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CompletedNCT07689266Updated Jul 8, 2026

Soluble Immune Checkpoints in Intra-Abdominal Infections

An observational study in Intra Abdominal Infections, sponsored by Istanbul Training and Research Hospital. Completed at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-08.

Sponsored by Istanbul Training and Research Hospital · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
75
Ages
18 Years to 85 Years
Sex
All
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Study summary

Intraabdominal infections is a life-threatening syndrome with a high incidence and a significant economic burden. The early-stage cytokine storm and the late-stage immunosuppression contribute to the mortality of sepsis. Immune checkpoints expressed on lymphocytes and antigen-presenting cells (APCs) play a crucial role in the pathogenesis of sepsis by regulating immune dysfunction. Specific therapies targeting immune checkpoints have shown great potential in animal and preclinical studies, paving the way for further clinical research. In this study, the significance of serum immune checkpoints - sCD25 (IL-2Ra), 4-1BB, B7.2 (CD86), Free Active TGF-beta1, CTLA-4, PD-L1, PD-1, Tim-3, LAG-3, and Galectin-9 - will be investigated in patients with intraabdominal infection.

Read the detailed description

The abdominal region is the second most common source of sepsis and secondary peritonitis. The most frequent causes of abdominal infections are perforation, ischemic necrosis, or penetrating injuries to intra-abdominal organs. Management consists of infection source control, restoration of gastrointestinal (GI) function, systemic antimicrobial therapy, and support of organ function. Despite advances in care, mortality following secondary peritonitis remains high. Excluding patient-related factors such as age or comorbidities that cannot be influenced during intervention, delays in surgical intervention and failure to achieve source control are the main determinants of outcomes.

Sepsis is defined as life-threatening organ dysfunction caused by a dysregulated host response to infection and accounted for approximately 11 million deaths worldwide in 2017, representing 19.7% of all global deaths. Early deaths in sepsis are typically due to septic shock caused by a cytokine storm. In contrast, late deaths result from the inability to clear primary infections and the development of secondary infections due to a state of immunosuppression.

Multiple mechanisms contribute to immune dysfunction in sepsis. Immune checkpoints, which assist in T cell activation, play critical roles in this process. Immune checkpoint molecules expressed on lymphocytes and antigen-presenting cells (APCs) - including CD28, cytotoxic T-lymphocyte antigen 4 (CTLA-4), CD80, CD86, programmed death-1 (PD-1), and programmed death-ligand 1 (PD-L1) - as well as CD40 and CD40L, OX40 and OX40L, 4-1BB and 4-1BBL, B and T lymphocyte attenuator (BTLA), and the T cell immunoglobulin mucin (Tim) family, serve as co-signaling molecules for T cell activation and immune regulation. Immune checkpoints exert a dual effect on the host response during sepsis. On one hand, during pathogen invasion, immune checkpoints provide critical secondary signals that help APCs activate T cells. Activated T cells and APCs create a positive feedback loop, triggering the cytokine storm. On the other hand, immune checkpoints also regulate T cell activation and inhibition in the late phase of sepsis, leading to T cell anergy and apoptosis.

CTLA-4, also known as CD152, is a competitive receptor for CD28 and plays a negative regulatory role in the immune response of inflammatory diseases by modulating CD28-mediated T cell costimulation. CTLA-4 is also expressed on T regulatory (Treg) cells and temporarily blocks their immune effects. Anti-CTLA-4-based immunotherapy has shown a dose-dependent effect in reducing sepsis-induced apoptosis in a cecal ligation and puncture (CLP) mouse model of sepsis. However, it has minimal effects on inflammatory cytokines.

PD-1, an inhibitory receptor of the CD28 family, is mainly expressed on lymphocytes, dendritic cells (DCs), monocytes, and macrophages. PD-L1, another member of the B7 family and the primary ligand of PD-1, can also be found on lymphocytes, DCs, monocytes, and macrophages. PD-1 and PD-L1 play critical roles in the immunosuppressive state of sepsis and may serve as valuable tools for assessing immune status and as potential therapeutic targets in sepsis. Various studies have confirmed that PD-1, PD-L1, and PD-L2 expression on monocytes and T lymphocytes is increased in septic patients, contributing to a novel immune regulatory system involved in immune dysfunction during sepsis. PD-1 expression on monocytes and T cell repertoire diversity have shown a positive correlation with serum interleukin levels and have been predictive of mortality in patients with septic shock. PD-L1 expression on neutrophils and monocytes has also been associated with risk stratification and mortality in septic patients.

