Patient-derived 3D tumor models for sarcoma and metastases
Development of Innovative Preclinical Ex Vivo Models for the Study of Sarcomas and Metastases From Solid Tumors
Istituto Ortopedico Rizzoli · NCT07112989
This project will try to turn leftover tumor and blood samples from people with sarcoma or with bone or lung metastases into lab-grown 3D tumor models to help test new treatments.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 125 (estimated) |
| Ages | N/A to 85 Years |
| Sex | All |
| Sponsor | Istituto Ortopedico Rizzoli (other) |
| Locations | 1 site (Bologna) |
| Trial ID | NCT07112989 on ClinicalTrials.gov |
What this trial studies
PREMOD is a prospective, observational project that collects leftover tumor tissue and blood from patients with sarcoma or bone/lung metastases during routine medical care. Collected samples are used to build and optimize a range of ex vivo models, including tumor explants, primary cultures, spheroids, scaffold-based 3D cultures, 3D bioprinted constructs, alginate capsules, and chorioallantoic membrane (CAM) assays. Models are evaluated for viability and reproducibility and used for drug testing and identification of genetic and circulating biomarkers related to progression or toxicity. No experimental treatments or extra procedures are administered as part of participation.
Who should consider this trial
Good fit: Ideal candidates are patients (any sex, age 0–85) diagnosed with sarcoma or with bone or lung metastases from solid tumors who can provide sufficient tumor tissue and/or blood and have signed the required consents.
Not a fit: Patients without available tumor or blood samples, those with diagnoses other than sarcoma or solid-tumor metastases, or those seeking immediate therapeutic intervention should not expect direct clinical benefit from participation.
Why it matters
Potential benefit: If successful, these patient-derived models could speed identification of effective drugs and biomarkers to better guide treatment for sarcoma and metastatic disease.
How similar studies have performed: Patient-derived ex vivo and 3D tumor models have shown promise in preclinical drug screening and biomarker discovery, but translating these findings into consistent clinical benefit remains limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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)
Where this trial is running
Bologna
- Istituto Ortopedico Rizzoli — Bologna, Italy (RECRUITING)
Study contacts
- Study coordinator: Toni Ibrahim, MD Oncologist
- Email: toni.ibrahim@ior.it
- Phone: +39 0516366199
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Bone and Soft Tissue Tumors, Bone Metastases From Solid Tumors, Lung Metastases, Sarcomas, Bone metastases, Lung metastases, Preclinical models