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Molecular Assessment and Profiling of Liver Transplant Recipients (MAPLE)

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ClinicalTrials.gov Identifier: NCT04793360
Recruitment Status : Recruiting
First Posted : March 11, 2021
Last Update Posted : August 30, 2022
Information provided by (Responsible Party):

Brief Summary:
The objective of this protocol is to conduct longitudinal and prospective studies of liver transplant recipients, using a multimodality approach, akin to that used in kidney transplantation. The primary aim will compare the clinical outcomes of LiverCare post-transplant surveillance in liver transplant with standard of care consisting of liver function tests, DSA measurements, drug level monitoring, and 'for cause' biopsy. The protocol will assess the correlation between clinical events (e.g. rejection, recurrent disease, biliary obstruction), dd-cfDNA levels, gene expression profiling, ability to assess microchimerism, develop predictive analytics, infectious disease diagnoses and finally examine graft histology.

Condition or disease Intervention/treatment
Liver Transplantation Biomarkers Device: LiverCare

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Study Type : Observational
Estimated Enrollment : 1500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Molecular Assessment and Profiling of Liver Transplant Recipients
Actual Study Start Date : May 26, 2021
Estimated Primary Completion Date : December 31, 2025
Estimated Study Completion Date : December 31, 2025

Resource links provided by the National Library of Medicine

Group/Cohort Intervention/treatment
LiverCare Surveillance
Participants undergoing orthotopic liver transplant (de-novo or re-transplant) will be considered for this study
Device: LiverCare
The LiverCare kits contains Streck tubes and PAX gene tubes, which will be collected at the surveillance schedule outlined above, but also prior to any liver biopsy or DSA measurement. For patients who have a histological diagnosis of allograft rejection who are undergoing treatment, serial monitoring of LiverCare will be performed following the schedule above. All research blood tests will be timed with standard clinical testing to avoid any additional needle sticks.

Primary Outcome Measures :
  1. To correlate the results of LiverCare with clinically significant events impacting post-transplant clinical outcomes, histological findings, and the development of de novo Donor Specific Antibody (DSA) [ Time Frame: 2 years of accrual and 3 years follow up ]
    LiverCare will be measured 7 times in year 1 and quarterly each year. A total of 15 surveillance points per subject in addition to for-cause testing based on clinical changes. Liver care will be collected at the time of all histologic analyses whether 'for cause' or 'surveillance'

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
All liver transplant patients without exclusion criteria will be eligible to enter the study. Patients will be approached by the study team at the time of transplant or within 60 days post-transplant to discuss the trial, consent and enrollment.

Inclusion Criteria:

  • Liver transplant recipients <60 days post-transplant (de-novo or re-transplant).
  • Participant is willing and able to give informed consent for participation in the trial.
  • Male or Female, aged 12 years or above (Gillick Competent).
  • In the Investigator's opinion, is able and willing to comply with all trial requirements.

Exclusion Criteria:

  • Female participant who is pregnant, lactating or planning pregnancy during the course of the trial.
  • Has evidence of significant post-transplant impairment of hepatic function which is unlikely to improve (determined by the PI).
  • Scheduled elective surgery or other procedures requiring general anaesthesia during the trial.
  • Participant with life expectancy of less than 6 months or is inappropriate for diagnostic monitoring through regular blood sampling.
  • Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial.
  • Participants who have participated in another research trial involving an investigational product in the past 12 weeks*.
  • Multi-organ transplant recipients or dual organ transplant recipients.
  • Patients with significant needle phobia.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04793360

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Contact: Jake Miles, M.D. (929) 363-5937 jmiles@caredx.com

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Sponsors and Collaborators
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Study Chair: Jake Miles, M.D. CareDx
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Responsible Party: CareDx
ClinicalTrials.gov Identifier: NCT04793360    
Other Study ID Numbers: SN-C-00015
First Posted: March 11, 2021    Key Record Dates
Last Update Posted: August 30, 2022
Last Verified: August 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No