ACTIVE_NOT_RECRUITING

AlloSure Lung Assessment and Metagenomics Outcomes Study

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official Title

AlloSure Lung Assessment and Metagenomics Outcomes Study

Quick Facts

Study Start:2021-10-29
Study Completion:2028-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05050955

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Unilateral or Bilateral, deceased-donor, initial or re-transplant
  2. 2. ≤ 90 days post-transplant
  3. 3. Ability to understand and provide informed consent and adhere to laboratory surveillance schedule
  4. 4. Patients who have LungCare initiated within 30 days of signing the informed consent form
  1. 1. Multi-organ transplants
  2. 2. Pregnancy
  3. 3. Active malignancy

Contacts and Locations

Principal Investigator

Debbie Levine
PRINCIPAL_INVESTIGATOR
Stanford University
Nirmal Sharma
PRINCIPAL_INVESTIGATOR
Brigham and Women's Hospital

Study Locations (Sites)

University of Alabama (UAB)
Birmingham, Alabama, 35233
United States
St. Joseph's Hospital & Medical Center
Phoenix, Arizona, 85013
United States
Cedars Sinai Medical Center
Los Angeles, California, 90048
United States
University of California (UCSF) School of Medicine
San Francisco, California, 94143
United States
University of CO Anschutz Medical Campus
Aurora, Colorado, 80045
United States
AdventHealth Orlando
Orlando, Florida, 32804
United States
Loyola University Medical School
Maywood, Illinois, 60153
United States
University of Louisville Health
Louisville, Kentucky, 40202
United States
University of Mayland
Baltimore, Maryland, 21201
United States
Brigham and Womens Hospital
Boston, Massachusetts, 02115
United States
Washington University-Barnes Jewish Hospital
St Louis, Missouri, 63110
United States
NYU Langone Health
New York, New York, 10016
United States
Columbia University Medical Center
New York, New York, 10027
United States
Montefiore Medical Center
The Bronx, New York, 10467
United States
Ohio State University
Columbus, Ohio, 43210
United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
United States
Temple University
Philadelphia, Pennsylvania, 19140
United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
United States
UT Health/ Memorial Hermann Hospital
Houston, Texas, 77030
United States
Inova
Falls Church, Virginia, 22042
United States
University of Wisconsin Madison
Madison, Wisconsin, 53792
United States

Collaborators and Investigators

Sponsor: CareDx

  • Debbie Levine, PRINCIPAL_INVESTIGATOR, Stanford University
  • Nirmal Sharma, PRINCIPAL_INVESTIGATOR, Brigham and Women's Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-10-29
Study Completion Date2028-12-31

Study Record Updates

Study Start Date2021-10-29
Study Completion Date2028-12-31

Terms related to this study

Additional Relevant MeSH Terms

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