Liver Transplant RejectionTOGETHERNCT03874286
The TOGETHER Project - Liver
An observational study of Liver Transplant Rejection, run by Mayo Clinic at 3 sites in United States.
Trial summary
To validate the use of a RNAseq-based peripheral blood assay in liver transplant recipients when correlated to liver biopsy results. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Transplant Rejection
- What is being tested?
- Liver Transplant
- How many people
- 54 participants
- Where
- 3 sitesUnited States
- Study dates
- 15 Mar 2017to 30 Apr 2020
- 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: Adult liver transplant recipients with diverse demographics (e.g. recipient race and donor type) and treatment strategies (induction, steroid-free, etc.).
Who may be able to join
- Patients who have given informed consent and are willing to comply with the protocol, including the use of their peripheral blood specimens and data for subsequent research.
- Patients with increased risk of rejection. Patients must meet at least one of the following criteria:
- Autoimmune etiology of the original liver disease (autoimmune hepatitis, primary biliary cirrhosis or primary sclerosing cholangitis)
- Recipients of donation-after-cardiac death (DCD) donors
- Recipients of simultaneous liver-kidney transplantation
- Positive crossmatch liver transplant (T cell flow crossmatch or B cell flow crossmatch).
Who cannot join
- Adult ( ≥ = 18 years) renal transplant recipient.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Mayo Clinic
Jacksonville, Florida, 32224
Mayo Clinic
Phoenix, Arizona, 85054
Mayo Clinic
Rochester, Minnesota, 55905
About this study
Official title: The Together Project-Transplant Organ Genomics to Help Prevent Rejection in Liver Transplant Recipients
To validate the use of a RNAseq-based peripheral blood assay in liver transplant recipients when correlated to liver biopsy results.
Read the detailed description
The study is a prospective, observational study utilizing peripheral blood assays that will be collected at time points that are considered standard of care at most institutions. 100 participants will be enrolled in study. Participants will have peripheral blood collected at 4 months and 12 months after liver transplant, as well as any for cause time points. Participants will also have liver biopsies collected at these time points. The results from the liver biopsies will be used in correlation with the results from the peripheral blood assays.
- Conditions
- Liver Transplant Rejection
- Being tested
- Liver Transplant
- Keywords
- Liver Transplant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liver TransplantDiagnostic test
Also called Liver biopsy
Patients will obtain a research blood draw and a liver biopsy at 4 months and 12 months post transplant. Liver biopsies are routinely performed in the liver transplant population. We will be obtaining a liver biopsy at this particular time point to compare the biopsy results with the peripheral blood results.
| Study group | Role | What they receive |
|---|---|---|
| Liver Transplant | Participants will obtain a liver biopsy at 4 months post transplant and 12 months post transplant. Receives: Diagnostic Test: Liver Transplant |
What is being measured
The primary outcome is the main question the study is designed to answer.
To validate the use of a RNAseq-based peripheral blood assay in liver transplant recipients when correlated to liver biopsy results.
The primary endpoint for this study is defined as obtaining the results of the RNAseq testing and to determine if an assay for rejection can be developed.
Measured: 3 years
Secondary outcomes (1)
To validate the use of a RNAseq-based peripheral blood assay in liver transplant recipients when correlated to liver biopsy results.
The secondary endpoint for this study is defined as obtaining the results of the RNAseq testing and to ascertain whether an assay for detection of disease recurrence can be developed.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2019
- Study start15 Mar 2017
- Primary completion30 Apr 2020
- Study completion30 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver Transplant RejectionStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mark Stegall, Mayo Clinic
- Investigators
- Mark Stegall, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03874286
- Sponsor's protocol ID
- IRB# 16-006453
- Acronym
- TOGETHER
- Status last verified
- May 2022
- First submitted
- 12 Mar 2019
- Last updated
- 20 May 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 20 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Together Project-Transplant Organ Genomics to Help Prevent Rejection in Liver Transplant Recipients
- ClinicalTrials.gov ID
- NCT03874286
- Acronym / sponsor ID
- TOGETHER / IRB# 16-006453
- Conditions
- Liver Transplant Rejection
- Keywords
- Liver Transplant
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 15 Mar 2017 (actual)
- Primary completion
- 30 Apr 2020 (actual)
- Study completion
- 30 Apr 2020 (actual)
- First posted
- 14 Mar 2019 (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.
To validate the use of a RNAseq-based peripheral blood assay in liver transplant recipients when correlated to liver biopsy results.
Detailed description
The study is a prospective, observational study utilizing peripheral blood assays that will be collected at time points that are considered standard of care at most institutions. 100 participants will be enrolled in study. Participants will have peripheral blood collected at 4 months and 12 months after liver transplant, as well as any for cause time points. Participants will also have liver biopsies collected at these time points. The results from the liver biopsies will be used in correlation with the results from the peripheral blood assays.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Liver Transplant | – | Diagnostic Test: Liver TransplantParticipants will obtain a liver biopsy at 4 months post transplant and 12 months post transplant. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult liver transplant recipients with diverse demographics (e.g. recipient race and donor type) and treatment strategies (induction, steroid-free, etc.).
Key inclusion criteria (6 listed)
- Patients who have given informed consent and are willing to comply with the protocol, including the use of their peripheral blood specimens and data for subsequent research.
- Patients with increased risk of rejection. Patients must meet at least one of the following criteria:
Key exclusion criteria (1 listed)
- Adult ( ≥ = 18 years) renal transplant recipient.
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 TransplantAlso: Liver biopsyPatients will obtain a research blood draw and a liver biopsy at 4 months and 12 months post transplant. Liver biopsies are routinely performed in the liver transplant population. We will be obtaining a liver biopsy at this particular time point to compare the biopsy results with the peripheral blood results. | Diagnostic test | Liver Transplant |
Primary outcome
To validate the use of a RNAseq-based peripheral blood assay in liver transplant recipients when correlated to liver biopsy results.
Time frame: 3 years
The primary endpoint for this study is defined as obtaining the results of the RNAseq testing and to determine if an assay for rejection can be developed.
1 secondary outcome
To validate the use of a RNAseq-based peripheral blood assay in liver transplant recipients when correlated to liver biopsy results.
Time frame: 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2022.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- 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.
Mark Stegall, MD principal investigator
Mayo Clinic
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 Rejection, run by Mayo Clinic 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 6 inclusion and 1 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 20 May 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
To validate the use of a RNAseq-based peripheral blood assay in liver transplant recipients when correlated to liver biopsy results. (time frame: 3 years). 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 20 May 2022.