROCEDURELiver Biopsyliver tissue will be collected via core biopsy during liver resection surgery and post-operatively by fine needle aspiration biosy

Timeline

Start date
2017-09-12
Primary completion
2019-03-19
Completion
2019-03-19
First posted
2018-01-11
Last updated
2022-04-07

Locations

1 site across 1 country: Canada

Source: ClinicalTrials.gov record NCT03396705. Inclusion in this directory is not an endorsement.