Liver Regeneration

Liver Cancer Clinical Trial

Official title:

Understanding the Molecular Basis of Normal Liver Regeneration

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03396705
• Other study ID #: 17-5311
• Status: Terminated
• Start date: September 12, 2017
• Est. completion date: March 19, 2019

Study information

• Verified date: March 2022
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: March 19, 2019
• Est. primary completion date: March 19, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Liver Cancer
• Liver Diseases

Intervention

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

Locations

Country	Name	City	State
Canada	University Health Network	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gene expression	gene expression	week 1 post-resection