Vertebral MetastasisCVODMetsVertNCT05985434
Prospective Observational Study on Vertebral Metastasis
An observational study of Vertebral Metastasis, run by Istituto Ortopedico Rizzoli at 1 site in Italy.
Trial summary
Perspective observational cohort study in which the data relating to patients affected by one or more vertebral metastases or by vertebral localization of hemolifoproliferative malact and surgical treatment candidates will be collected, which will be recruited at the Complex Structure of Spine Surgery for Oncological… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vertebral Metastasis
- What is being tested?
- Surgical treatment
- Type of treatment
- Surgery or procedure
- How many people
- 191 participants
- Where
- 1 siteItaly
- Study dates
- 21 Aug 2018to 1 Dec 2023
- 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: Patients affected by vertebral metastasis eligible for surgical treatment
Who may be able to join
- Patients who are candidates for surgery at the level of the spine at the SC of Spine Surgery, for: or vertebral metastases or or vertebral localizations from hemolymphoproliferative diseases
- Patients aged ≥ 18 years
- Patients giving written informed consent to the study
Who cannot join
- Patients with malignant or benign vertebral tumors
- Patients suffering from vertebral metastases or vertebral localizations from hemolymphoproliferative diseases for which there are no indications for surgical treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Observational Study on Patients Treated for Vertebral Metastasis and Vertebral Localizations of Lymphoproliferative Disease: Impact of the Treatment on the Quality of Life.
Perspective observational cohort study in which the data relating to patients affected by one or more vertebral metastases or by vertebral localization of hemolifoproliferative malact and surgical treatment candidates will be collected, which will be recruited at the Complex Structure of Spine Surgery for Oncological and Degenerative Rizzoli Orthopedic Institute starting from the date of approval of the same study.
Patients of both sexes and aged 18 years or older will be included. Patients with primary (benign or malignant) tumors of the vertebrae and patients unable to consent to the study will be excluded from the study.
Read more
For each patient, in addition to the demographic data, preoperative information will be collected: type of tumor, involved vertebral levels, presence of pathological fracture, presence of visceral metastases, presence and number of other bone metastases, neurological picture according to Frankel's scale, evaluated pain according to the Visual Analogue Scale (VAS), functional status according to Karnofsky, EuroQoL-5D and SF-36 questionnaires on the quality of life; information related to the intervention itself: access, type of surgical treatment, possible preoperative embolization; intraoperative complications; information at discharge: postoperative complications, pain, neurological picture, functional status; follow-up data: pain, neurological picture, functional status, SF-36 questionnaire, late complications, local recurrence; systemic progression of the disease.
Follow-up checks will be performed at 3 months, 6 months, 12 months, 18 months, 24 and 36 months. The timing of the controls and the examinations requested by the patients will be those of normal clinical practice.
Primary endpoint is the change in quality of life (measured by scores EQ-5D and SF-36) and pain (measured using the VAS score) following surgery compared to pre-operative values.
Read the detailed description
STUDY DESIGN Analytical Prospective Longitudinal cohort Not checked
RATIONALE OF THE STUDY The improvement of the systemic control of oncological diseases achieved in recent years has led to a considerable increase in patient survival; it was associated with a parallel increase in the onset of symptomatic vertebral metastases.
Such metastases are often associated with pain, mechanical instability of the spine, and even possible neurological deficits, which negatively affect the patient's quality of life and indirectly also on his survival.
The treatment of these metastases is defined by a multidisciplinary approach; surgery is indicated in the presence of mechanical instability, signs of neurological compression, intractable pain, progression of disease during systemic treatment.
The indication and the type of intervention are defined following a reference algorithm (A. Gasbarrini, M. Cappuccio, L. Mirabile, S. Bandiera, S. Terzi, G. Barbanti Bròdano, S. Boriani.) Spinal Metastases: treatment evaluation algorithm Eur Eur Med Pharmacol Sci 2004; 8: 265-274), in collaboration with the team of specialists involved.
