Liver TransplantNCT02798861
Controlled Attenuation Parameter (CAP) in Liver Allografts
An observational study of Liver Transplant and Liver Steatosis, run by Andres Duarte-Rojo at 3 sites in United States.
Trial summary
The primary aim is to determine the accuracy of CAP in the quantification of liver steatosis using liver biopsies as reference. Secondarily, investigators will correlate transient elastography (TE) and CAP results, analyze possible associations between CAP/TE and post-liver transplant (LT) clinical outcomes, and… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Liver Transplant, Liver Steatosis, Liver Disease
- What is being tested?
- Fibroscan 402/530
- Type of treatment
- Medical device
- How many people
- 160 participants
- Where
- 3 sitesUnited States
- Study dates
- 7 Sep 2016to 1 Jun 2019
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Allograft procured and transplanted into recipients.
Who may be able to join
- Men and women, Age 18-years old to 80-years old inclusive
- Valid TE with Fibroscan 402/530, defined as:
- At least 10 valid measurements
- IQR/Median stiffness value <30% (only in cases with >7.1 kPa)
Who cannot join
- Patient did not undergo liver transplantation
- Donation after circulatory death (DCD)
- No liver biopsy obtained during organ procurement process
Trial locations and contacts
3 sites in 1 country.
United States3 sites
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
Mayo Clinic
Rochester, Minnesota, 55905
Stanford University
Stanford, California, 94305
About this study
Official title: Usefulness of Controlled Attenuation Parameter (CAP) for the Assessment of Liver Steatosis in Liver Donors
The primary aim is to determine the accuracy of CAP in the quantification of liver steatosis using liver biopsies as reference. Secondarily, investigators will correlate transient elastography (TE) and CAP results, analyze possible associations between CAP/TE and post-liver transplant (LT) clinical outcomes, and evaluate the change in CAP after LT. The study aims to include as many donors as needed to achieve at least 120 transplanted liver allografts.
Read the detailed description
This is a coordinated study utilizing 3 recruitment centers (University of Arkansas for Medical Sciences [UAMS], Stanford University, and Mayo Clinic) 2 liver pathology reading centers (University of Michigan and Mayo Clinic), and 1 coordinating center (University of Arkansas). The cohort study with a cross-sectional component for the primary aim has been completed (through independent Institutional Review Board [IRB] agreements) at UAMS, Stanford University, and the Mayo Clinic. The samples collected at the three recruitment centers will be sent to the biopsy center at the University of Michigan and Mayo Clinic for evaluation. The Liver Transplant Program at each of the 3 recruiting centers will identify study subjects during the process of liver allocation to their listed recipients. Criteria for recruitment are as follows:
Inclusion criteria - Liver Recipient
- Men and women, Age 18-years old to 80-years old inclusive Inclusion criteria - Liver Donor
- Valid TE with Fibroscan 530, defined as:
- At least 10 valid measurements
- Interquartile Range (IQR)/Median stiffness value <30% (only in cases with >7.1 kPa) Exclusion criteria - Liver Recipient
- Patient did not undergo liver transplantation Exclusion criteria - Liver Donor
- Donation after circulatory death (DCD)
- No liver biopsy obtained during organ procurement process
- Conditions
- Liver Transplant, Liver Steatosis, Liver Disease, Primary Non-function, Early Allograft Dysfunction
- Being tested
- Fibroscan 402/530
- Medical subject headings
- Fatty Liver, Liver Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fibroscan 402/530Device
Fibroscan 402/530 obtained before procurement in the donor and at 1 to 3 months post-transplant in the liver recipient.
| Study group | Role | What they receive |
|---|---|---|
| CAP assessment | Controlled Attenuation Parameter with Fibroscan 402/530 before liver procurement and after liver transplantation to assess steatosis, and its association with clinical outcomes Receives: Device: Fibroscan 402/530 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Controlled Attenuation Parameter (CAP) - Accuracy
CAP accuracy in quantification of liver steatosis to be determined using liver biopsies as reference
Measured: Baseline (pre-procurement) to 6 months post liver transplant
Secondary outcomes (1)
LSM
Liver stiffness measurement
Measured: Pretransplant to 6 months posttransplant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2016 (estimated)
- Study start7 Sep 2016
- Primary completion1 Jun 2019
- Study completion1 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Liver TransplantStudies of the same condition, open and under way.
