Bone and Soft Tissue TumorsPREMODNCT07112989
Development of Innovative Preclinical Ex Vivo Models for the Study of Sarcomas and Metastases From Solid Tumors
An observational study of Bone and Soft Tissue Tumors and Bone Metastases From Solid Tumors, run by Istituto Ortopedico Rizzoli at 1 site in Italy.
Trial summary
The goal of this observational study is to learn how tumor tissue and blood samples from patients with sarcomas or metastases can be used to create laboratory models that help researchers study cancer behavior and test new treatments. Read more about this study
- Who is it for?
- Ages Up to 85 years
- Conditions the study is for
- Bone and Soft Tissue Tumors, Bone Metastases From Solid Tumors, Lung Metastases
- How many people
- 125 participants
- Where
- 1 siteItaly
- Study dates
- 23 Sep 2024to 23 Sep 2031
- 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 Up to 85 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The study population includes male and female patients aged 0 to 85 years who have been diagnosed with sarcoma or with bone or lung metastases from solid tumors. Only patients whose resection will provide sufficient tumor tissue that exceed what is necessary for pathological diagnosis characterization and banking will be enrolled. Participation is voluntary and requires signed informed consent for biobanking and for the use of biological samples. Approximately 125 patients are expected to be enrolled over five years (around 90 with sarcoma and 35 with metastatic disease).
Who may be able to join
- 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
Who cannot join
- Diagnosis other than sarcoma or metastases from solid tumors
- Missing signed informed consent(s)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Istituto Ortopedico Rizzoli
Bologna
Toni Ibrahim, MD Oncologist, +39 0516366199, toni.ibrahim@ior.it
About this study
The goal of this observational study is to learn how tumor tissue and blood samples from patients with sarcomas or metastases can be used to create laboratory models that help researchers study cancer behavior and test new treatments. Participants diagnosed with sarcoma or with bone or lung metastases from solid tumors will donate leftover tumor tissue and blood collected during their regular medical care. These samples will be used in the lab to build 3D models of the tumor, test drugs, and identify genetic and molecular markers. No treatments or procedures will be given as part of the study.
Read the detailed description
PREMOD is a prospective, observational, preclinical study designed to develop and optimize innovative tumor models derived from patients diagnosed with sarcomas or with bone/lung metastases from solid tumors. These models include tumor explants, primary cultures, spheroids, scaffold-based 3D cultures, 3D bioprinted models, alginate capsules, and the chorioallantoic membrane (CAM) model.
Study Objectives
Primary Objective:
- To develop and optimize innovative preclinical models for study sarcomas and metastases.
Secondary Objectives:
- Identification of markers that can be proposed as possible therapeutic targets for rational use of drugs;
- Identification of circulating biomarkers capable of monitoring (and predicting) disease progression;
- Identification of circulating biomarkers predictive of toxicity to treatments;
- Identification of innovative therapeutic strategies for the treatment of sarcomas and metastases; Study Tasks and Scope
The study includes four main research tasks:
Task 1: Optimization of innovative ex vivo preclinical models. Develop different preclinical tumour models from patient-derived tissue. Each model is optimised to study specific features of tumour biology and its interactions with the microenvironment. Success in developing the models is assessed using defined criteria such as cell viability and model reproducibility.
Task 2: Study of the natural history of sarcomas and metastases. The developed models are used to investigate tumour cell behaviour, including growth, invasiveness and interaction with the microenvironment and molecular profiling.
Task 3: Drug screening. Patient-derived models are used to evaluate the efficacy of conventional or innovative drugs as single agents or in combination. Locoregional treatments (e.g., electrochemotherapy, cryotherapy, thermoablation) may also be tested.
Task 4: Identification of prognostic markers, or predictors of response or toxicity to treatment.
Biological samples are analyzed to identify prognostic and predictive biomarkers, including circulating markers and genetic polymorphisms linked to treatment response or toxicity.
Study Size and Duration Approximately 125 patients (including about 90 with sarcoma and 35 with bone or lung metastasis from solid tumor) will be enrolled over a 5-year recruitment period (25 per year), with a total study duration of 7 years. No investigational treatments are administered to participants. All experimental work is conducted ex vivo using donated biological material.
- Keywords
- Sarcomas, Bone metastases, Lung metastases, Preclinical models
- 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 |
|---|---|---|
| Patients with Sarcoma or Bone and Lung Metastases from Solid Tumors | This group includes male and female patients aged 0-85 years diagnosed with sarcomas or with bone or lung metastases from solid tumors and undergoing in surgical removal of the tumor or performing a biopsy. 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.
Number of tumor samples enabling the development of at least three preclinical models
Number of patient-derived tumor samples that allow the successful development of at least three distinct preclinical models (e.g., spheroids, explants, scaffold-based cultures, or bioprinted constructs). This outcome assesses the feasibility and robustness of the tissue-based modeling approach.
Measured: 7 years
Secondary outcomes (1)
Evaluation of the quality of the models
Assessment of cell viability in the developed preclinical models. A model will be considered successful if at least 80% of cells are viable after 7 days of in vitro culture, as measured by standard viability assays.
