Development of Innovative Preclinical Ex Vivo Models for the Study of Sarcomas and Metastases From Solid Tumors
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeUp to 85
SponsorIstituto Ortopedico Rizzoli
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
Diagnosis other than sarcoma or metastases from solid tumors
Missing signed informed consent(s)
Trial 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).
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
125 Participants
are grouped into 1 trial groupGroup A: Patients with Sarcoma or Bone and Lung Metastases from Solid Tumors
Trial outcomes
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.
Time frame
7 yearsSecondary outcomes
1
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.
Time frame
7 yearsSponsors and contacts
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Source ClinicalTrials.gov