Massively Parallel Sequencing to Identify Microbiological Organisms in Bronchoalveolar Lavage Fluid

NCT03995030 | Completed

• 1 other identifier: NYMC 181
• Study Type: observational
• Target: 10
• Locations: 0 countries
• Sites: N/A

Brief Summary

Patients who are post hematopoietic stem cell transplantation who require a bronchoalveolar lavage (BAL) for standard clinical car will have extra fluid collected and sent for massively parallel sequencing to see if it is as sensitive for detecting a microbial pulmonary infection compared to standard cultures.

Conditions

Pulmonary Infection

Outcome Measures

Primary Outcomes (1)

• Percentage concordance between massively paralleled sequencing (MPS) and standard microbiological technique results.

  Children, adolescents and young adult (CAYA) hematopoietic stem cell transplantation (HSCT) subjects with clinical symptoms/indications will undergo bronchoalveolar lavage (BAL), with samples from those with sufficient BAL fluid yield (\>10ml) undergoing both massively paralleled sequencing and standard microbiological technique comparison.

  10 days

Interventions

massively paralleled sequencing DIAGNOSTIC_TEST

Whole genome sequencing libraries will be generated and sequenced in batches on the Illumina MiSeq. FASTQ files will be demultiplexed and then aligned to microbial genomes using Phylosift.

Eligibility Criteria

• Age: 0 Years - 29 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Patients less than 30 years old who have had a hematopoietic stem cell transplantation and require a BAL for clinical diagnosis.

You may qualify if:

• Patient age \< 30 years
• Recipient of an autologous or allogeneic stem cell transplant in the previous 365 days
• Requires a bronchoalveolar lavage for clinical indications

You may not qualify if:

• Lack of signed informed consent

Sponsors & Collaborators

• New York Medical College: lead

Biospecimen

Retention: SAMPLES WITH DNA

Extra BAL fluids will be sent to for massively parallel sequencing research tests at New York Medical College Genomics Core Facility. The research portion will be further divided for isolation of viral, bacterial, and fungal nucleic acid isolation. A control sample of fluid used for the BAL will be prepared in parallel. Bacterial/fungal DNA and viral DNA and RNA will be isolated. Whole genome sequencing libraries will be generated and sequenced in batches on the Illumina MiSeq.

Study Officials

• Jeremy Rosenblum, MD

  New York Medical College

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2019
• First Posted: June 21, 2019
• Study Start: September 15, 2016
• Primary Completion: January 31, 2019
• Study Completion: December 31, 2021
• Last Updated: October 25, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: submit for publication Q4 2019