Measured: 7 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2025
- Study start23 Sep 2024
- Primary completion23 Sep 2031 (estimated)
- Study completion23 Sep 2031 (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.
- 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
- 125 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituto Ortopedico Rizzoli
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07112989
- Sponsor's protocol ID
- 477/2024/Sper/IOR
- Acronym
- PREMOD
- Status last verified
- Aug 2025
- First submitted
- 1 Aug 2025
- Last updated
- 8 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of Innovative Preclinical Ex Vivo Models for the Study of Sarcomas and Metastases From Solid Tumors
- ClinicalTrials.gov ID
- NCT07112989
- Acronym / sponsor ID
- PREMOD / 477/2024/Sper/IOR
- Keywords
- Sarcomas, Bone metastases, Lung metastases, Preclinical models
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 125 participants (estimated)
- Lead sponsor
- Istituto Ortopedico RizzoliUniversity, hospital or other
- Study start
- 23 Sep 2024 (actual)
- Primary completion
- 23 Sep 2031 (estimated)
- Study completion
- 23 Sep 2031 (estimated)
- First posted
- 8 Aug 2025 (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.
The goal of this observational study is to learn how tumor tissue and blood samples from patients with sarcomas or metastases can be used to create laboratory models that help researchers study cancer behavior and test new treatments. Participants diagnosed with sarcoma or with bone or lung metastases from solid tumors will donate leftover tumor tissue and blood collected during their regular medical care. These samples will be used in the lab to build 3D models of the tumor, test drugs, and identify genetic and molecular markers. No treatments or procedures will be given as part of the study.
Detailed description
PREMOD is a prospective, observational, preclinical study designed to develop and optimize innovative tumor models derived from patients diagnosed with sarcomas or with bone/lung metastases from solid tumors. These models include tumor explants, primary cultures, spheroids, scaffold-based 3D cultures, 3D bioprinted models, alginate capsules, and the chorioallantoic membrane (CAM) model.
Study Objectives
Primary Objective:
- To develop and optimize innovative preclinical models for study sarcomas and metastases.
Secondary Objectives:
- Identification of markers that can be proposed as possible therapeutic targets for rational use of drugs;
- Identification of circulating biomarkers capable of monitoring (and predicting) disease progression;
- Identification of circulating biomarkers predictive of toxicity to treatments;
- Identification of innovative therapeutic strategies for the treatment of sarcomas and metastases; Study Tasks and Scope
The study includes four main research tasks:
Task 1: Optimization of innovative ex vivo preclinical models. Develop different preclinical tumour models from patient-derived tissue. Each model is optimised to study specific features of tumour biology and its interactions with the microenvironment. Success in developing the models is assessed using defined criteria such as cell viability and model reproducibility.
Task 2: Study of the natural history of sarcomas and metastases. The developed models are used to investigate tumour cell behaviour, including growth, invasiveness and interaction with the microenvironment and molecular profiling.
Task 3: Drug screening. Patient-derived models are used to evaluate the efficacy of conventional or innovative drugs as single agents or in combination. Locoregional treatments (e.g., electrochemotherapy, cryotherapy, thermoablation) may also be tested.
Task 4: Identification of prognostic markers, or predictors of response or toxicity to treatment.
Biological samples are analyzed to identify prognostic and predictive biomarkers, including circulating markers and genetic polymorphisms linked to treatment response or toxicity.
Study Size and Duration Approximately 125 patients (including about 90 with sarcoma and 35 with bone or lung metastasis from solid tumor) will be enrolled over a 5-year recruitment period (25 per year), with a total study duration of 7 years. No investigational treatments are administered to participants. All experimental work is conducted ex vivo using donated biological material.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with Sarcoma or Bone and Lung Metastases from Solid Tumors | – | –This group includes male and female patients aged 0-85 years diagnosed with sarcomas or with bone or lung metastases from solid tumors and undergoing in surgical removal of the tumor or performing a biopsy. 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
- Up to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study population includes male and female patients aged 0 to 85 years who have been diagnosed with sarcoma or with bone or lung metastases from solid tumors. Only patients whose resection will provide sufficient tumor tissue that exceed what is necessary for pathological diagnosis characterization and banking will be enrolled. Participation is voluntary and requires signed informed consent for biobanking and for the use of biological samples. Approximately 125 patients are expected to be enrolled over five years (around 90 with sarcoma and 35 with metastatic disease).
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- Diagnosis other than sarcoma or metastases from solid tumors
- Missing signed informed consent(s)
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
Number of tumor samples enabling the development of at least three preclinical models
Time frame: 7 years
Number of patient-derived tumor samples that allow the successful development of at least three distinct preclinical models (e.g., spheroids, explants, scaffold-based cultures, or bioprinted constructs). This outcome assesses the feasibility and robustness of the tissue-based modeling approach.
1 secondary outcome
Evaluation of the quality of the models
Time frame: 7 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 8 Aug 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.
1 site 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 and Bone Metastases From Solid Tumors, run by Istituto Ortopedico Rizzoli at 1 site 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 5 inclusion and 2 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 8 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Number of tumor samples enabling the development of at least three preclinical models (time frame: 7 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 8 Aug 2025.