Biomolecular Markers of Bone Metastasis

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?

Study Overview

• Status: Recruiting
• Conditions: Bone Metastasis
• Intervention / Treatment: Genetic: Biomolecular profile of bone metastases

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.

• Study Type: Interventional
• Enrollment (Estimated): 160
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Andrea Sambri, MD; Phone Number: 0512142680; Email: andrea.sambri@aosp.bo.it

Study Locations

• Italy
  • Bologna, Italy, 40138
    • Recruiting
    • IRCCS Azienda Ospedaliero-Universitaria di Bologna
    • Contact: Andrea Sambri, MD; Phone Number: 0512142680; Email: andrea.sambri@aosp.bo.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Bone metastasis; Patients with breast or lung or renal or gastroenteric tract or prostate carcinomas with bone metastases	Genetic: Biomolecular profile of bone metastases; Describe the biomolecular profile of bone metastases

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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; RANK/RANKL; OPG; PTHLH; IL-1/6/7/8/11,; TNF-alfa	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison between the biomolecular profile of the mestastases and the primary tumor	Trascriptional profile of: RANK/RANKL,; OPG; PTHLH; IL-1/6/7/8/11; TNF-alfa	up to 100 weeks
Comparison between the biomolecular profiles of osteolytic and osteosclerotic metastases	Trascriptional profile of: RANK/RANKL,; OPG; PTHLH; IL-1/6/7/8/11; TNF-alfa	up to 100 weeks
Measuring PTH-rp (parathormone-related peptide) levels and the risk of pathologic facture	Dosage of PTHrp	Every 3-6 months

Collaborators and Investigators

• Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
• Investigators: Principal Investigator: Andrea Sambri, MD, IRCCS Azienda Ospedaliero-Universitaria di Bologna

Study record dates

Study Major Dates

• Study Start (Actual): September 17, 2024
• Primary Completion (Estimated): June 17, 2026
• Study Completion (Estimated): September 17, 2026

Study Registration Dates

• First Submitted: November 28, 2024
• First Submitted That Met QC Criteria: January 28, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 28, 2025
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: bone; metastasis; biomolecular profile
• Additional Relevant MeSH Terms: Bone Diseases; Musculoskeletal Diseases; Pathologic Processes; Neoplasms by Site; Neoplasms; Hematologic Diseases; Neoplastic Processes; Neoplasm Metastasis; Bone Neoplasms; Bone Marrow Diseases
• Other Study ID Numbers: META_BONE; RC-2024-2790611 (Other Grant/Funding Number: Italian Ministry of Health)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No