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

NCT07112989 | Recruiting

• 1 other identifier: 477/2024/Sper/IOR
• Study Type: observational
• Target: 125
• Locations: 1 country
• Sites: 1

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.

Conditions

Bone and Soft Tissue Tumors; Bone Metastases From Solid Tumors; Lung Metastases

Keywords

Sarcomas; Bone metastases; Lung metastases; Preclinical models

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Evaluation of the quality of the models

  7 years

Study Arms (1)

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.

Eligibility Criteria

• Age: Up to 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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).

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Istituto Ortopedico Rizzoli: lead

Study Sites (1)

Istituto Ortopedico Rizzoli

Bologna, Italy

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

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.

MeSH Terms

Conditions

Soft Tissue Neoplasms; Sarcoma

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type

Central Study Contacts

Toni Ibrahim, MD Oncologist

CONTACT

+39 0516366199; toni.ibrahim@ior.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 1, 2025
• First Posted: August 8, 2025
• Study Start: September 23, 2024
• Primary Completion (Estimated): September 23, 2031
• Study Completion (Estimated): September 23, 2031
• Last Updated: August 8, 2025

Record last verified: 2025-08

Locations

IT (1)