Predictive Cancer ModelNCT06411015
Prognostic Evaluation Prediction Model Survival Spinal Epidural Metastases
An observational study of Predictive Cancer Model, run by Radboud University Medical Center at 1 site in Netherlands.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Predictive Cancer Model
- How many people
- 428 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Jan 2021to 1 May 2024
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: adult with a known or unknown malignancy presenting with symptomatic spinal metastasis
Who may be able to join
- patients with spinal spinal metastasis
- symptomatic
- adult
- informed consent
Who cannot join
- not understanding informed consent
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Radboud University Nijmegen Medical Center
Nijmegen, Gelderland, 6500 HB
About this study
Official title: 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
Read the 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.
- Conditions
- Predictive Cancer Model
What is being measured
The primary outcome is the main question the study is designed to answer.
survival after diagnosis of spinal metastasis
survival after diagnosis of spinal metastasis
Measured: minimal 6 months after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2024
- Study start1 Jan 2021
- Primary completion1 Jan 2024
- Study completion1 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Predictive Cancer ModelStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe 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
- Other
- Time perspective
- Prospective
- Enrolment
- 428 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06411015
- Sponsor's protocol ID
- Radboudumcnch001
- Status last verified
- May 2024
- First submitted
- 8 May 2024
- Last updated
- 13 May 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognostic Evaluation of Prediction Model Survival Spinal Epidural Metastases
- ClinicalTrials.gov ID
- NCT06411015
- Acronym / sponsor ID
- Radboudumcnch001
- Conditions
- Predictive Cancer Model
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 428 participants (actual)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 1 Jan 2024 (actual)
- Study completion
- 1 May 2024 (actual)
- First posted
- 13 May 2024 (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.
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 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 design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- adult with a known or unknown malignancy presenting with symptomatic spinal metastasis
Key inclusion criteria (4 listed)
- patients with spinal spinal metastasis
- symptomatic
- adult
- informed consent
Key exclusion criteria (1 listed)
- not understanding informed consent
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
survival after diagnosis of spinal metastasis
Time frame: minimal 6 months after inclusion
survival after diagnosis of spinal metastasis
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Predictive Cancer Model, run by Radboud University Medical Center at 1 site in Netherlands.
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 1 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: finished, as of the sponsor's last update on 13 May 2024. 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 Netherlands. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
survival after diagnosis of spinal metastasis (time frame: minimal 6 months after inclusion). 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 13 May 2024.