Liver DiseasesNCT03396705
Liver Regeneration
An observational study of Liver Diseases and Liver Cancer, run by University Health Network, Toronto at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Diseases, Liver Cancer
- What is being tested?
- Liver Biopsy
- Type of treatment
- Surgery or procedure
- How many people
- 2 participants
- Where
- 1 siteCanada
- Study dates
- 12 Sep 2017to 19 Mar 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing partial hepatectomy for colorectal cancer metastases, and meeting the eligibility criteria will be invited to participate.
Who may be able to join
- willing and able to provide written informed consent
- No history of liver disease or dysfunction
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Understanding the Molecular Basis of Normal Liver Regeneration
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.
Read the 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
- Liver Diseases, Liver Cancer
- Being tested
- Liver Biopsy
- Medical subject headings
- Liver Diseases, Liver Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liver BiopsyProcedure or surgery
liver tissue will be collected via core biopsy during liver resection surgery and post-operatively by fine needle aspiration biosy
What is being measured
The primary outcome is the main question the study is designed to answer.
Gene expression
gene expression
Measured: week 1 post-resection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2018
- Study start12 Sep 2017
- Primary completion19 Mar 2019
- Study completion19 Mar 2019
Why it stopped: Poor recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver DiseasesStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mamatha Bhat, MD, Principal investigator, University Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03396705
- Sponsor's protocol ID
- 17-5311
- Status last verified
- Mar 2022
- First submitted
- 4 Jan 2018
- Last updated
- 7 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Understanding the Molecular Basis of Normal Liver Regeneration
- ClinicalTrials.gov ID
- NCT03396705
- Acronym / sponsor ID
- 17-5311
- Conditions
- Liver Diseases, Liver Cancer
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Poor recruitment
- Enrolment
- 2 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- 12 Sep 2017 (actual)
- Primary completion
- 19 Mar 2019 (actual)
- Study completion
- 19 Mar 2019 (actual)
- First posted
- 11 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing partial hepatectomy for colorectal cancer metastases, and meeting the eligibility criteria will be invited to participate.
Key inclusion criteria (2 listed)
- willing and able to provide written informed consent
- No history of liver disease or dysfunction
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Liver Biopsyliver tissue will be collected via core biopsy during liver resection surgery and post-operatively by fine needle aspiration biosy | Procedure or surgery | – |
Primary outcome
Gene expression
Time frame: week 1 post-resection
gene expression
Results and safety
The study was stopped early (reason given: Poor recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mamatha Bhat, MD principal investigator
University Health Network, Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Diseases and Liver Cancer, run by University Health Network, Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 7 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Poor recruitment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gene expression (time frame: week 1 post-resection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2022.