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

Status: Recruiting
Location: See location...
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 3
Maximum Age: 100
Healthy Volunteers: f
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⁃ 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 the duration of the study.

• Ability of subject or Legally Authorized Representative (LAR) to understand and the willingness to sign a written informed consent document.

Locations
United States
Maryland
National Institutes of Health Clinical Center
RECRUITING
Bethesda
Contact Information
Primary
Mary M Czech, M.D.
mary.czech@nih.gov
(240) 447-9109
Backup
Sanchita Das, M.D.
sanchita.das@nih.gov
(301) 496-5668
Time Frame
Start Date: 2025-04-09
Estimated Completion Date: 2030-12-30
Participants
Target number of participants: 30
Treatments
All HSCT patients
Male or female, aged 3 years or older.
Related Therapeutic Areas
Sponsors
Leads: National Institutes of Health Clinical Center (CC)

This content was sourced from clinicaltrials.gov