Clinical trial NCT06904053: Metagenomics Next-generation Sequencing Approach to Detect Microbial DNA/RNA Overtime in Individuals Undergoing Hematopoietic Stem Cell Transplant
Official title: Metagenomics Next-Generation Sequencing Approach to Detect Microbial DNA/RNA Overtime in Individuals Undergoing Hematopoietic Stem Cell Transplant
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hematopoietic Stem Cell Transplantation
Keywords: Microbial DNA/RNA
Hematopoietic stem cell transplant (HSCT)
Lead sponsor: National Institutes of Health Clinical Center (CC)
Sponsor class: NIH
First posted: 2025-04-01
Enrollment: 30
Sex: ALL
Minimum age (years): 3
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Participants aged 3 years and older on other research studies at the NIH CC who are undergoing HSCT as part of that study.

Brief 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.

Detailed description: Study Description:

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.

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:

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

Endpoints:

Primary:

Comparison of mNGS results to routine clinical test results (microbiology and/or pathology)

Secondary:

1. Calculation of frequencies of different microbial identifications as it relates to the development of fever or microbiologically/clinically defined infection.
2. Changes in different microbial signatures over time

Eligibility criteria: * INCLUSION CRITERIA:

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

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

EXCLUSION CRITERIA:

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

Primary outcomes:
measure: Any positive clinical results for each of 5 pathogen categories
timeFrame: Six months
Secondary outcomes:
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: National Institutes of Health Clinical Center
state: Maryland
Study officials:
affiliation: National Institutes of Health Clinical Center (CC)
name: Sanchita Das, M.D.
role: PRINCIPAL_INVESTIGATOR
References: