RecruitingNot Applicable

Identification of Markers of Poor Clinical Prognosis in Sepsis by Epigenetic Analysis

France25 participantsStarted 2025-03-20

Plain-language summary

Sepsis is a multifactorial syndrome characterized by a dynamic course and a clinical outcome dependent on several factors, and responsible for one in five deaths worldwide. The aim of this trial is to identify new prognostic markers for the progression of sepsis to septic shock, by comparing epigenetic markers between patients who have or have not developed severe forms of sepsis. The main objective of this preliminary study is to identify prognostic markers for the progression of sepsis to septic shock, i.e. to compare targeted markers between subjects with sepsis who progress to septic shock versus subjects with sepsis who do not progress to septic shock.

Who can participate

Age range

45 Years – 75 Years

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Male patients, * Patients between 45 and 75 years of age, * Patients undergoing major esophageal or digestive carcinological surgery, * Patients with post-operative gram-negative bacterial sepsis (proven or suspected in the context of organ failure). Exclusion Criteria: * patients under 45 and aged 76 and over, * female patients, * non-carcinological or minor surgery, * non-esophageal or non-digestive surgery, * Gram-positive bacterial or fungal infections in the absence of associated BGN, * patients with hematological cancer, * immunocompromised patients, * septic surgery (surgical site infection), * patients expressing opposition to data collection and analysis (clinical and/or biological) within the regulatory framework of the study, * patients under guardianship or curatorship, * patients not affiliated to a social security system or equivalent in France, * patients deprived of their liberty.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Identify prognostic markers for the progression of sepsis to septic shock

Timeframe: 18 months

Trial details

NCT IDNCT06446947

SponsorAssistance Publique Hopitaux De Marseille

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2026-09-30

Contact for this trial

Marc LEONE, MD PHD

0491968655 marc.leone@ap-hm.fr

View on ClinicalTrials.gov More Sepsis Syndrome trials