Bone and Soft Tissue TumorsDEEPLYNCT06599957
Innovative Drug Delivery Nanophotonic Platform for Implementation of Sarcoma Therapy
An observational study of Bone and Soft Tissue Tumors, run by Istituto Ortopedico Rizzoli at 2 sites in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 to 85 years
- Conditions the study is for
- Bone and Soft Tissue Tumors
- How many people
- 30 participants
- Where
- 2 sitesItaly
- Study dates
- 30 Aug 2024to 30 Aug 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 85 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Patients not affected by STSs or BSs will be excluded from the study, as well as patients with multiple primary tumors.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Italy2 sites, 2 recruiting
- Recruiting
Istituto Ortopedico Rizzoli-OSOTT
Bologna, Emilia-Romagna, 40136
Toni Ibrahim, MD Oncologist, +39 0516366199, toni.ibrahim@ior.it
- Recruiting
IRCCS Istituto Romagnolo per lo Studio dei Tumori Dino Amadori
Meldola, Emilia-Romagna, 47014
Alessandro De Vita, MD, +39 0543739239, alessandro.devita@irst.emr.it
About this study
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
- Medical subject headings
- Soft Tissue Neoplasms, Sarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years
Secondary outcomes (1)
Secondary Objectives
The study will have the following secondary aims:
- to establish primary cultures and explants of human STSs and BSs including osteosarcomas, through different in vitro models (2D and 3D); II. to compare the efficacy of innovative NPs with standard and conventional chemotherapeutic drugs employed for the treatment of patients with sarcomas; III. to study the impact of a new delivery system on cancer cell lines, primary cultures and explants derived from fresh surgical specimen.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start30 Aug 2024
- Primary completion30 Aug 2026 (estimated)
- Study completion30 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone and Soft Tissue TumorsStudies of the same condition, open and under way.
- More trials run by Istituto Ortopedico RizzoliThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituto Ortopedico Rizzoli
- Sponsor type
- University, hospital or other
- Collaborators
- Università Degli Studi del Sannio Dipartimento di Ingegneria Benevento, IRCCS Istituto Romagnolo per lo Studio dei Tumori Dino Amadori Meldola
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06599957
- Sponsor's protocol ID
- DEEPLY
- Other IDs
- PNRR-POC-2023- 12377696
- Acronym
- DEEPLY
- Status last verified
- Sep 2025
- First submitted
- 10 Sep 2024
- Last updated
- 22 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Innovative Drug Delivery Nanophotonic Platform for Implementation of Sarcoma Therapy
- ClinicalTrials.gov ID
- NCT06599957
- Acronym / sponsor ID
- DEEPLY / DEEPLY
- Conditions
- Bone and Soft Tissue Tumors
- Keywords
- sarcomas, nanocarriers, therapy, nanophotonic
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Istituto Ortopedico RizzoliUniversity, hospital or other
- Collaborators
- Università Degli Studi del Sannio Dipartimento di Ingegneria Benevento, IRCCS Istituto Romagnolo per lo Studio dei Tumori Dino Amadori Meldola
- Study start
- 30 Aug 2024 (actual)
- Primary completion
- 30 Aug 2026 (estimated)
- Study completion
- 30 Aug 2026 (estimated)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 2 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- Patients not affected by STSs or BSs will be excluded from the study, as well as patients with multiple primary tumors.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Primary Objective
Time frame: 2 years
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.
1 secondary outcome
Secondary Objectives
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bone and Soft Tissue Tumors, run by Istituto Ortopedico Rizzoli at 2 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Toni Ibrahim, MD Oncologist (+39 0516366199, toni.ibrahim@ior.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Objective (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2025.