Metagenomics Next-generation Sequencing Approach to Detect Microbial DNA/RNA Overtime in Individuals Undergoing Hematopoietic Stem Cell Transplant

Phase

N/A

Condition

Bone Marrow Transplant

Anemia

Treatment

N/A

Clinical Study ID

NCT06904053

10001923

001923-CC

Ages 3-100
All Genders

Study Summary

Infections are a major cause of morbidity and mortality in patients undergoing hematopoietic stem cell transplant (HSCT). The purpose of this study is to evaluate if metagenomic next-generation sequencing (mNGS) can detect microbial signatures in people undergoing HSCT, and if microbial identification can be correlated with clinical features of infection (e.g., fever). Participants undergoing HSCT as part of other studies at the NIH Clinical Center (CC) will provide blood before the transplant and through 6 months after. Total nucleic acid will be extracted from plasma and subjected to mNGS.

The primary objective of this study is to investigate if by using plasma and an mNGS approach, we can detect bacterial, fungal, protozoan, or viral DNA/RNA over time, in immunocompromised patients undergoing transplantation.

Secondary objectives are to: (1) To correlate microbial identification with episodes of fever or clinical suspicion of infection; and to (2) correlate change in microbial signatures in patients with suspected immune reconstitution inflammatory syndrome.

The study is conducted at the NIH Clinical Center. Participants, aged 3 years and older, on other research studies at the NIH CC who are undergoing HSCT are invited to take part of this study. Expected participation is up to six months.

Eligibility Criteria

Inclusion

INCLUSION CRITERIA:

In order to be eligible to participate in this study; an individual must meet all the following criteria:

Male or female, aged 3 years or older.
Co-enrolled on another study at the NIH CC, under which they will undergo HSCT.
Stated willingness to comply with all study procedures and availability for theduration of the study.
Ability of subject or Legally Authorized Representative (LAR) to understand and thewillingness to sign a written informed consent document.

Exclusion

EXCLUSION CRITERIA:

An individual with any condition that, in the opinion of the investigator, contraindicates participation in this study, will be excluded.

Study Design

April 09, 2025

December 30, 2030

Study Description

Study Description:

Participants undergoing HSCT as part of other studies at the NIH Clinical Center (CC) will provide blood before the transplant and through 6 months after. Total nucleic acid will be extracted from plasma and subjected to mNGS.

Objectives:

Primary:

To investigate if by using plasma and an mNGS approach, we can detect bacterial, fungal, protozoan, or viral DNA/RNA over time, in immunocompromised patients undergoing transplantation.

Secondary:

To correlate microbial identification with episodes of fever or clinical suspicion of infection.
To correlate change in microbial signatures in patients with suspected immune reconstitution inflammatory syndrome.

Endpoints: