About this trial
DEEPLY aims to improve sarcoma therapy by the development of an innovative nanophotonic delivery approach to be applied in the future as an integrated local therapy for patients with inoperable tumors or with oligometastases. The major aim of the project is the development of innovative nanocarriers loaded with chemotherapeutic agents, whose delivery will be improved by the use of an optic fiber (optoporation). After the synthesis, and characterization of NPs, a prototype will be produced and preclinically validated on patient-derived biological material. This wide comprehensive methodological approach will ensure the obtainment of robust data to be faster exploited toward clinical applications.
Eligibility criteria
Qualifiers
Patients eligible for the study will be male or female, with an age ranging from 0- to 85 years, undergoing surgery or biopsy for STSs or BSs including osteosarcomas.
Included patients may have undergone or may be still in treatment with chemotherapy (also neo-adjuvant settings), targeted therapy, radiotherapy, or combination therapy.
IRST will enroll only adult patients (age > 18 years).
Signed informed consent from all subjects enrolled in the study. IOR patients will have to sign both the specific project Informed Consent and the IOR Biobank Informed consent.
Disqualifiers
Patients not affected by STSs or BSs will be excluded from the study, as well as patients with multiple primary tumors.
Trial design
Treatments tested in this trial
- Not listed
Trial groups
Sponsors and collaborators
Istituto Ortopedico Rizzoli
Lead sponsor
Università Degli Studi del Sannio Dipartimento di Ingegneria Benevento
Collaborator
IRCCS Istituto Romagnolo per lo Studio dei Tumori Dino Amadori Meldola
Collaborator