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Liver Regeneration

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ClinicalTrials.gov Identifier: NCT03396705
Recruitment Status : Enrolling by invitation
First Posted : January 11, 2018
Last Update Posted : December 12, 2019
Sponsor:
Information provided by (Responsible Party):
University Health Network, Toronto

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.

Condition or disease Intervention/treatment
Liver Diseases Liver Cancer Procedure: Liver Biopsy

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.

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Study Type : Observational
Estimated Enrollment : 10 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Intervention Details:
  • Procedure: Liver Biopsy
    liver tissue will be collected via core biopsy during liver resection surgery and post-operatively by fine needle aspiration biosy


Primary Outcome Measures :
  1. Gene expression [ Time Frame: week 1 post-resection ]
    gene expression



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients undergoing partial hepatectomy for colorectal cancer metastases, and meeting the eligibility criteria will be invited to participate.
Criteria

Inclusion Criteria:

  • willing and able to provide written informed consent
  • No history of liver disease or dysfunction

Exclusion Criteria:

  • Patients who receive chemotherapy within the 6 weeks prior to their hepatectomy and/or would be started on active chemotherapy within the first 4 weeks post-hepatectomy.
  • Patients requiring long-term anticoagulation

Information from the National Library of Medicine

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


Locations
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Canada, Ontario
University Health Network
Toronto, Ontario, Canada, M5G 2C4
Sponsors and Collaborators
University Health Network, Toronto
Investigators
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Principal Investigator: Mamatha Bhat, MD University Health Network, Toronto
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Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT03396705    
Other Study ID Numbers: 17-5311
First Posted: January 11, 2018    Key Record Dates
Last Update Posted: December 12, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Liver Diseases
Digestive System Diseases