Actively Recruiting

Age: 3Years - 100Years
All Genders
NCT06904053

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

Led by National Institutes of Health Clinical Center (CC) · Updated on 2026-04-06

30

Participants Needed

1

Research Sites

298 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 3Years - 100Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Male or female aged 3 years or older
  • Co-enrolled on another study at the NIH Clinical Center undergoing HSCT
  • Willingness to comply with all study procedures and be available for the study duration
  • Ability of the participant or legally authorized representative to understand and sign informed consent
Not Eligible

You will not qualify if you...

  • Any condition that the investigator believes contraindicates participation in the study

AI-Screening

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Trial Site Locations

Total: 1 location

1

National Institutes of Health Clinical Center

Bethesda, Maryland, United States, 20892

Actively Recruiting

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Research Team

M

Mary M Czech, M.D.

CONTACT

S

Sanchita Das, M.D.

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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