Analysis of immune profiles from peripheral blood mononuclear cells (PBMCs) as a non-invasive diagnostic biomarker for therapy response and prognosis in soft tissue sarcomas

Analysis of immune profiles from peripheral blood mononuclear cells (PBMCs) as a non-invasive diagnostic biomarker for therapy response and prognosis in soft tissue sarcomas - SARCIMMUNE

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00036263

Enrollment

100

Registered

2025-02-25

Start date

2025-01-01

Completion date

Unknown

Last updated

2026-03-02

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

Conditions

C49

Interventions

Group 1: Patients with soft tissue sarcoma undergoing first-line chemotherapy and regional hyperthermia. Blood sampling for PBMC-based analysis at defined timepoints before each preoperative chemother

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Patients with biopsy-confirmed soft tissue sarcoma. 2. Planned multimodal first-line systemic therapy consisting of chemotherapy and regional deep hyperthermia.

Exclusion criteria

Exclusion criteria: Severe anemia, intensive care stay, unstable circulation, dementia patients, pregnant or breastfeeding women, minors, patients unable to provide consent, emergency patients, patients under legal guardianship, immunosuppressed patients, prior chemotherapy, active uncontrolled additional disease.

Design outcomes

Primary

Measure	Time frame
Detection of immune signatures/biomarkers under multimodal systemic therapy: Patients undergoing treatment for a soft tissue sarcoma will have peripheral venous blood drawn (a maximum total volume of 27 ml per collection) before and during multimodal therapy (before each cycle of hyperthermia/chemotherapy) and postoperatively. Additional study-related visits outside routine clinical care are not planned. Whenever possible, blood collection should be integrated into routine blood draws to avoid additional punctures. The study follows the "prospective-specimen-collection, retrospective-blinded-evaluation (PRoBE) design," which has been specifically developed for biomarker research. In this design, samples are prospectively collected from the target population for which the biomarker is intended. The samples and clinical data are initially archived without knowledge of disease progression. Once the disease course is determined at the end of the study period and a sufficient number of patients can be assigned to individual groups, the pseudonymized samples are quantified in a blinded manner. Subsequently, the samples are unblinded and assigned to the respective groups for further statistical analysis. Analysis Methods for Blood and Blood Components: - Analysis of PBMCs from venous blood - Single-cell genomics/Single-cell RNA sequencing (scRNA-seq) to identify and quantify specific molecular signatures associated with response to multimodal therapy - Detection of tumor-specific translocations (e.g., quantitative PCR, digital droplet PCR, next-generation sequencing, etc.) - Sequencing of tumor-specific point mutations (e.g., Sanger sequencing, next-generation sequencing) - Whole circulating DNA sequencing (next-generation sequencing) to identify additional tumor-specific alterations such as copy number alterations - Analysis of epigenetic modifications	—

Measure

Time frame

Detection of immune signatures/biomarkers under multimodal systemic therapy: Patients undergoing treatment for a soft tissue sarcoma will have peripheral venous blood drawn (a maximum total volume of 27 ml per collection) before and during multimodal therapy (before each cycle of hyperthermia/chemotherapy) and postoperatively. Additional study-related visits outside routine clinical care are not planned. Whenever possible, blood collection should be integrated into routine blood draws to avoid additional punctures. The study follows the "prospective-specimen-collection, retrospective-blinded-evaluation (PRoBE) design," which has been specifically developed for biomarker research. In this design, samples are prospectively collected from the target population for which the biomarker is intended. The samples and clinical data are initially archived without knowledge of disease progression. Once the disease course is determined at the end of the study period and a sufficient number of patients can be assigned to individual groups, the pseudonymized samples are quantified in a blinded manner. Subsequently, the samples are unblinded and assigned to the respective groups for further statistical analysis. Analysis Methods for Blood and Blood Components: - Analysis of PBMCs from venous blood - Single-cell genomics/Single-cell RNA sequencing (scRNA-seq) to identify and quantify specific molecular signatures associated with response to multimodal therapy - Detection of tumor-specific translocations (e.g., quantitative PCR, digital droplet PCR, next-generation sequencing, etc.) - Sequencing of tumor-specific point mutations (e.g., Sanger sequencing, next-generation sequencing) - Whole circulating DNA sequencing (next-generation sequencing) to identify additional tumor-specific alterations such as copy number alterations - Analysis of epigenetic modifications

—

Secondary

Measure	Time frame
1. Comparison of the obtained immune signatures/biomarkers with radiologic response to multimodal therapy. 2. Comparison of the obtained immune signatures/biomarkers with histopathologic response to multimodal therapy. 3. Analysis of the obtained immune signatures/biomarkers with regard to prognosis after multimodal therapy.	—

Countries

Germany

Contacts

Public ContactLuc M. Berclaz

LMU Klinikum

luc.berclaz@med.uni-muenchen.de04989440074768

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Mar 14, 2026