Role of Transposable Elements in Septic Immune Aging | NCT06809868

Studies
Role of Transposable Elements in Septic Immune Aging

NCT06809868

Sponsor

University of California, San Francisco

Status

Recruiting

Last Update Posted

Jan 30, 2026Actual

Enrollment

116Estimated

Phase

Not provided

Conditions

Sepsis
Sepsis and Septic Shock
Sepsis With Multiple Organ Dysfunction (MOD)
Sepsis With Acute Organ Dysfunction
Sepsis, Severe
Sepsis at Intensive Care Unit
Sepsis, Severe Sepsis and Septic Shock
Sepsis, Septic Shock

Interventions

RNA and DNA Sequencing

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

Jan 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 14, 2025Actual

Primary Completion Date

Feb 14, 2028Estimated

Completion Date

Aug 14, 2028Estimated

First Submitted Date

Jan 30, 2025

First Submission Date that Met QC Criteria

Jan 30, 2025

First Posted Date

Feb 5, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 28, 2026

Last Update Posted Date

Jan 30, 2026Actual

Name	Class
National Cancer Institute (NCI)	NIH

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The goal of this observational study is to learn about how transposable element levels affect the patient outcomes in sepsis. The main questions it aims to answer is:

Do transposable elements prematurely age the immune systems of patients with sepsis?
Do transposable elements correlate with increased mortality in patients with sepsis in the ICU?
Do transposable elements correlate with increased amount of secondary infections in patients with sepsis in the ICU?

Participants will have blood drawn from them but will not be subjected to additional interventions.

Detailed Description

Not provided

Conditions Module

Conditions

Sepsis
Sepsis and Septic Shock
Sepsis With Multiple Organ Dysfunction (MOD)
Sepsis With Acute Organ Dysfunction
Sepsis, Severe
Sepsis at Intensive Care Unit
Sepsis, Severe Sepsis and Septic Shock
Sepsis, Septic Shock

Keywords

Sepsis
Transposable Elements
Immune Aging
Mortality
Secondary Infections
Critical Care Medicine (ICU)

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

6 Weeks

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

116Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patients with Sepsis		Adult patients (age 18 and older) admitted to the intensive care unit (ICU) meeting Sepsis 3 Criteria.	Genetic: RNA and DNA Sequencing
Healthy Individual Controls		Healthy individuals not admitted to the hospital.	Genetic: RNA and DNA Sequencing

Interventions

Name	Type	Description	Arm Group Labels	Other Names
RNA and DNA Sequencing	Genetic	DNA and RNA sequencing will be conducted on both control participants and patients with sepsis who are admitted to the ICU.	Healthy Individual Controls

Measure	Description	Time Frame
Immune Aging		6 weeks

Measure	Description	Time Frame
Mortality (30-day)		30 days
Secondary Infection		30 days

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age 18 or older
Admitted to ICU with sepsis (Sepsis 3 Criteria)
SOFA score of at least 2 at time of enrollment

Exclusion Criteria:

Patients on organ transplantation immunosuppression
Patients with preexisting leukopenia
Cancer patients receiving CAR-T therapy
Patients who are under 18 years of age or otherwise deemed pediatric
Patients with an ongoing bleeding diathesis (ie: DIC, hemorrhagic shock)
Patients with a chronic hemoglobin below 7.0
Patients who, prior to their ICU admission, are blood transfusion dependent

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

The study population includes adult patients admitted to the intensive care unit with sepsis with a SOFA score of at least 2. Sepsis is defined by the Sepsis 3 Criteria.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Alexendar R Perez, M.D., Ph.D	Contact	415-476-1000		Alexendar.Perez@ucsf.edu
Matthieu Legrand, M.D., Ph.D	Contact	415-476-1000		matthieu.legrand@ucsf.edu

Overall Officials

Name	Affiliation	Role
Alexendar R Perez, M.D., Ph.D	University of California, San Francisco	Principal Investigator
Judith Hellman, M.D.	University of California, San Francisco	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of California, San Francisco	Recruiting	San Francisco	California	94143	United States

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Not provided

Types

Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

MeSH Terms

Intervention Browse Module

MeSH Terms

ID	Term
D018805	Sepsis
D012772	Shock, Septic
D060085	Coinfection

ID	Term
D007239	Infections
D018746	Systemic Inflammatory Response Syndrome
D007249	Inflammation
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D012769	Shock

ID	Term
D009696	Nucleic Acids
D009706	Nucleic Acids, Nucleotides, and Nucleosides
D017421	Sequence Analysis
D005821	Genetic Techniques
D008919	Investigative Techniques