Development of Innovative Preclinical Ex Vivo Models for the Study of Sarcomas and Metastases From Solid Tumors

Recruiting

• Conditions: Bone and Soft Tissue Tumors; Bone Metastases From Solid Tumors; Lung Metastases

• Registration Number: NCT07112989
• Lead Sponsor: Istituto Ortopedico Rizzoli

Brief Summary

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.

Detailed Description

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:

* Identification of markers that can be proposed as possible therapeutic targets for rational use of drugs;

* Identification of circulating biomarkers capable of monitoring (and predicting) disease progression;

* Identification of circulating biomarkers predictive of toxicity to treatments;

* Identification of innovative therapeutic strategies for the treatment of sarcomas and metastases; Study Tasks and Scope

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.

Study Timeline

• Study Start: 2024-09-23
• Status Verified: 2025-08
• Study First Submitted: 2025-08-01
• Study First Submitted QC: 2025-08-01
• Last Update Submitted: 2025-08-01
• Study First Posted: 2025-08-08
• Last Update Posted: 2025-08-08
• Primary Completion: 2031-09-23
• Study Completion: 2031-09-23

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 125

Inclusion Criteria

• Patients (male or female) diagnosed with sarcoma or with bone or lung metastases from solid tumors
• Age between 0 and 85 years
• Availability of sufficient and adequate biological material (tumor tissue and/or blood)
• Signed informed consent for biobanking (BIOTUM)
• Signed informed consent for use of tissue and blood samples in this study

Exclusion Criteria

• Diagnosis other than sarcoma or metastases from solid tumors
• Missing signed informed consent(s)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of tumor samples enabling the development of at least three preclinical models	7 years	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.

Secondary Outcome Measures

Name	Time	Method
Evaluation of the quality of the models	7 years	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.

Trial Locations

Locations (1)

Istituto Ortopedico Rizzoli; 🇮🇹 Bologna, Italy