Within the multidisciplinary team it is usually the Oncologist who provides an estimate of the prognosis quoad vitam, based on the general status of the patient and the residual therapeutic possibilities.
The goal of surgery is the local control of the disease and the improvement of the patient's quality of life.
Although there are works in the literature that demonstrate the effectiveness of surgical treatment in vertebral metastases, there are few prospective studies in which, in addition to survival, the improvement in the quality of life after the intervention is evaluated, and the improvement over time is maintained.
DESCRIPTION OF THE STUDY The study is monocentric, of a prospective observational type, with a single arm.
The study will collect data relating to patients affected by one or more vertebral metastases or by vertebral localization of hemolymphoproliferative disease candidates for surgical treatment, which will be recruited at the Complex Structure of Spine Surgery for Oncological and Degenerative Address of the Rizzoli Orthopedic Institute starting from date of approval of the study itself.
Patients of both sexes and aged 18 years or older will be included
DATA COLLECTION
For each patient will be collected, in addition to demographic data:
- preoperative information: type of tumor, vertebral levels involved, presence of pathological fracture, presence of visceral metastases, presence and number of other bone metastases, functional status according to Karnofsky (Annex 1), neurological picture according to Frankel's scale (Annex 2) , pain assessed according to the Visual Analogue Scale (VAS), EuroQoL-5D and SF-36 questionnaires on the quality of life;
- information on the intervention: access, type of surgical treatment, possible preoperative embolization; intraoperative complications;
- information at discharge: postoperative complications, pain, neurological picture, functional status;
- follow-up data: pain (VAS scale), neurological picture (according to the Frankel scale), functional status according to Karnofsky, EuroQoL-5D and SF-36 questionnaires on quality of life, late complications, local recurrence; systemic progression of the disease.
The clinical data necessary for the research will be extracted from the patient's medical record and from its source documents.
A specific data collection form will be used to collect the clinical information and the results of the analysis foreseen by the study.
For each patient included in the study, the data collection form (Case Report Form - CRF) will be compiled.
Follow-up checks will be performed, as per clinical practice, at 3 months, 6 months, 12 months, 18 months, 24 months and 36 months.
- Conditions
- Vertebral Metastasis
- Being tested
- Surgical treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgical treatmentProcedure or surgery
decompression with or without stabilization; stabilization only; debulking; en bloc resection
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain evaluation
Visual Analogue Scale (VAS) patient-administered questionnaire
Measured: At baseline (day 0)
Pain evaluation
Visual Analogue Scale (VAS) patient-administered questionnaire
Measured: At 3 months follow up
Pain evaluation
Visual Analogue Scale (VAS) patient-administered questionnaire
Measured: At 6 months follow up
Pain evaluation
Visual Analogue Scale (VAS) patient-administered questionnaire
Measured: At 12 months follow up
Pain evaluation
Visual Analogue Scale (VAS) patient-administered questionnaire
Measured: At 18 months follow up
Pain evaluation
Visual Analogue Scale (VAS) patient-administered questionnaire
Measured: At 24 months follow up
Pain evaluation
Visual Analogue Scale (VAS) patient-administered questionnaire
Measured: At 36 months follow up
Quality of life evaluation
EuroQoL- 5D (EQ-5D) patient-administered questionnaire
Measured: At baseline (day 0)
Quality of life evaluation
EuroQoL- 5D (EQ-5D) patient-administered questionnaire
Measured: At 3 months follow up
Quality of life evaluation
EuroQoL- 5D (EQ-5D) patient-administered questionnaire
Measured: At 6 months follow up
Quality of life evaluation
EuroQoL- 5D (EQ-5D) patient-administered questionnaire
Measured: At 12 months follow up
Quality of life evaluation
EuroQoL- 5D (EQ-5D) patient-administered questionnaire
Measured: At 18 months follow up
Quality of life evaluation
EuroQoL- 5D (EQ-5D) patient-administered questionnaire
Measured: At 24 months follow up
Quality of life evaluation
EuroQoL- 5D (EQ-5D) patient-administered questionnaire
Measured: At 36 months follow up
Health survey
