Spinal MetastasesNCT03365973
Pathological Fracture in Potentially Unstable Spinal Metastases of Breast Cancer
An observational study of Spinal Metastases and Breast Cancer, run by Ruijin Hospital at 1 site in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Spinal Metastases, Breast Cancer
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 15 Dec 2017to 15 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: A total of 120 patients with potentially unstable spinal metastases of breast cancer will be enrolled
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Ruijin Hospital Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200025
Yuhui Shen, Ph.D., M.D., +8613918209875, yuhuiss@163.com
Yuhui Shen, Ph.D., M.D.
About this study
Official title: A Pilot Study of Pathological Fracture Progression and Related Risk Factors for Patients With Potentially Unstable Spinal Metastases of Breast Cancer
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.
Read the detailed description
Considering the concept of spinal instability remains important in the clinical decision-making process for patients with spine metastases, the Spine Oncology Study Group (SOSG) devised an 18-point SINS, which proved reliable and has been widely used in clinical practice. Scores of 0-6, 7-12, 13-18 are considered stable, potentially unstable, and unstable, respectively. Lesions with a low SINS (score 0-6) do not requires surgical interventions, whereas a high SINS (score 13-18) predicts the need for surgical stabilization to restore spinal stability. However, treatment strategy of intermediate SINS (score 7-12) lesions remains ambiguous owing to the uncertainty of spinal stability. With the duration of spinal metastases, some potentially unstable lesions turn to be stable while some turn to be unstable, and several factors such as tumor involvement for vertebral body, radiotherapy may account for different outcomes. Owing to the relatively weaker growth and invasion ability of breast cancer cells compared to other solid tumors such as lung cancer and liver cancer, patients with breast cancer and spinal metastases have longer life expectancy. Reasonable and prompt local surgical intervention to restore spinal stability can achieve pain relief and better quality of life effectively. Moreover, most spinal metastases from breast cancer show lytic or mixed lytic-blastic bone lesions, which exacerbates the spinal stability and results in pathological fracture. Thus, investigators focus on patients which having spinal metastases from breast cancer and an intermediate SINS (score 7-12) to explore the rate of pathological fracture and relevant risk factors. This study will help spine surgeon to identify who could benefit from a prophylactic stabilization procedure with high risk of pathological fracture and when is the best timing of surgery.
- Conditions
- Spinal Metastases, Breast Cancer
- Keywords
- Pathological Fracture, Indeterminate Instability, Spinal Metastases, Breast Cancer
- Medical subject headings
- Breast Neoplasms, Fractures, Spontaneous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Spinal metastases of breast cancer | Patients with potentially unstable spinal metastases of breast cancer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of the pathological fracture of spine
Pathological fracture will be detected using Magnetic Resonance Imaging (MRI)
Measured: 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
Measured: 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
Measured: 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
Measured: 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)
The Spine Instability Neoplastic Score (SINS) is a comprehensive classification system that can aid in predicting spine stability of neoplastic lesions. The 18-point SINS includes global spinal location of the tumor (score 0-3), type and presence of pain (score 0-3), bone lesion quality (score 0-2), spinal alignment (score 0-4), extent of vertebral body collapse (score 0-3), and posterolateral spinal element involvement (score 0-3). As the SINS increases, the spine stability of neoplastic lesions turns to be worse
Measured: 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
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2017
- Study start15 Dec 2017
- Primary completion15 Dec 2022 (estimated)
- Study completion15 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal MetastasesStudies of the same condition, open and under way.
- More trials run by Ruijin HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yuhui Shen, Ruijin Hospital
- Investigators
- Yuhui Shen, Ph.D., M.D., Principal investigator, Ruijin HospitalWeibin Zhang, Ph.D., M.D., Principal investigator, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03365973
- Sponsor's protocol ID
- RJ2017NO173
- Status last verified
- Oct 2020
- First submitted
- 26 Nov 2017
- Last updated
- 8 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Pathological Fracture Progression and Related Risk Factors for Patients With Potentially Unstable Spinal Metastases of Breast Cancer
- ClinicalTrials.gov ID
- NCT03365973
- Acronym / sponsor ID
- RJ2017NO173
- Conditions
- Spinal Metastases, Breast Cancer
- Keywords
- Pathological Fracture, Indeterminate Instability, Spinal Metastases, Breast Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Study start
- 15 Dec 2017 (actual)
- Primary completion
- 15 Dec 2022 (estimated)
- Study completion
- 15 Dec 2022 (estimated)
- First posted
- 8 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Considering the concept of spinal instability remains important in the clinical decision-making process for patients with spine metastases, the Spine Oncology Study Group (SOSG) devised an 18-point SINS, which proved reliable and has been widely used in clinical practice. Scores of 0-6, 7-12, 13-18 are considered stable, potentially unstable, and unstable, respectively. Lesions with a low SINS (score 0-6) do not requires surgical interventions, whereas a high SINS (score 13-18) predicts the need for surgical stabilization to restore spinal stability. However, treatment strategy of intermediate SINS (score 7-12) lesions remains ambiguous owing to the uncertainty of spinal stability. With the duration of spinal metastases, some potentially unstable lesions turn to be stable while some turn to be unstable, and several factors such as tumor involvement for vertebral body, radiotherapy may account for different outcomes. Owing to the relatively weaker growth and invasion ability of breast cancer cells compared to other solid tumors such as lung cancer and liver cancer, patients with breast cancer and spinal metastases have longer life expectancy. Reasonable and prompt local surgical intervention to restore spinal stability can achieve pain relief and better quality of life effectively. Moreover, most spinal metastases from breast cancer show lytic or mixed lytic-blastic bone lesions, which exacerbates the spinal stability and results in pathological fracture. Thus, investigators focus on patients which having spinal metastases from breast cancer and an intermediate SINS (score 7-12) to explore the rate of pathological fracture and relevant risk factors. This study will help spine surgeon to identify who could benefit from a prophylactic stabilization procedure with high risk of pathological fracture and when is the best timing of surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Spinal metastases of breast cancer | – | –Patients with potentially unstable spinal metastases of breast cancer |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- A total of 120 patients with potentially unstable spinal metastases of breast cancer will be enrolled
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Rate of the pathological fracture of spine
Time frame: 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
Pathological fracture will be detected using Magnetic Resonance Imaging (MRI)
5 secondary outcomes
Quality of life outcomes measured by EORTC QLQ-C30 questionnaire
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yuhui Shen, Ph.D., M.D. principal investigator
Ruijin Hospital
Weibin Zhang, Ph.D., M.D. principal investigator
Ruijin Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spinal Metastases and Breast Cancer, run by Ruijin Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yuhui Shen, Ph.D., M.D. (+8613918209875, yuhuiss@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of the pathological fracture of spine (time frame: 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2020.