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|ClinicalTrials.gov Identifier: NCT03396705|
Recruitment Status : Enrolling by invitation
First Posted : January 11, 2018
Last Update Posted : December 12, 2019
|Condition or disease||Intervention/treatment|
|Liver Diseases Liver Cancer||Procedure: Liver Biopsy|
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.
|Study Type :||Observational|
|Estimated Enrollment :||10 participants|
|Official Title:||Understanding the Molecular Basis of Normal Liver Regeneration|
|Actual Study Start Date :||September 12, 2017|
|Estimated Primary Completion Date :||December 2020|
|Estimated Study Completion Date :||December 2021|
- Procedure: Liver Biopsy
liver tissue will be collected via core biopsy during liver resection surgery and post-operatively by fine needle aspiration biosy
- Gene expression [ Time Frame: week 1 post-resection ]gene expression
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03396705
|University Health Network|
|Toronto, Ontario, Canada, M5G 2C4|
|Principal Investigator:||Mamatha Bhat, MD||University Health Network, Toronto|