Short Form Health Survey 36 (SF-36) patient-administered questionnaire
Measured: At baseline (day 0)
Health survey
Short Form Health Survey 36 (SF-36) patient-administered questionnaire
Measured: At 3 months follow up
Health survey
Short Form Health Survey 36 (SF-36) patient-administered questionnaire
Measured: At 6 months follow up
Health survey
Short Form Health Survey 36 (SF-36) patient-administered questionnaire
Measured: At 12 months follow up
Health survey
Short Form Health Survey 36 (SF-36) patient-administered questionnaire
Measured: At 18 months follow up
Health survey
Short Form Health Survey 36 (SF-36) patient-administered questionnaire
Measured: At 24 months follow up
Health survey
Short Form Health Survey 36 (SF-36) patient-administered questionnaire
Measured: At 36 months follow up
Secondary outcomes (10)
Prognostic factor- 1
Surgery-related adverse events collected by SAVES-v.2 system
Measured: 3 months follow up
Prognostic factor- 2
Survival rate
Measured: 3 months follow up
Prognostic factor- 1
Surgery-related adverse events collected by SAVES-v.2 system
Measured: 6 months follow up
Prognostic factor- 2
Survival rate
Measured: 6 months follow up
Prognostic factor- 1
Surgery-related adverse events collected by SAVES-v.2 system
Measured: 12 months follow up
Prognostic factor- 2
Survival rate
Measured: 12 months follow up
Prognostic factor- 1
Surgery-related adverse events collected by SAVES-v.2 system
Measured: 24 months follow up
Prognostic factor- 2
Survival rate
Measured: 24 months follow up
Prognostic factor- 1
Surgery-related adverse events collected by SAVES-v.2 system
Measured: 36 months follow up
Prognostic factor- 2
Survival rate
Measured: 36 months follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2023
- Study start21 Aug 2018
- Primary completion1 Dec 2022
- Study completion1 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vertebral MetastasisStudies of the same condition, open and under way.
- 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
- 191 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto Ortopedico Rizzoli
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Silvia Terzi, MD, Principal investigator, Istituto Ortopedico Rizzoli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05985434
- Sponsor's protocol ID
- 0009120
- Acronym
- CVODMetsVert
- Status last verified
- Jan 2024
- First submitted
- 8 Jan 2019
- Last updated
- 3 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Observational Study on Patients Treated for Vertebral Metastasis and Vertebral Localizations of Lymphoproliferative Disease: Impact of the Treatment on the Quality of Life.
- ClinicalTrials.gov ID
- NCT05985434
- Acronym / sponsor ID
- CVODMetsVert / 0009120
- Conditions
- Vertebral Metastasis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 191 participants (actual)
- Lead sponsor
- Istituto Ortopedico RizzoliUniversity, hospital or other
- Study start
- 21 Aug 2018 (actual)
- Primary completion
- 1 Dec 2022 (actual)
- Study completion
- 1 Dec 2023 (actual)
- First posted
- 14 Aug 2023 (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.
Perspective observational cohort study in which the data relating to patients affected by one or more vertebral metastases or by vertebral localization of hemolifoproliferative malact and surgical treatment candidates will be collected, which will be recruited at the Complex Structure of Spine Surgery for Oncological and Degenerative Rizzoli Orthopedic Institute starting from the date of approval of the same study.
Patients of both sexes and aged 18 years or older will be included. Patients with primary (benign or malignant) tumors of the vertebrae and patients unable to consent to the study will be excluded from the study.
For each patient, in addition to the demographic data, preoperative information will be collected: type of tumor, involved vertebral levels, presence of pathological fracture, presence of visceral metastases, presence and number of other bone metastases, neurological picture according to Frankel's scale, evaluated pain according to the Visual Analogue Scale (VAS), functional status according to Karnofsky, EuroQoL-5D and SF-36 questionnaires on the quality of life; information related to the intervention itself: access, type of surgical treatment, possible preoperative embolization; intraoperative complications; information at discharge: postoperative complications, pain, neurological picture, functional status; follow-up data: pain, neurological picture, functional status, SF-36 questionnaire, late complications, local recurrence; systemic progression of the disease.
