Prognostic Evaluation Prediction Model Survival Spinal Epidural Metastases

Prognostic Evaluation of Prediction Model Survival Spinal Epidural Metastases

Patients with symptomatic spinal metatstasis will be prosepectively included in a database after theu signes informed consent. Minimally six months after inclusion the survival status is analyzed. These are correlated with factors that are used in an earlier develloped prediction model

Study Overview

• Status: Completed
• Conditions: Predictive Cancer Model

Detailed Description

The prediction model is web-based and used five parameters: Karnofsky performance score (KPS) (in case of sudden (<24 hours) deterioration the score was used just before the deterioration), the curative intention to treat the primary, the spinal level of the symptomatic tumor, histopathology of the metastasis, and sex. These parameters will be recorded in addition to baseline characteristics. The date of presentation will be recorded. Four months after inclusion of the last patient survival status of all patients will scored. If applicable the date of death will be noted.

Patients are eligible if they suffer from a symptomatic epidural spinal metastatic lesion warranting therapy, either radiation therapy or a combination of surgery and radiation therapy. The nature of the lesion should be verified by pathological examination. In case of an active primary that has recently been diagnosed (less than one year previous to presentation of spinal lesion), the metastatic lesion is considered to be related to this primary. However, if the patient has more than one primary in the history, pathological verification of the tissue is obligatory.

After the patients provided informed consent of using their data for scientific use including the publication of the results, they will be included. The data will be collected, and electronically and anonymized stored. Patients will be included during three successive years. It is estimated that approximately 450 patients can be included. Two centers will participate, Radboud University Medical Center and Haaglanden Medical Center.

Statistical analysis The Cox model will be validated as described earlier 4, first graphically the predictive ability will be plotted, whereas next it will be quantitatively expressed as Harrel's c-index and the Royston -Sauerbrei D-statistic, Rd2. The calibration slope is also calculated. A sample of one third of all patients will be used for validation purpose. If needed the model is adapted. Then the validation is performed using the data of all patients.

• Study Type: Observational
• Enrollment (Actual): 428

Contacts and Locations

Study Locations

• Netherlands
  • Gelderland
    • Nijmegen, Gelderland, Netherlands, 6500 HB
      • Radboud University Nijmegen Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

adult with a known or unknown malignancy presenting with symptomatic spinal metastasis

Description

Inclusion Criteria:

• patients with spinal spinal metastasis
• symptomatic
• adult
• informed consent

Exclusion Criteria:

• not understanding informed consent

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
survival after diagnosis of spinal metastasis	survival after diagnosis of spinal metastasis	minimal 6 months after inclusion

Collaborators and Investigators

• Sponsor: Radboud University Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2021
• Primary Completion (Actual): January 1, 2024
• Study Completion (Actual): May 1, 2024

Study Registration Dates

• First Submitted: May 8, 2024
• First Submitted That Met QC Criteria: May 8, 2024
• First Posted (Actual): May 13, 2024

Study Record Updates

• Last Update Posted (Actual): May 13, 2024
• Last Update Submitted That Met QC Criteria: May 8, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Neoplastic Processes; Neoplasm Metastasis
• Other Study ID Numbers: Radboudumcnch001