Recruiting

Observational Study

Sponsor:

Pediatric Blood and Marrow Transplant Foundation, Inc.

Code:

NCT02926612

Conditions

Lower Respiratory Tract Infections

Eligibility Criteria

Sex: All

Age: 0 - 21

Healthy Volunteers: Not accepted

Interventions

Next Generation Genomic Sequencing

Study Details

Brief summary:

This is a multicenter prospective collection of leftover respiratory tract secretions, paired blood and NP swabs, and clinical circumstances from pediatric HCT patients, followed by next generation genomic sequencing, transcriptome analysis, protein biomarker measurement, and statistical modeling.

Conditions

Lower Respiratory Tract Infections

Study ID

NCT02926612

Start date

Jun, 2016

Status verified date

Aug, 2018

Primary completion date

Dec, 2019

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 21

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Patients will be ≤21 years of age with a history of HCT of any type at any point in the past, and are planned to undergo clinically-indicated collection of any lower respiratory specimen, including but not limited to bronchoalveolar lavage (either via a plugged telescoping catheter such as a CombiCath, or with fiberoptic bronchoscopy) and tracheal aspirate.
  • For the purposes of this study, induced or spontaneous sputum is not considered a lower respiratory tract specimen.
  • Patients may have any underlying indication for clinical testing of lower respiratory secretions, including but not limited to suspected infection, non-infectious inflammation, obstructive or restrictive lung disease, pulmonary edema, pleural effusions, alveolar hemorrhage, aspiration, or pulmonary vascular disease.
  • Patients who have not undergone HCT but plan to undergo HCT in the future, hereafter referred to as pre-HCT patients, may also be enrolled.
  • Pre-HCT patients must have intention to undergo stem cell transplantation in the future and include but are not limited to patients with primary immunodeficiency, patients with malignancy undergoing induction or consolidation chemotherapy, and HCT patients with selected cell sources who are undergoing pre-transplant conditioning but have not yet received their cellular infusion.

Exclusion Criteria:

  • Patients will not be >21 years of age.
  • Patients who do not have a clinical indication for obtaining lower respiratory secretions for testing as part of their direct patient care will be excluded.
  • Patients who do not have sufficient respiratory secretions remaining after collection and aliquoting for indicated clinical tests ordered by the treating clinician will also be excluded.
  • Patients who undergo lower respiratory testing solely to evaluate for relapsed malignancy will be excluded.

Study Design

Enrollment

250 participants

Anticipated

Interventions and Outcome Measures

Arms

HCT recipients ages ≤21 years

HCT recipients ages ≤21 years for whom lower respiratory secretions are being collected for direct patient care.

Interventions

Next Generation Genomic Sequencing

DNA and RNA are extracted from biospecimens, amplified, sequenced, and then compared to known microbe databases, allowing for quantitative identification of non-host organisms

Primary outcome measure

  • Evaluate and quantify the utility of NGS in improving the diagnosis of LRTI in pediatric HCT patients. [ Time Frame: 3 years ]

Central Contacts and Locations

Central contacts

Matthew Zinter, MD

415-683-9666matt.zinter@ucsf.edu

Locations

University of California, San Francisco

Recruiting

San Francisco, California, United States, 94143

Contacts

Matt S. Zinter, MD

415-683-9666matt.zinter@ucsf.edu

Kevin Magruder

415-476-3834kevin.magruder@ucsf.edu

More Information

Sponsor

Pediatric Blood and Marrow Transplant Foundation, Inc.

Last update posted

Aug 31, 2018

Last verified

Aug, 2018

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Pediatric Blood and Marrow Transplant Foundation, Inc. on 2018-08-31.