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NCT06904053 · ClinicalTrials.gov registry record

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

A clinical trial of Hematopoietic Stem Cell Transplantation, sponsored by National Institutes of Health Clinical Center (CC).

Recruiting
Registry status
30
Enrollment target
1
Study location

NCT06904053 is a study of Hematopoietic Stem Cell Transplantation that is actively recruiting participants, run by National Institutes of Health Clinical Center (CC). The registered enrollment target is 30 participants, below the 9,789-participant average among 26 other Hematopoietic Stem Cell Transplantation trials with a reported enrollment target (100% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT06904053, a study of Hematopoietic Stem Cell Transplantation, is actively recruiting participants, sponsored by National Institutes of Health Clinical Center (CC).

RECRUITING
Registry status
30 participants
Enrollment target
1
Study location

Study 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.

Study Locations (1)

Maryland

  • National Institutes of Health Clinical Center - Bethesda

Trial Details

FieldValue
Enrollment Target 30 participants
Start Date 2025-04-09
Est. Completion 2030-12-30

What the Registry Record Tells You About NCT06904053

The ClinicalTrials.gov registry entry for NCT06904053 describes a study currently listed as recruiting, categorized as an unspecified phase. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 9,789-participant average among 26 other Hematopoietic Stem Cell Transplantation trials with a reported enrollment target (100% lower). The listed sponsor is National Institutes of Health Clinical Center (CC), which has 338 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Hematopoietic Stem Cell Transplantation appearing as the primary indexed condition, and to 0 interventions.

NCT06904053 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.

Frequently Asked Questions

What is clinical trial NCT06904053 about?

NCT06904053 is a clinical study titled "Metagenomics Next-generation Sequencing Approach to Detect Microbial DNA/RNA Overtime in Individuals Undergoing Hematopoietic Stem Cell Transplant". 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 identificati...

What is the current status of trial NCT06904053?

This trial is currently recruiting. The enrollment target is 30 participants. The study started on 2025-04-09. Estimated completion is 2030-12-30.

What conditions does trial NCT06904053 study?

This clinical trial studies the following conditions: Hematopoietic Stem Cell Transplantation.

Who is sponsoring clinical trial NCT06904053?

This trial is sponsored by National Institutes of Health Clinical Center (CC), which has 338 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06904053 being conducted?

This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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