A Pilot Study of Pathological Fracture Progression and Related Risk Factors for Patients With Potentially Unstable Spinal Metastases of Breast Cancer
Sponsor study identifier
observational
120
1 country
1
Study Start
December 15, 2017
Actual (reported)Primary Completion
December 15, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 15, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
The purpose of this study is to identify potential risk factors for and determine the rate of pathological fracture for patients which having spine metastases from breast cancer and be defined as potentially unstable (SINS 7-12) according to the Spinal Instability Neoplastic Score (SINS). The investigators' analysis will provide robust data about the development of spinal instability and help identify the optimal timing of local surgery treatment.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 15, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 26, 2017
Actual (reported)December 8, 2017
Actual (reported)December 15, 2017
Actual (reported)December 15, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 15, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Rate of the pathological fracture of spine
Pathological fracture will be detected using Magnetic Resonance Imaging (MRI)
First diagnosis of spinal metastases, every 3 months in the first year after diagnosis, every 6 months after one year after diagnosis. Up to 2 years
Quality of life outcomes measured by EORTC QLQ-C30 questionnaire
First diagnosis of spinal metastases, every 3 months in the first year after diagnosis, every 6 months after one year after diagnosis. Up to 2 years
Quality of life outcomes measured by EORTC QLQ-BM22 questionnaire
First diagnosis of spinal metastases, every 3 months in the first year after diagnosis, every 6 months after one year after diagnosis. Up to 2 years
Pain and functional outcome data measured by Brief Pain Inventory (BPI) questionnaire
First diagnosis of spinal metastases, every 3 months in the first year after diagnosis, every 6 months after one year after diagnosis. Up to 2 years
Spinal stability measured by Spinal Instability Neoplastic Score (SINS)
First diagnosis of spinal metastases, every 3 months in the first year after diagnosis, every 6 months after one year after diagnosis. Up to 2 years
Neurologic outcome measured by Frankel grading system
First diagnosis of spinal metastases, every 3 months in the first year after diagnosis, every 6 months after one year after diagnosis. Up to 2 years
Patients with potentially unstable spinal metastases of breast cancer
A total of 120 patients with potentially unstable spinal metastases of breast cancer will be enrolled
Ruijin Hospital Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200025, China
Yuhui Shen, Ph.D., M.D.
Ruijin Hospital
Weibin Zhang, Ph.D., M.D.
Ruijin Hospital
First Submitted
November 26, 2017
First Posted
December 8, 2017
Study Start
December 15, 2017
Actual (reported)Primary Completion
December 15, 2022
Estimated (date passed)Contact the study team to confirm eligibility.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 15, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
October 8, 2020
Record last verified: 2020-10
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