Mayo Clinic Rochester
Rochester, Minnesota, 55905, United States
Location status: Recruiting
Location contact
Aadel A Chaudhuri, M.D., Ph.D.
PRINCIPAL_INVESTIGATOR
Derek E Vanmeter
CONTACT
NCT Number: NCT06817408
This is a prospective, non-randomized study investigating if organ damage and immune changes can be measured by liquid biopsy NGS through advanced analytical methods.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Rochester, Minnesota, 55905, United States
Location status: Recruiting
Aadel A Chaudhuri, M.D., Ph.D.
PRINCIPAL_INVESTIGATOR
Derek E Vanmeter
CONTACT
To determine the sample size needed to derive a signature matrix to identify novel biomarkers in sepsis, investigators performed a mathematical modeling exercise of the lower limits of sensitivity of this liquid biopsy approach. The detection limit of cell-free nucleic acid analysis is determined in part by the number of independent transcripts or "reporters" that are interrogated. Using an established and independently validated binomial model that was previously applied to the prediction of circulating tumor nucleic acid detection limits, investigators estimated the probability of cell-free nucleic acid detection in sepsis patients based on the number of unique tissue-specific reporters (i.e., hepatic transcripts that may reflect disease severity). This yields a result of n=18 per group to achieve 0.90 power at alpha=0.05. The investigators will thus plan to analyze data from n=18 per cell/tissue type to derive the signature matrix for this project.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
One additional blood draw in the Emergency Department as part of their standard of care visit.
Time frame: From date of patient enrollment until date of death for any cause or up to 1 year after patient enrollment date, whichever comes first.
Overall survival
Time frame: Up to 1 year after patient enrollment date
Time for patient in ICU
Time frame: Up to 1 year after patient enrollment date
Days
Time frame: Up to 1 year after patient enrollment date
If patient needed renal replacement therapy during duration on study.
Time frame: Up to 1 year after patient enrollment date
Contact information is provided by the study sponsor or research team.
Mayo Clinic
Other
Cell-free DNA Epigenomics to Track the Dynamics of Organ Damage and Immune Exhaustion During Sepsis
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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