Lead Investigator: Jonas Saal, University Hospital Bonn
Title of Proposal Research: Establishing a risk score for Skeletal Related Events (SRE) in patients with cancer
Vivli Data Request: 10091
Funding Source: University Hospital Bonn
Potential Conflicts of Interest: None
Summary of the Proposed Research:
Skeletal-related events (SREs), such as fractures, spinal cord compression, and severe bone pain, have serious implications for cancer patients, significantly reducing their quality of life and complicating treatment. These events can lead to hospitalization, loss of mobility, and increased need for medical interventions, impacting both the patient’s physical and emotional well-being. Given the severe consequences of SREs, it’s crucial to identify which patients are at higher risk to ensure early intervention and targeted treatment strategies.
Key serum-based markers found in the blood, like calcium and alkaline phosphatase (ALP, it is a protein in the blood and high levels can suggest a bone disorder), are valuable for predicting the risk of skeletal-related events in cancer patients. These markers provide insights into bone metabolism and can help identify individuals at risk for bone complications, such as those with bone metastases (where the cancer has spread to the bones) or other conditions affecting bone integrity. Despite the potential of these biomarkers, there’s a lack of clear guidelines on when to use treatments like bisphosphonates (a class of drugs that can help to strengthen bones and reduce the risk of bone fractures) or denosumab (a specific drug that helps to strengthen the bones and prevent fractures for some types of cancer) that can help to strengthen bones and reduce the risk of bones breaking based on blood serum levels. A well-constructed risk score could help bridge this gap by providing a data-driven approach to identify high-risk patients and inform treatment decisions, ultimately leading to improved patient outcomes and more effective cancer care.
We are requesting access to clinical trial data to establish a risk score for predicting skeletal-related events (SRE) in cancer patients, with a particular focus on serum-based laboratory biomarkers. The goal is to identify blood-based indicators that correlate with bone complications like fractures and severe pain, which can significantly impact patient quality of life. By analyzing data from clinical trials, we aim to discover serum biomarkers that are predictive of these events. This information will enable us to develop a risk score that can help clinicians detect high-risk patients early, adjust treatments to minimize bone-related issues, and ultimately enhance patient outcomes. Many serum-based laboratory markers, including calcium and alkaline phosphatase, are known to correlate with bone metastases and SRE. The aim of this project is the development of a cost-effective, easy-to-implement tool for clinical practice.
Requested Studies:
A Multinational, Randomised, Double-blind, Placebo-controlled, Phase III Efficacy and Safety Study of Darolutamide (ODM-201) in Men With High-risk Non-metastatic Castration-resistant Prostate Cancer
Data Contributor: Bayer
Study ID: NCT02200614
Sponsor ID: 17712
A Randomized, Double-blind, Comparative Study of Abiraterone Acetate Plus Low-Dose Prednisone Plus Androgen Deprivation Therapy (ADT) Versus ADT Alone in Newly Diagnosed Subjects With High-Risk, Metastatic Hormone-naive Prostate Cancer (mHNPC)
Data Contributor: Johnson & Johnson
Study ID: NCT01715285
Sponsor ID: CR100900
A Randomized, Phase III Study of Standard Dosing Versus Longer Dosing Interval of Zoledronic Acid in Metastatic Cancer
Data Contributor: Project Data Sphere
Study ID: NCT00869206
Sponsor ID: CALGB-70604
A Randomized Double-Blind, Placebo-Controlled Phase III Study of Early Versus Standard Zoledronic Acid to Prevent Skeletal Related Events in Men With Prostate Cancer Metastatic to Bone
Data Contributor: Project Data Sphere
Study ID: NCT00079001
Sponsor ID: CALGB-90202
A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate AMG 162 in the Treatment of Bone Loss in Subjects Undergoing Androgen-Deprivation Therapy for Non-metastatic Prostate Cancer
Data Contributor: Project Data Sphere
Study ID: NCT00089674
Sponsor ID: 20040138
A Randomized, Double-Blind, Multicenter Study of Denosumab Compared With Zoledronic Acid (Zometa®) in the Treatment of Bone Metastases in Men With Hormone-Refractory Prostate Cancer
Data Contributor: Project Data Sphere
Study ID: NCT00321620
Sponsor ID: 20050103
Randomized Phase III Trial to Evaluate Radiopharmaceuticals and Zoledronic Acid in the Palliation of Osteoblastic Metastases From Lung, Breast, and Prostate Cancer
Data Contributor: Project Data Sphere
Study ID: NCT00365105
Sponsor ID: RTOG 0517
A Multicenter, Randomized, Double Blind Study Comparing the Efficacy and Safety of Aflibercept Versus Placebo Administered Every 3 Weeks in Patients Treated With Docetaxel/ Prednisone for Metastatic Androgen-independent Prostate Cancer
Data Contributor: Sanofi
Study ID: NCT00519285
Sponsor ID: EFC6546