Pathological Fracture in Potentially Unstable Spinal Metastases of Breast Cancer

NCT03365973 | Unknown

• 1 other identifier: RJ2017NO173
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Spinal Metastases; Breast Cancer

Keywords

Pathological Fracture; Indeterminate Instability; Spinal Metastases; Breast Cancer

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (5)

• 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

Study Arms (1)

Spinal metastases of breast cancer

Patients with potentially unstable spinal metastases of breast cancer

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

A total of 120 patients with potentially unstable spinal metastases of breast cancer will be enrolled

You may qualify if:

• Age 18-65 years, female
• Had a histological confirmation of breast cancer, including all pathological types
• Had a histological or radiological confirmation of spinal metastases from breast cancer
• SINS 7-12

You may not qualify if:

• Prior prophylactic stabilization surgery to the spine at current level of interest
• Patients with other malignancies except breast cancer
• Misdiagnosis of spinal metastases from breast cancer confirmed by pathological examination
• Patients without undergoing follow-up on schedule
• Withdraw from the study for any reason

Sponsors & Collaborators

• Ruijin Hospital: lead

Study Sites (1)

Ruijin Hospital Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, 200025, China

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms; Fractures, Spontaneous

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Fractures, Bone; Wounds and Injuries

Study Officials

• Yuhui Shen, Ph.D., M.D.

  Ruijin Hospital

  PRINCIPAL INVESTIGATOR

• Weibin Zhang, Ph.D., M.D.

  Ruijin Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yuhui Shen, Ph.D., M.D.

CONTACT

+8613918209875; yuhuiss@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 26, 2017
• First Posted: December 8, 2017
• Study Start: December 15, 2017
• Primary Completion: December 15, 2022
• Study Completion: December 15, 2022
• Last Updated: October 8, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)