NCT03396705

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2017

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 12, 2017

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 4, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 11, 2018

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 19, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 19, 2019

Completed
Last Updated

April 7, 2022

Status Verified

March 1, 2022

Enrollment Period

1.5 years

First QC Date

January 4, 2018

Last Update Submit

March 30, 2022

Conditions

Liver DiseasesLiver Cancer

Outcome Measures

Primary Outcomes (1)

  • Gene expression

    gene expression

    week 1 post-resection

Interventions

Liver BiopsyPROCEDURE

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients undergoing partial hepatectomy for colorectal cancer metastases, and meeting the eligibility criteria will be invited to participate.

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Health Network

Toronto, Ontario, M5G 2C4, Canada

Location

MeSH Terms

Conditions

Liver DiseasesLiver Neoplasms

Condition Hierarchy (Ancestors)

Digestive System DiseasesDigestive System NeoplasmsNeoplasms by SiteNeoplasms

Study Officials

  • Mamatha Bhat, MD

    University Health Network, Toronto

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 4, 2018

First Posted

January 11, 2018

Study Start

September 12, 2017

Primary Completion

March 19, 2019

Study Completion

March 19, 2019

Last Updated

April 7, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)