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The goal of this observational study is to learn how tumor tissue and blood samples from patients with sarcomas or metastases can be used to create laboratory models that help researchers study cancer behavior and test new treatments. Participants diagnosed with sarcoma or with bone or lung metastases from solid tumors will donate leftover tumor tissue and blood collected during their regular medical care. These samples will be used in the lab to build 3D models of the tumor, test drugs, and identify genetic and molecular markers. No treatments or procedures will be given as part of the study.
PREMOD is a prospective, observational, preclinical study designed to develop and optimize innovative tumor models derived from patients diagnosed with sarcomas or with bone/lung metastases from solid tumors. These models include tumor explants, primary cultures, spheroids, scaffold-based 3D cultures, 3D bioprinted models, alginate capsules, and the chorioallantoic membrane (CAM) model.
Study Objectives
Primary Objective:
- To develop and optimize innovative preclinical models for study sarcomas and metastases.
Secondary Objectives:
The study includes four main research tasks:
Task 1: Optimization of innovative ex vivo preclinical models. Develop different preclinical tumour models from patient-derived tissue. Each model is optimised to study specific features of tumour biology and its interactions with the microenvironment. Success in developing the models is assessed using defined criteria such as cell viability and model reproducibility.
Task 2: Study of the natural history of sarcomas and metastases. The developed models are used to investigate tumour cell behaviour, including growth, invasiveness and interaction with the microenvironment and molecular profiling.
Task 3: Drug screening. Patient-derived models are used to evaluate the efficacy of conventional or innovative drugs as single agents or in combination. Locoregional treatments (e.g., electrochemotherapy, cryotherapy, thermoablation) may also be tested.
Task 4: Identification of prognostic markers, or predictors of response or toxicity to treatment.
Biological samples are analyzed to identify prognostic and predictive biomarkers, including circulating markers and genetic polymorphisms linked to treatment response or toxicity.
Study Size and Duration Approximately 125 patients (including about 90 with sarcoma and 35 with bone or lung metastasis from solid tumor) will be enrolled over a 5-year recruitment period (25 per year), with a total study duration of 7 years. No investigational treatments are administered to participants. All experimental work is conducted ex vivo using donated biological material.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with Sarcoma or Bone and Lung Metastases from Solid Tumors | This group includes male and female patients aged 0-85 years diagnosed with sarcomas or with bone or lung metastases from solid tumors and undergoing in surgical removal of the tumor or performing a biopsy. Only patients whose resection will provide sufficient tumor tissue that exceed what is necessary for pathological diagnosis characterization and banking will be enrolled. |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of tumor samples enabling the development of at least three preclinical models | Number of patient-derived tumor samples that allow the successful development of at least three distinct preclinical models (e.g., spheroids, explants, scaffold-based cultures, or bioprinted constructs). This outcome assesses the feasibility and robustness of the tissue-based modeling approach. | 7 years |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of the quality of the models | Assessment of cell viability in the developed preclinical models. A model will be considered successful if at least 80% of cells are viable after 7 days of in vitro culture, as measured by standard viability assays. | 7 years |
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Inclusion Criteria:
Exclusion Criteria:
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The study population includes male and female patients aged 0 to 85 years who have been diagnosed with sarcoma or with bone or lung metastases from solid tumors. Only patients whose resection will provide sufficient tumor tissue that exceed what is necessary for pathological diagnosis characterization and banking will be enrolled. Participation is voluntary and requires signed informed consent for biobanking and for the use of biological samples. Approximately 125 patients are expected to be enrolled over five years (around 90 with sarcoma and 35 with metastatic disease).
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Toni Ibrahim, MD Oncologist | Contact | +39 0516366199 | toni.ibrahim@ior.it |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Istituto Ortopedico Rizzoli | Recruiting | Bologna | Italy |
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| ID | Term |
|---|---|
| D012983 | Soft Tissue Neoplasms |
| D012509 | Sarcoma |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
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Tumor tissue and peripheral blood samples will be collected from participants during standard diagnostic or therapeutic procedures. Tissue samples may include material from biopsies or surgical resections (primary tumors, recurrences, or metastases) that is in excess of what is needed for clinical diagnosis. Blood samples will be collected at predefined timepoints (e.g., diagnosis, post-treatment, follow-up) and processed to isolate serum, plasma, and mononuclear cells.