Summary

Eligibility
for people ages 18 years and up (full criteria)
Healthy Volunteers
healthy people welcome
Location
at UCSF
Dates
study started
completion around
Principal Investigator
by Steven Hays (ucsf)
Headshot of Steven Hays
Steven Hays

Description

Summary

ALAMO is a prospective, multi-center, perspective, registry of patients receiving LungCare™ (AlloSure®-Lung, AlloMap Lung, and HistoMap) for surveillance post-transplant. This study aims to evaluate the diagnostic performance characteristics of AlloSure Lung (dd-cfDNA) to detect a spectrum of rejection (ACR, AMR) and allograft infection (Bacterial, Viral, Fungal, Mycobacterial, Parasitic).

Details

This is a prospective, multicenter, observational registry of lung transplant recipients receiving LungCare (AlloSure-Lung, AlloMap Lung, and Histomap) surveillance testing. Patients will be recruited based on utilization of surveillance testing with LungCare, as deemed appropriate for their care post-transplant. Patients deemed eligible for the study by their physician will be invited to participate during their usual care visit. Enrolled patients will receive evaluations and treatment for their lung transplant according to their health care provider and clinical practice at each study site. Treatment and follow-up visits will be determined by the treating physician. Information related to surveillance testing, selected clinical outcomes, and treatments received for managing the lung transplant recipients will be collected from medical records. The product Laboratory Services Guide(s) will be provided as a reference. Patient data (including diagnosis and biopsy outcomes) will be drawn from the patients' medical records. This data will be recorded by the site study personnel via a web-based electronic data collection (EDC) system every month.

The study is designed to observe the clinical use of LungCare and patient outcomes in a cohort of lung transplant recipients managed with LungCare. This cohort design is selected because it is efficient and effective to evaluate the real-world robust performance of LungCare on patient management and outcomes that can be generalized to the intended use population. A well-designed observational cohort study that includes a large number of patients with long-term follow-up may provide robust results with several advantages, such as gathering data regarding sequence of events to assess causality; examining multiple outcomes for a given LungCare use; calculating rates of biopsy and rejection; and operational efficiency.

Keywords

Lung Transplant Infection, Lung Transplant; Complications, Lung Transplant Failure and Rejection

Eligibility

You can join if…

Open to people ages 18 years and up

  1. Unilateral or Bilateral, deceased-donor, initial or re-transplant
  2. ≤ 90 days post-transplant
  3. Ability to understand and provide informed consent and adhere to laboratory surveillance schedule
  4. Patients who have LungCare initiated within 30 days of signing the informed consent form

You CAN'T join if...

  1. Multi-organ transplants
  2. Pregnancy
  3. Active malignancy

Locations

  • University of California (UCSF) School of Medicine accepting new patients
    San Francisco California 94143 United States
  • Cedars Sinai Medical Center accepting new patients
    Los Angeles California 90048 United States

Lead Scientist at University of California Health

  • Steven Hays (ucsf)
    Dr. Steven Hays, a pulmonologist, is medical director of the UCSF Lung Transplant Program, which is known for accepting patients with complex conditions while maintaining superior survival rates. His expertise is in caring for patients with end-stage lung disease who proceed through the lung transplant process.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
CareDx
ID
NCT05050955
Study Type
Observational [Patient Registry]
Participants
Expecting 500 study participants
Last Updated