Pathogen Identification in Pediatric Hematopoietic Stem C... | NCT02926612

Status Module

Record Verification Date

Aug 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2016

Primary Completion Date

Dec 2019Estimated

Completion Date

Not provided

First Submitted Date

Oct 4, 2016

First Submission Date that Met QC Criteria

Oct 4, 2016

First Posted Date

Oct 6, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 29, 2018

Last Update Posted Date

Aug 31, 2018Actual

Name	Class
St. Baldrick's Foundation	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

This study is a multicenter cross-sectional observational analysis of unused lower respiratory tract secretions collected from children with a history of HCT who are undergoing evaluation for pulmonary complications. Patients will be screened and enrolled by study coordinators at each site, who will collect and submit biospecimens as well as patient characteristics and clinical outcomes. Metagenomic NGS will be performed on these biospecimens in an attempt to identify microbial pathogens and markers of host response to infection, including immune activation, inflammation, and cell damage. This study will then correlate these results with patient characteristics, clinical microbiology test results, and clinical outcomes in order to evaluate the utility of metagenomics NGS in improving the diagnosis of LRTI in our pediatric HCT population.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

250Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
HCT recipients ages ≤21 years		HCT recipients ages ≤21 years for whom lower respiratory secretions are being collected for direct patient care.	Other: Next Generation Genomic Sequencing

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Next Generation Genomic Sequencing	Other	DNA and RNA are extracted from biospecimens, amplified, sequenced, and then compared to known microbe databases, allowing for quantitative identification of non-host organisms

Measure	Description	Time Frame
Evaluate and quantify the utility of NGS in improving the diagnosis of LRTI in pediatric HCT patients.		3 years

Measure	Description	Time Frame
Evaluate the utility of human gene expression profiling in improving our understanding of host-microbe interactions in infectious and alloreactive pulmonary inflammation.		3 years

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

21 Years

Standard Ages

ChildAdult

Study Population

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

Sampling Method

Non-Probability Sample

Name	Role	Phone	Extension	Email
Matthew Zinter, MD	Contact	415-683-9666		matt.zinter@ucsf.edu

Name	Affiliation	Role
Matthew Zinter, MD	University of California, San Francisco	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
University of California, San Francisco	Recruiting	San Francisco	California	94143	United States

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Individual patient results will be available to the patient site, but it is undecided whether or not to make these results available to everyone.

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided