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

Launched by NATIONAL INSTITUTES OF HEALTH CLINICAL CENTER (CC) · Mar 29, 2025

Keywords

ClinConnect Summary

This clinical trial is studying how a new technique called metagenomic next-generation sequencing (mNGS) can help identify germs (like bacteria, viruses, fungi, and parasites) in the blood of patients undergoing hematopoietic stem cell transplants (HSCT). Infections can be a serious problem for these patients, so the researchers want to see if they can find specific signs of infection in blood samples taken before the transplant and up to six months afterward. They will also look at whether the presence of these germs is linked to symptoms like fever or other signs of infection.

To participate in this study, individuals must be at least 3 years old and currently enrolled in another study at the NIH Clinical Center where they will receive an HSCT. Participants need to be willing to follow the study procedures and provide consent. Over the course of the trial, which lasts up to six months, participants will donate blood samples that will be analyzed to understand how their microbial profiles change during and after the transplant process. This study aims to improve the way infections are detected and managed in patients receiving HSCT.

Gender

ALL

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.