Protocol Details
Metagenomics Next-Generation Sequencing Approach to Detect Microbial DNA/RNA Overtime in Individuals Undergoing Hematopoietic Stem Cell Transplant
This study is currently recruiting participants.
Summary
Number |
001923-CC |
Sponsoring Institute |
National Institutes of Health Clinical Center (CC) |
Recruitment Detail |
Type: Participants currently recruited/enrolled
Gender: Male & Female
Min Age: 3 Years
Max Age: 100 Years |
Referral Letter Required |
Yes |
Population Exclusion(s) |
Fetuses;
Neonates |
Keywords |
Microbial DNA/RNA;
Hematopoietic stem cell transplant (HSCT) |
Recruitment Keyword(s) |
None |
Condition(s) |
Hematopoietic Stem Cell Transplantation |
Investigational Drug(s) |
None |
Investigational Device(s) |
None |
Intervention(s) |
None |
Supporting Site |
NIH Clinical Center |
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
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.
Citations:
Not Provided
Contacts:
Clinical Trials Number:
NCT06904053