Role of Transposable Elements in Septic Immune Aging

NCT06809868 | Recruiting

• 1 other identifier: 23-39420
• Study Type: observational
• Target: 116
• Locations: 1 country
• Sites: 1

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:

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

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)

Outcome Measures

Primary Outcomes (1)

• Immune Aging

  6 weeks

Secondary Outcomes (2)

• Mortality (30-day)

  30 days

• Secondary Infection

  30 days

Study Arms (2)

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

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; Patients with Sepsis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Francisco: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94143, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Serum, Plasma, RNA, and DNA from patients with sepsis will be retained and analyzed as part of this study.

MeSH Terms

Conditions

Sepsis; Shock, Septic; Coinfection

Interventions

RNA; Sequence Analysis, DNA

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Intervention Hierarchy (Ancestors)

Nucleic Acids; Nucleic Acids, Nucleotides, and Nucleosides; Sequence Analysis; Genetic Techniques; Investigative Techniques

Study Officials

• 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

• Matthieu Legrand, M.D., Ph.D

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Central Study Contacts

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Weeks
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 30, 2025
• First Posted: February 5, 2025
• Study Start: February 14, 2025
• Primary Completion (Estimated): February 14, 2028
• Study Completion (Estimated): August 14, 2028
• Last Updated: January 30, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE

Locations

US (1)