Innovative Drug Delivery Nanophotonic Platform for Implementation of Sarcoma Therapy (DEEPLY)

Istituto Ortopedico Rizzoli

Status: Enrolling

Conditions: Bone and Soft Tissue Tumors

Study type: Observational

Funder types: Other

Identifiers

NCT06599957

DEEPLY

PNRR-POC-2023- 12377696 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 2 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• Patients not affected by STSs or BSs will be excluded from the study, as well as patients with multiple primary tumors.

Trial design

30 participants in 1 patient group

Bone and soft tissue sarcomas

Description:

Patients affected by sarcoma and undergoing surgical removal of the tumor or performing a biopsy will be enrolled. Only patients whose resection will provide sufficient tumor tissue that exceed what is necessary for pathological diagnosis characterization and banking will be enrolled.