Biomolecular Markers of Bone Metastasis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Biomolecular profile of bone metastases.
- Who it may be relevant to
- Registry conditions: Bone Metastasis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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?
Detailed description
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:
* histologic evaluation of the primary or metastatic lesion has been requested; * a pathologic fracture to be treated surgically occurs; * prophylactic orthopedic stabilization is required.
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:
1. regardless of tumor histotype (in order to highlight any common facilitating factors for bone metastasis and osteolytic activity), 2. by histotype, 3. by type of metastasis (osteolytic vs osteosclerotic).
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.
Interventions
- Genetic Biomolecular profile of bone metastases
Describe the biomolecular profile of bone metastases
Primary outcome measures
- Bone metastasis profiling [Time frame: up to 100 weeks]
- Fracture pathological profiling [Time frame: up to 100 weeks]
Secondary outcome measures (3)
- Comparison between the biomolecular profile of the mestastases and the primary tumor [Time frame: up to 100 weeks]
- Comparison between the biomolecular profiles of osteolytic and osteosclerotic metastases [Time frame: up to 100 weeks]
- Measuring PTH-rp (parathormone-related peptide) levels and the risk of pathologic facture [Time frame: Every 3-6 months]
Eligibility criteria
Inclusion criteria
- Age >= 18 years
- Patients with breast or lung or renal or gastroenteric tract or prostate with bone metastases
- Patients who knowingly express willingness to participate in the study after signing the written informed consent
Exclusion criteria
- None
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
Italy · 1 center
- IRCCS Azienda Ospedaliero-Universitaria di Bologna — Bologna
Identifiers
NCT: NCT06806462 · META_BONE · RC-2024-2790611