Detecting Microbial DNA/RNA in Patients Undergoing Stem Cell Transplant
Metagenomics Next-Generation Sequencing Approach to Detect Microbial DNA/RNA Overtime in Individuals Undergoing Hematopoietic Stem Cell Transplant
This study is testing a new way to find germs in the blood of patients getting stem cell transplants to see if it can help understand infections better.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 30 (estimated) |
| Ages | 3 Years to 100 Years |
| Sex | All |
| Sponsor | National Institutes of Health Clinical Center (CC) NIH |
| Locations | 1 site (Bethesda, Maryland) |
| Trial ID | NCT06904053 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the effectiveness of metagenomic next-generation sequencing (mNGS) in detecting microbial signatures in patients undergoing hematopoietic stem cell transplantation (HSCT). Participants will provide blood samples before the transplant and for six months afterward, allowing researchers to analyze changes in microbial DNA/RNA over time. The study will also explore correlations between microbial identification and clinical features of infection, such as fever. By comparing mNGS results with routine clinical tests, the study seeks to enhance understanding of infections in immunocompromised patients.
Who should consider this trial
Good fit: Ideal candidates include individuals aged 3 years or older who are co-enrolled in another study at the NIH Clinical Center and are undergoing HSCT.
Not a fit: Patients with conditions that contraindicate participation, as determined by the investigator, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved detection and management of infections in patients undergoing HSCT.
How similar studies have performed: Other studies utilizing metagenomic sequencing approaches have shown promise in detecting infections, suggesting potential success for this novel application.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Bethesda, Maryland
- National Institutes of Health Clinical Center — Bethesda, Maryland, United States (Recruiting)
Study contacts
- Principal investigator: Sanchita Das, M.D. — National Institutes of Health Clinical Center (CC)
- Study coordinator: Mary M Czech, M.D.
- Email: mary.czech@nih.gov
- Phone: (240) 447-9109
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.