NCT05050955

AlloSure Lung Assessment and Metagenomics Outcomes Study

Study Contact:

Brandie Casassa - Role: CONTACT - Phone: 415-287-2300 - Email: bcasassa@caredx.com
Srey Yin - Role: CONTACT - Phone: 415-287-2300 - Email: syin@caredx.com

Study Phase:

Recruitment Status:

RECRUITING

NCT ID:

NCT05050955

Principal Investigator:

Study Type:

OBSERVATIONAL

Official Title:

AlloSure Lung Assessment and Metagenomics Outcomes Study

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).

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

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

Disease(s) and\or Condition(s)

Lung Transplant Infection

Lung Transplant; Complications

Lung Transplant Failure and Rejection

Primary Purpose

Intervention/Treatment

Sponsor

CareDx