Biomolecular Markers of Bone Metastasis

NCT06806462 | Recruiting

• 2 other identifiers: META_BONERC-2024-2790611
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

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?

Conditions

Bone Metastasis

Keywords

bone; metastasis; biomolecular profile

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Comparison between the biomolecular profile of the mestastases and the primary tumor

  up to 100 weeks

• Comparison between the biomolecular profiles of osteolytic and osteosclerotic metastases

  up to 100 weeks

• Measuring PTH-rp (parathormone-related peptide) levels and the risk of pathologic facture

  Every 3-6 months

Study Arms (1)

Bone metastasis

OTHER

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

Genetic: Biomolecular profile of bone metastases

Interventions

Biomolecular profile of bone metastases GENETIC

Describe the biomolecular profile of bone metastases

Bone metastasis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• None

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead

Study Sites (1)

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, Bologna, 40138, Italy

RECRUITING

MeSH Terms

Conditions

Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Andrea Sambri, MD

  IRCCS Azienda Ospedaliero-Universitaria di Bologna

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Andrea Sambri, MD

CONTACT

0512142680; andrea.sambri@aosp.bo.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 28, 2024
• First Posted: February 4, 2025
• Study Start: September 17, 2024
• Primary Completion (Estimated): June 17, 2026
• Study Completion (Estimated): September 17, 2026
• Last Updated: February 4, 2025

Record last verified: 2024-10

Locations

IT (1)