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Investigating Early Immunophenotype and Immunosuppressive Mechanisms in Sepsis of Cancer Patients with Agranulocytosis

Investigating Early Immunophenotype and Immunosuppressive Mechanisms in Sepsis of Cancer Patients with Agranulocytosis

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500108508
Enrollment
Unknown
Registered
2025-09-01
Start date
2025-09-01
Completion date
Unknown
Last updated
2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Solid tumor or hematological malignancy

Interventions

Experimental Group 2: Hematological malignancy with Agranulocytosis and Confirmed Sepsis:NA
Control Group 2: Non-Neutropenic Patients with Confirmed Sepsis:NA
Experimental Group 1: Solid Tumor with Agranulocytosis and Confirmed Sepsis:NA
Control Group 1: Solid Tumor with Agranulocytosis and Confirmed Infection-Free Status:NA

Sponsors

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Aged between 18 and 65 years; 2. Diagnosed with solid tumor or hematological malignancy; 3. Absolute neutrophil count (ANC) < 0.5 × 10?/L; 4. Meeting diagnostic criteria for sepsis; 5. Provision of signed informed consent form with commitment to full trial participation;

Exclusion criteria

Exclusion criteria: 1. Patients with non-cancerous immunodeficiencies (e.g., HIV infection, primary immunodeficiency disorders, solid organ transplant recipients, hematopoietic stem cell transplant recipients); 2. Active autoimmune diseases (e.g., rheumatoid arthritis, systemic lupus erythematosus); 3. High-dose corticosteroid use (>=200 mg/day hydrocortisone equivalent) within 72 hours; 4. Receiving T-cell therapies (e.g., CAR-T) or treatment for graft-versus-host disease (GVHD) post-transplant; 5. Immune checkpoint inhibitor administration within 4 weeks prior; 6. Patients requiring continuous renal replacement therapy (CRRT) or extracorporeal membrane oxygenation (ECMO); 7. Pregnant or lactating patients; 8. Life expectancy <72 hours or patients transitioned to palliative care only;

Design outcomes

Primary

MeasureTime frame
Plasma/Serum Cytokine & Chemokine Profiling;Immune Checkpoint Molecule Expression;Comprehensive Profiling of Peripheral Blood Immune Cell Subsets: Phenotypic Proportions and Functional Activation Status;Monocytic HLA-DR Density (mHLA-DR);Gut Microbiome Profiling;

Countries

China

Contacts

Public ContactHuang Yifei

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

yf_huang2012@163.com+86 27 8326 1086

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026