Biomolecular Markers of Bone Metastasis

NCT ID: NCT06806462

Last Updated: 2025-02-04

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 160 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-17
• Study Completion Date: 2026-09-17

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.

Conditions

Bone Metastasis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Bone metastasis

Patients with breast or lung or renal or gastroenteric tract or prostate carcinomas with bone metastases

Group Type: OTHER

Biomolecular profile of bone metastases

Intervention Type: GENETIC

Describe the biomolecular profile of bone metastases

Interventions

Biomolecular profile of bone metastases

Describe the biomolecular profile of bone metastases

Intervention Type: GENETIC

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

IRCCS Azienda Ospedaliero-Universitaria di Bologna

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Andrea Sambri, MD

Role: PRINCIPAL_INVESTIGATOR

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Locations

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, Bologna, Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Andrea Sambri, MD

Role: CONTACT

andrea.sambri@aosp.bo.it

0512142680

Facility Contacts

Andrea Sambri, MD

Role: primary

andrea.sambri@aosp.bo.it

0512142680

Other Identifiers

RC-2024-2790611

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

META_BONE

Identifier Type: -

Identifier Source: org_study_id