Follow-up checks will be performed at 3 months, 6 months, 12 months, 18 months, 24 and 36 months. The timing of the controls and the examinations requested by the patients will be those of normal clinical practice.
Primary endpoint is the change in quality of life (measured by scores EQ-5D and SF-36) and pain (measured using the VAS score) following surgery compared to pre-operative values.
Detailed description
STUDY DESIGN Analytical Prospective Longitudinal cohort Not checked
RATIONALE OF THE STUDY The improvement of the systemic control of oncological diseases achieved in recent years has led to a considerable increase in patient survival; it was associated with a parallel increase in the onset of symptomatic vertebral metastases.
Such metastases are often associated with pain, mechanical instability of the spine, and even possible neurological deficits, which negatively affect the patient's quality of life and indirectly also on his survival.
The treatment of these metastases is defined by a multidisciplinary approach; surgery is indicated in the presence of mechanical instability, signs of neurological compression, intractable pain, progression of disease during systemic treatment.
The indication and the type of intervention are defined following a reference algorithm (A. Gasbarrini, M. Cappuccio, L. Mirabile, S. Bandiera, S. Terzi, G. Barbanti Bròdano, S. Boriani.) Spinal Metastases: treatment evaluation algorithm Eur Eur Med Pharmacol Sci 2004; 8: 265-274), in collaboration with the team of specialists involved.
Within the multidisciplinary team it is usually the Oncologist who provides an estimate of the prognosis quoad vitam, based on the general status of the patient and the residual therapeutic possibilities.
The goal of surgery is the local control of the disease and the improvement of the patient's quality of life.
Although there are works in the literature that demonstrate the effectiveness of surgical treatment in vertebral metastases, there are few prospective studies in which, in addition to survival, the improvement in the quality of life after the intervention is evaluated, and the improvement over time is maintained.
DESCRIPTION OF THE STUDY The study is monocentric, of a prospective observational type, with a single arm.
The study will collect data relating to patients affected by one or more vertebral metastases or by vertebral localization of hemolymphoproliferative disease candidates for surgical treatment, which will be recruited at the Complex Structure of Spine Surgery for Oncological and Degenerative Address of the Rizzoli Orthopedic Institute starting from date of approval of the study itself.
Patients of both sexes and aged 18 years or older will be included
DATA COLLECTION
For each patient will be collected, in addition to demographic data:
- preoperative information: type of tumor, vertebral levels involved, presence of pathological fracture, presence of visceral metastases, presence and number of other bone metastases, functional status according to Karnofsky (Annex 1), neurological picture according to Frankel's scale (Annex 2) , pain assessed according to the Visual Analogue Scale (VAS), EuroQoL-5D and SF-36 questionnaires on the quality of life;
- information on the intervention: access, type of surgical treatment, possible preoperative embolization; intraoperative complications;
- information at discharge: postoperative complications, pain, neurological picture, functional status;
- follow-up data: pain (VAS scale), neurological picture (according to the Frankel scale), functional status according to Karnofsky, EuroQoL-5D and SF-36 questionnaires on quality of life, late complications, local recurrence; systemic progression of the disease.
The clinical data necessary for the research will be extracted from the patient's medical record and from its source documents.
A specific data collection form will be used to collect the clinical information and the results of the analysis foreseen by the study.
For each patient included in the study, the data collection form (Case Report Form - CRF) will be compiled.
