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

NCT06904053 | Recruiting

• 2 other identifiers: 10001923001923-CC
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Hematopoietic Stem Cell Transplantation

Keywords

Microbial DNA/RNA; Hematopoietic stem cell transplant (HSCT)

Outcome Measures

Primary Outcomes (1)

• Any positive clinical results for each of 5 pathogen categories

  Research blood draw at screening, during fever episodes and at follow up days 30, 100 and 180 (+/- 7 days).

  Six months

Study Arms (1)

All HSCT patients

Male or female, aged 3 years or older.

Eligibility Criteria

• Age: 3 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• National Institutes of Health Clinical Center (CC): lead

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

RECRUITING

Related Links

• NIH Clinical Center Detailed Web Page

Study Officials

• Sanchita Das, M.D.

  National Institutes of Health Clinical Center (CC)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mary M Czech, M.D.

CONTACT

(240) 447-9109; mary.czech@nih.gov

Sanchita Das, M.D.

CONTACT

(301) 496-5668; sanchita.das@nih.gov

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 29, 2025
• First Posted: April 1, 2025
• Study Start: April 9, 2025
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): December 30, 2030
• Last Updated: November 21, 2025

Record last verified: 2025-11-19

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)