- 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
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Andres Duarte-Rojo
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Andres Duarte-Rojo, University of Pittsburgh
- Investigators
- Andres Duarte-Rojo, MD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02798861
- Sponsor's protocol ID
- 204560
- Status last verified
- Jul 2020
- First submitted
- 2 Jun 2016
- Last updated
- 31 Jul 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Usefulness of Controlled Attenuation Parameter (CAP) for the Assessment of Liver Steatosis in Liver Donors
- ClinicalTrials.gov ID
- NCT02798861
- Acronym / sponsor ID
- 204560
- Conditions
- Liver Transplant, Liver Steatosis, Liver Disease, Primary Non-function, Early Allograft Dysfunction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Andres Duarte-RojoUniversity, hospital or other
- Study start
- 7 Sep 2016 (actual)
- Primary completion
- 1 Jun 2019 (actual)
- Study completion
- 1 Jun 2019 (actual)
- First posted
- 14 Jun 2016 (estimated)
- Results
- Posted 31 Jul 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary aim is to determine the accuracy of CAP in the quantification of liver steatosis using liver biopsies as reference. Secondarily, investigators will correlate transient elastography (TE) and CAP results, analyze possible associations between CAP/TE and post-liver transplant (LT) clinical outcomes, and evaluate the change in CAP after LT. The study aims to include as many donors as needed to achieve at least 120 transplanted liver allografts.
Detailed description
This is a coordinated study utilizing 3 recruitment centers (University of Arkansas for Medical Sciences [UAMS], Stanford University, and Mayo Clinic) 2 liver pathology reading centers (University of Michigan and Mayo Clinic), and 1 coordinating center (University of Arkansas). The cohort study with a cross-sectional component for the primary aim has been completed (through independent Institutional Review Board [IRB] agreements) at UAMS, Stanford University, and the Mayo Clinic. The samples collected at the three recruitment centers will be sent to the biopsy center at the University of Michigan and Mayo Clinic for evaluation. The Liver Transplant Program at each of the 3 recruiting centers will identify study subjects during the process of liver allocation to their listed recipients. Criteria for recruitment are as follows:
Inclusion criteria - Liver Recipient
- Men and women, Age 18-years old to 80-years old inclusive Inclusion criteria - Liver Donor
- Valid TE with Fibroscan 530, defined as:
- At least 10 valid measurements
- Interquartile Range (IQR)/Median stiffness value <30% (only in cases with >7.1 kPa) Exclusion criteria - Liver Recipient
- Patient did not undergo liver transplantation Exclusion criteria - Liver Donor
- Donation after circulatory death (DCD)
- No liver biopsy obtained during organ procurement process
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CAP assessment | – | Device: Fibroscan 402/530Controlled Attenuation Parameter with Fibroscan 402/530 before liver procurement and after liver transplantation to assess steatosis, and its association with clinical outcomes |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Allograft procured and transplanted into recipients.
Key inclusion criteria (4 listed)
- Men and women, Age 18-years old to 80-years old inclusive
- Valid TE with Fibroscan 402/530, defined as:
Key exclusion criteria (3 listed)
- Patient did not undergo liver transplantation
- Donation after circulatory death (DCD)
- No liver biopsy obtained during organ procurement process
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 |
|---|---|---|
| Fibroscan 402/530Fibroscan 402/530 obtained before procurement in the donor and at 1 to 3 months post-transplant in the liver recipient. | Device | CAP assessment |
Primary outcome
Controlled Attenuation Parameter (CAP) - Accuracy
Time frame: Baseline (pre-procurement) to 6 months post liver transplant
CAP accuracy in quantification of liver steatosis to be determined using liver biopsies as reference
1 secondary outcome
LSM
Time frame: Pretransplant to 6 months posttransplant
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Andres Duarte-Rojo, MD principal investigator
University of Pittsburgh
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Transplant and Liver Steatosis, run by Andres Duarte-Rojo at 3 sites in United States.
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 4 inclusion and 3 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: finished, as of the sponsor's last update on 31 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. 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?
Yes. Results are posted in the registry (first posted 31 Jul 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Controlled Attenuation Parameter (CAP) - Accuracy (time frame: Baseline (pre-procurement) to 6 months post liver transplant). 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 31 Jul 2020.