Follow-up checks will be performed, as per clinical practice, at 3 months, 6 months, 12 months, 18 months, 24 months and 36 months.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients affected by vertebral metastasis eligible for surgical treatment
Key inclusion criteria (3 listed)
- Patients who are candidates for surgery at the level of the spine at the SC of Spine Surgery, for: or vertebral metastases or or vertebral localizations from hemolymphoproliferative diseases
- Patients aged ≥ 18 years
- Patients giving written informed consent to the study
Key exclusion criteria (2 listed)
- Patients with malignant or benign vertebral tumors
- Patients suffering from vertebral metastases or vertebral localizations from hemolymphoproliferative diseases for which there are no indications for surgical treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Surgical treatmentdecompression with or without stabilization; stabilization only; debulking; en bloc resection | Procedure or surgery | – |
Primary outcome
Pain evaluation
Time frame: At baseline (day 0)
Visual Analogue Scale (VAS) patient-administered questionnaire
Pain evaluation
Time frame: At 3 months follow up
Visual Analogue Scale (VAS) patient-administered questionnaire
Pain evaluation
Time frame: At 6 months follow up
Visual Analogue Scale (VAS) patient-administered questionnaire
Pain evaluation
Time frame: At 12 months follow up
Visual Analogue Scale (VAS) patient-administered questionnaire
Pain evaluation
Time frame: At 18 months follow up
Visual Analogue Scale (VAS) patient-administered questionnaire
Pain evaluation
Time frame: At 24 months follow up
Visual Analogue Scale (VAS) patient-administered questionnaire
Pain evaluation
Time frame: At 36 months follow up
Visual Analogue Scale (VAS) patient-administered questionnaire
Quality of life evaluation
Time frame: At baseline (day 0)
EuroQoL- 5D (EQ-5D) patient-administered questionnaire
Quality of life evaluation
Time frame: At 3 months follow up
EuroQoL- 5D (EQ-5D) patient-administered questionnaire
Quality of life evaluation
Time frame: At 6 months follow up
EuroQoL- 5D (EQ-5D) patient-administered questionnaire
Quality of life evaluation
Time frame: At 12 months follow up
EuroQoL- 5D (EQ-5D) patient-administered questionnaire
Quality of life evaluation
Time frame: At 18 months follow up
EuroQoL- 5D (EQ-5D) patient-administered questionnaire
Quality of life evaluation
Time frame: At 24 months follow up
EuroQoL- 5D (EQ-5D) patient-administered questionnaire
Quality of life evaluation
Time frame: At 36 months follow up
EuroQoL- 5D (EQ-5D) patient-administered questionnaire
Health survey
Time frame: At baseline (day 0)
Short Form Health Survey 36 (SF-36) patient-administered questionnaire
Health survey
Time frame: At 3 months follow up
Short Form Health Survey 36 (SF-36) patient-administered questionnaire
Health survey
Time frame: At 6 months follow up
Short Form Health Survey 36 (SF-36) patient-administered questionnaire
Health survey
Time frame: At 12 months follow up
Short Form Health Survey 36 (SF-36) patient-administered questionnaire
Health survey
Time frame: At 18 months follow up
Short Form Health Survey 36 (SF-36) patient-administered questionnaire
Health survey
Time frame: At 24 months follow up
Short Form Health Survey 36 (SF-36) patient-administered questionnaire
Health survey
Time frame: At 36 months follow up
Short Form Health Survey 36 (SF-36) patient-administered questionnaire
10 secondary outcomes
Prognostic factor- 1
Time frame: 3 months follow up
Prognostic factor- 2
Time frame: 3 months follow up
Prognostic factor- 1
Time frame: 6 months follow up
Prognostic factor- 2
Time frame: 6 months follow up
Prognostic factor- 1
Time frame: 12 months follow up
Prognostic factor- 2
Time frame: 12 months follow up
Prognostic factor- 1
Time frame: 24 months follow up
Prognostic factor- 2
Time frame: 24 months follow up
Prognostic factor- 1
Time frame: 36 months follow up
Prognostic factor- 2
Time frame: 36 months follow up
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 3 Jan 2024.
- Individual participant dataSharing planned: Undecided
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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.
Silvia Terzi, MD principal investigator
Istituto Ortopedico Rizzoli
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 Vertebral Metastasis, run by Istituto Ortopedico Rizzoli at 1 site in Italy.
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 3 inclusion and 2 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 3 Jan 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 Italy. 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?
Pain evaluation (time frame: At baseline (day 0)). The study lists 21 primary outcomes in all. 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 3 Jan 2024.