RECRUITING

Non-Invasive Diagnosis of Pediatric Pulmonary Invasive Mold Infections

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Conditions

Pulmonary Invasive Fungal InfectionsPulmonary Invasive Aspergillosis

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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

This study will establish a non-invasive diagnostic approach and evaluate clinical outcomes for children at high-risk for pulmonary invasive fungal infection (PIFI).

Official Title

Non-Invasive Diagnosis of Pediatric Pulmonary Invasive Mold Infections

Quick Facts

Study Start:2018-10-30
Study Completion:2026-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03827694

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:120 Days to 21 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. * Males or females age \> 120 days and \< 22 years at any participating site
  2. * Have at least one of the following conditions associated with a known high incidence of IFI: hematopoietic stem cell transplantation (HSCT), aplastic anemia, bone marrow failure, primary or acquired immune deficiency, or malignancy
  3. * New (last 96 hours) radiographic evidence of at least one of the following: at least one nodular lesion greater than or equal to 5 mm in size, a wedge-shaped and segmental or lobar consolidation, a cavitary lesion, a lesion with a halo sign, a lesion with a reverse halo sign, or a lesion with an air crescent sign
  4. * Prolonged neutropenia (absolute neutrophil count \< 500 cells/µl for a period of ≥ 5 consecutive days) in 30 days prior to and including the day of qualifying chest MRI or CT scan date OR currently receiving systemic therapy for acute or chronic graft-versus-host disease (GVHD) OR presence of neutrophil dysfunction because of underlying acquired or primary immune deficiency (e.g. chronic granulomatous disease) on the date of the qualifying chest MRI or CT scan
  5. * Subject consent or parental/guardian permission (informed consent) and if appropriate, child assent
  1. * Weight \<3 kg, so as to not exceed 3 ml/kg in a single blood draw
  2. * Previous inclusion in this study

Contacts and Locations

Study Contact

PFN Central Coordinator
CONTACT
501-364-3057
PFNClinical@uams.edu

Principal Investigator

William Steinbach
PRINCIPAL_INVESTIGATOR
University of Arkansas
Brian Fisher
PRINCIPAL_INVESTIGATOR
Children's Hospital of Philadelphia

Study Locations (Sites)

Arkansas Children's Research Institute
Little Rock, Arkansas, 72202
United States
Rady Children's Hospital, UCSD
La Jolla, California, 92093
United States
Children's Hospital of Orange County
Orange, California, 92868
United States
Lucile Packard Children's Hospital, Stanford University
Palo Alto, California, 94305
United States
University of California San Francisco, Benioff Children's Hospital
San Francisco, California, 94143
United States
Yale University
New Haven, Connecticut, 06520
United States
Children's National Hospital
Washington, District of Columbia, 20010-2916
United States
All Children's Research Institute
Saint Petersburg, Florida, 33701
United States
Emory University-Children's Healthcare of Atlanta (CHOA)
Atlanta, Georgia, 30322
United States
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611
United States
University of Chicago Medicine, Comer Children's
Chicago, Illinois, 60637
United States
Indiana University School of Medicine
Indianapolis, Indiana, 46202
United States
Boston Children's Hospital
Boston, Massachusetts, 02241
United States
University of Minnesota Medical School
Minneapolis, Minnesota, 55455
United States
Children's Minnesota
Saint Paul, Minnesota, 55102
United States
Children's Mercy
Kansas City, Missouri, 64108
United States
The Washington University
Saint Louis, Missouri, 63110
United States
Children's Omaha
Omaha, Nebraska, 68114
United States
Weil Cornell Medical College
New York, New York, 10021
United States
Duke University Medical Center
Durham, North Carolina, 27710
United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
United States
Cleveland Clinic
Cleveland, Ohio, 44195
United States
Nationwide Children's Hospital
Columbus, Ohio, 43205-2664
United States
Oregon Health and Science University
Portland, Oregon, 97239
United States
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19146
United States
St. Jude Children's Research Hospital
Memphis, Tennessee, 38105
United States
Monroe Carell Jr. Children's Hospital at Vanderbilt
Nashville, Tennessee, 37232
United States
Ascension Seton Medical Center
Austin, Texas, 78705
United States
University of Texas Southwest Medical Center (UTSW)
Dallas, Texas, 75390
United States
MD Anderson
Houston, Texas, 77030
United States
Seattle Children's Research Institute
Seattle, Washington, 98105
United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
United States

Collaborators and Investigators

Sponsor: Arkansas Children's Hospital Research Institute

  • William Steinbach, PRINCIPAL_INVESTIGATOR, University of Arkansas
  • Brian Fisher, PRINCIPAL_INVESTIGATOR, Children's Hospital of Philadelphia

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 Date2018-10-30
Study Completion Date2026-12-31

Study Record Updates

Study Start Date2018-10-30
Study Completion Date2026-12-31

Terms related to this study

Additional Relevant MeSH Terms

  • Pulmonary Invasive Fungal Infections
  • Pulmonary Invasive Aspergillosis