Ignite Creation Date:
2025-12-24 @ 2:51 PM
Ignite Modification Date:
2026-02-22 @ 5:09 PM
Study NCT ID:
NCT03929159
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-10-14
First Post:
2019-04-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Correlating MicroRNA Changes With Sepsis Outcomes
Sponsor:
M.D. Anderson Cancer Center
Organization:
Study Overview
Official Title:
Profile of miRNA Changes in Sepsis and Surgical Trauma
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This trial studies how changes in microRNAs may correlate with sepsis outcomes. Sepsis is a type of severe infection of the blood stream, and its diagnosis may be obscured by many other conditions such as surgery, trauma, and cancer. MicroRNAs are biomarkers found in the blood and tissue. Blood samples may help correlate changes in microRNA expression to patient reactions to a sepsis infection.
Detailed Description:
PRIMARY OBJECTIVES:
I. To examine whether the cellular and viral micro ribonucleic acid (miRNA) changes in plasma and peripheral mononuclear blood cells (PMNCs) correlate with the diagnosis and outcome of sepsis.
SECONDARY OBJECTIVES:
I. To distinguish systemic inflammatory response syndrome (SIRS) without infection from sepsis and septic shock.
OUTLINE: Patients are assigned to 1 of 2 groups.
GROUP A: Patients undergo blood specimen collection at baseline (before surgery), the day after surgery, either the day of hospital discharge or the day of sepsis diagnosis, and 6 days after the baseline blood draw if still hospitalized.
GROUP B: Patients undergo blood specimen collection at baseline (day of sepsis diagnosis), the day after baseline, and on day 7 from baseline if still hospitalized.
I. To examine whether the cellular and viral micro ribonucleic acid (miRNA) changes in plasma and peripheral mononuclear blood cells (PMNCs) correlate with the diagnosis and outcome of sepsis.
SECONDARY OBJECTIVES:
I. To distinguish systemic inflammatory response syndrome (SIRS) without infection from sepsis and septic shock.
OUTLINE: Patients are assigned to 1 of 2 groups.
GROUP A: Patients undergo blood specimen collection at baseline (before surgery), the day after surgery, either the day of hospital discharge or the day of sepsis diagnosis, and 6 days after the baseline blood draw if still hospitalized.
GROUP B: Patients undergo blood specimen collection at baseline (day of sepsis diagnosis), the day after baseline, and on day 7 from baseline if still hospitalized.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2019-00833 | REGISTRY | CTRP (Clinical Trial Reporting Program) | View | |
| 2018-0757 | OTHER | M D Anderson Cancer Center | View | |
| R01GM122775 | NIH | None | https://reporter.nih.gov/quic… | View |