A Study Of Senseera Liquid Biopsy In Detecting ACR

Overview

About this study

The purpose of the study is to optimize and validate the performance of the Senseera liquid biopsy cfChIP-seq assay for the detection of Acute Cellular Rejection (ACR) of the liver in patients who underwent a liver graft, as compared to the standard of care biopsy of the liver and histopathological examination by specialized pathologists.

The sensitivity and specificity of the test will be compared to the reference standard, based on the biopsy results, and the overall diagnostic accuracy of the assay will be assessed.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Male or female aged 18 years or older.

  • Subject is able to provide written informed consent and agree to provide access to their de-identified clinical data for the study.

  • Subject underwent documented liver transplantation.

  • Subject is scheduled for a for-cause liver biopsy as determined by their physician’s clinical assessment of potential risk of liver transplant rejection.

  • Subject is able have a blood sample drawn within 24 hours prior to the biopsy.

 

Exclusion Criteria:

  • Subject is receiving treatment for acute liver rejection prior to giving blood sample and undergoing biopsy.

  • Subject is currently participating in another clinical trial involving investigational or marketed products that may interfere with study results.

  • Subject has a history of multiple organ transplantation (such as combined liver-kidney transplants).

  • Subject was diagnosed with chronic rejection or a condition that may not provide meaningful biopsy results (e.g., severe fibrosis or cirrhosis unrelated to rejection).

  • Subject has a known diagnosis of conditions that could compromise study results, such as active malignancies, untreated infections, or significant hemodynamic instability.

  • Subject is suffering of any condition that, in the opinion of the Principal Investigator, could increase the participant’s risk or compromise the quality of the study data.

  • Pregnant and breastfeeding individuals will be excluded. Post-parturient subjects will be excluded for one month after delivery.

  • Recipients of blood transfusions within 1 day prior to blood sampling for this study.

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 5/20/2025. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Jacksonville, Fla.

Mayo Clinic principal investigator

Liu Yang

Contact us for the latest status

Contact information:

Clinical Studies Unit

(904) 953-2255

More information

Publications

Publications are currently not available