Innovative Drug Delivery Nanophotonic Platform for Implementation of Sarcoma Therapy

NCT06599957 | Recruiting DMC

• 2 other identifiers: DEEPLYPNRR-POC-2023- 12377696
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Bone and Soft Tissue Tumors

Keywords

sarcomas; nanocarriers; therapy; nanophotonic

Outcome Measures

Primary Outcomes (1)

• Primary Objective

  The primary aim of the study will be to determine on primary cells or explants the efficacy of the innovative nanotechnology formulations established in the project.

  2 years

Secondary Outcomes (1)

• Secondary Objectives

  2 years

Study Arms (1)

Bone and soft tissue sarcomas

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.

Eligibility Criteria

• Age: 2 Years - 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

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.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Istituto Ortopedico Rizzoli: lead
• Università Degli Studi del Sannio Dipartimento di Ingegneria Benevento: collaborator
• IRCCS Istituto Romagnolo per lo Studio dei Tumori Dino Amadori Meldola: collaborator

Study Sites (2)

Istituto Ortopedico Rizzoli-OSOTT

Bologna, Emilia-Romagna, 40136, Italy

RECRUITING

IRCCS Istituto Romagnolo per lo Studio dei Tumori Dino Amadori

Meldola, Emilia-Romagna, 47014, Italy

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

This is a biological experimental prospective study on clinical specimens from patients undergoing surgery for soft tissue and bone sarcomas. The study is planned to obtain 15 biological samples suitable for the establishment of the aforementioned experimental models over its entire duration.

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: September 10, 2024
• First Posted: September 19, 2024
• Study Start: August 30, 2024
• Primary Completion (Estimated): August 30, 2026
• Study Completion (Estimated): August 30, 2026
• Last Updated: September 22, 2025

Record last verified: 2025-09

Locations

IT (2)