For these reasons, elucidating the roles of immune checkpoints in the pathogenesis of sepsis and the use of immunotherapy hold great potential for sepsis treatment. Although there are limited studies in the literature on the expression of PD-1, PD-L1, PD-L2, and CTLA-4 on T cells and monocytes in sepsis patients, no studies have focused on these markers specifically in intra-abdominal infection patients or on their soluble forms in serum.

02

Conditions studied

  • Intra Abdominal Infections

Keywords

  • Intestinal Perforation
  • Sepsis
  • Immune checkpoints
03

In context

Intraabdominal Infections

129 studies on the registry are indexed under Intraabdominal Infections; 15 are open to participants now.

This study's enrollment of 75 is below the median of 174 across 48 observational studies indexed under Intraabdominal Infections.

Browse Intraabdominal Infections studies →

Lead sponsor

Istanbul Training and Research Hospital is the lead sponsor of 66 studies on the registry; 15 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Patients with intraabdominal infections due to gastrointestinal pathologies

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients with intraabdominal infections due to gastrointestinal pathologies

Exclusion criteria

Exclusion Criteria:

  • Malignities
  • Pregnancy
  • Immune deficiency
  • Patients without intraabdominal infections
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
75 participants (actual)
Patient registry
No

Groups and cohorts

  • Severe Intraabdominal Infection

    Severe Intraabdominal Infection patients with qSOFA 2 and 3

    Diagnostic Test: Soluble Immune checkpoint levels

  • Mild Intraabdominal Infection

    Mild Intraabdominal Infection patients with qSOFA 0 and 1

    Diagnostic Test: Soluble Immune checkpoint levels

  • Control

    Healthy Volunteers without intraabdominal infection

    Diagnostic Test: Soluble Immune checkpoint levels

Interventions

  • Diagnostic testSoluble Immune checkpoint levels

    Soluble Immune checkpoint levels of the groups before any treatments

06

What researchers measure

Primary outcomes

  1. Soluble Immune checkpoint levels

    sCD25 (IL-2Ra), 4-1BB, B7.2 (CD86), Free Active TGF-β1, CTLA-4, PD-L1, PD-1, Tim-3, LAG-3, Galectin-9

    Time frame: December 2023- December 2024

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Study locations

1 site
  • Istanbul Training and Research Hospital
    Istanbul, 34098, Turkey (Türkiye)
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References and documents

Publications

  • Huang CM, Xu XJ, Qi WQ, Ge QM. Prognostic significance of soluble CD25 in patients with sepsis: a prospective observational study. Clin Chem Lab Med. 2022 Feb 28;60(6):952-958. doi: 10.1515/cclm-2022-0068. Print 2022 May 25. PubMed 35230752 ↗
  • Moar P, Tandon R. Galectin-9 as a biomarker of disease severity. Cell Immunol. 2021 Mar;361:104287. doi: 10.1016/j.cellimm.2021.104287. Epub 2021 Jan 14. PubMed 33494007 ↗
  • Kim U, Lee S, Han KS, Kim SJ, Lee S, Park DW, Song J. Clinical Value of Galectin-9, Soluble TREM-1, and Soluble CD25 Among Critically Ill Patients with Organ Failure in the Emergency Department: A Prospective Observational Study. Diagnostics (Basel). 2025 Oct 23;15(21):2677. doi: 10.3390/diagnostics15212677. PubMed 41225969 ↗

Individual participant data

Plan to share: Undecided

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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Dec 2023 to primary completion in Dec 2024, 12 months.

Of 24 observational studies under Intraabdominal Infections, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 35. This study's 12 months is close to that.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 1, 2026
First posted
Jul 8, 2026
StartActual
Dec 1, 2023
Primary completionActual
Dec 31, 2024
CompletionActual
Aug 1, 2025
Last update
Jul 8, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 8, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07689266
Lead sponsor
Istanbul Training and Research Hospital
Responsible party
Ufuk Oguz Idiz (Assoc. Prof. MD. PhD, Istanbul Training and Research Hospital) — Principal investigator
First posted
Jul 8, 2026
Start date
Dec 1, 2023
Primary completion
Dec 31, 2024
Completion
Aug 1, 2025
Last update
Jul 8, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

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