Ignite Creation Date:
2024-05-19 @ 5:34 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06411015
Status:
COMPLETED
Last Update Posted:
2024-05-13
First Post:
2024-05-08
Brief Title:
Prognostic Evaluation Prediction Model Survival Spinal Epidural Metastases
Sponsor:
Radboud University Medical Center
Organization:
Radboud University Medical Center
Study Overview
Official Title:
Prognostic Evaluation of Prediction Model Survival Spinal Epidural Metastases
Status:
COMPLETED
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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 Harrels 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
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 Harrels 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None