Clinical trial NCT06806462: Biomolecular Markers of Bone Metastasis
Official title: Biomolecular Markers of Bone Metastasis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Bone Metastasis
Keywords: bone
metastasis
biomolecular profile
Lead sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Sponsor class: OTHER
First posted: 2025-02-04
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: 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.

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

Primary outcomes:
measure: Bone metastasis profiling
timeFrame: up to 100 weeks
measure: Fracture pathological profiling
timeFrame: up to 100 weeks
Secondary outcomes:
measure: Comparison between the biomolecular profile of the mestastases and the primary tumor
timeFrame: up to 100 weeks
measure: Comparison between the biomolecular profiles of osteolytic and osteosclerotic metastases
timeFrame: up to 100 weeks
measure: Measuring PTH-rp (parathormone-related peptide) levels and the risk of pathologic facture
timeFrame: Every 3-6 months
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Study officials:
affiliation: IRCCS Azienda Ospedaliero-Universitaria di Bologna
name: Andrea Sambri, MD
role: PRINCIPAL_INVESTIGATOR
References: