Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| RC-2024-2790611 | Other Grant/Funding Number | Italian Ministry of Health |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The goal of this clinical trial is to characterize the biomolecular profile of bone metastases to define the predisposing profiles of bone metastasis, in patients with breast or lung or renal carcinomas or of the gastroenteric or prostate tract with bone metastasis.
The main question it aims to answer is:
Is it possible to predict the progression of bone metastasis by identifying biomarkers as risk factors for bone metastasis?
Metastasization is a process that involves molecular change: potentially colonizable healthy tissues, particularly bone marrow, may "respond" to the production of factors released by the primary tumor, changing some of their funcional molecular characteristics in order to facilitate colonization by circulating tumor cells.
This study aims to describe the biomolecular profile of bone metastases. For this purpose, as per normal clinical practice, patients with carcinomas and who have developed bone metastases will undergo sampling of the metastases and primary tumors.
The activities will have multidisciplinary management. The study will include patients with carcinoma with bone metastases for whom the collection of biological material from the primary lesion and/or bone metastasis is an integral part of the diagnostic-therapeutic procedure or patients for whom, by clinical practice, a biopsy collection is performed because:
These samples will later be analyzed from a molecular point of view in order to identify a biomolecular profile that can help in defining profiles predisposing to bone metastasis and profiles predisposing to pathological fracture risk.
Unsupervised analysis of the emerged transcriptomes will be conducted:
To eliminate analysis error and bias, analyses will be conducted on fresh samples from needle biopsy or intraoperative sampling.
Emerging evidence on transcriptomic analysis will be validated with protein analysis methods and compared with evidence alreadỳ available in the literature.
The analysis being conducted for this study does not influence clinical practice, and all procedures are part of normal clinical practice in the management of patients with bone metastases from carcinoma.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bone metastasis | Other | Patients with breast or lung or renal or gastroenteric tract or prostate carcinomas with bone metastases |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biomolecular profile of bone metastases | Genetic | Describe the biomolecular profile of bone metastases |
|
| Measure | Description | Time Frame |
|---|---|---|
| Bone metastasis profiling | Characterizing the biomolecular profile of bone metastasis to define the predisposing profiles of bone metastasis. Transcriptional profile of
| up to 100 weeks |
| Fracture pathological profiling | Characterizing the biomolecular profile of bone metastasis to define the predisposing risk profiles of fracture pathological. Fracture event yes/no and association with primary outcomes. | up to 100 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison between the biomolecular profile of the mestastases and the primary tumor | Trascriptional profile of:
| up to 100 weeks |
| Comparison between the biomolecular profiles of osteolytic and osteosclerotic metastases |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Andrea Sambri, MD | Contact | 0512142680 | andrea.sambri@aosp.bo.it |
| Name | Affiliation | Role |
|---|---|---|
| Andrea Sambri, MD | IRCCS Azienda Ospedaliero-Universitaria di Bologna | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IRCCS Azienda Ospedaliero-Universitaria di Bologna | Recruiting | Bologna | Bologna | 40138 | Italy |
Not provided
| ID | Term |
|---|---|
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D009385 | Neoplastic Processes |
| D009369 | Neoplasms |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Trascriptional profile of:
|
| up to 100 weeks |
| Measuring PTH-rp (parathormone-related peptide) levels and the risk of pathologic facture | Dosage of PTHrp | Every 3-6 months |