Solid TumoursNCT01998607
Survey of XGEVA® Presrcibers in Europe to Evaluate Their Knowledge of the Summary of Product Characteristics Pertaining to Osteonecrosis of the Jaw
An observational study of Solid Tumours and Bone Metastasis, run by Amgen.
Trial summary
Osteonecrosis of the Jaw (ONJ) is an adverse effect of antiresorptive therapy that is well-recognized in patients with advanced cancer. Detailed information regarding this risk is specified in the Summary of Product Characteristics (SPC). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Solid Tumours, Bone Metastasis
- What is being tested?
- Physician Survey
- How many people
- 420 participants
- Where
- No sites listed yet
- Study dates
- 4 Feb 2013to 15 May 2015
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Oncology specialists treating adult patients with bone metastases from solid tumours
Practicing oncology specialists who have treated at least 5 adult patients with bone metastases from solid tumours in the last quarter. Must have prescribed XGEVA® within the last 12 months. Must not have participated in a previous survey round
About this study
Official title: Survey of Oncology Practitioners Prescribing XGEVA® in Europe to Evaluate Their Knowledge of XGEVA® Summary of Product Characteristics Pertaining to Osteonecrosis of the Jaw
Osteonecrosis of the Jaw (ONJ) is an adverse effect of antiresorptive therapy that is well-recognized in patients with advanced cancer. Detailed information regarding this risk is specified in the Summary of Product Characteristics (SPC). The statements in the SPC are the most important mechanism for minimizing the risk for ONJ. The study objective is to measure the knowledge of oncology practitioners prescribing XGEVA® regarding the content pertaining to ONJ in the SPC after commercial availability.
Read the detailed description
This is a multiple cross-sectional survey study of practicing oncology practitioners prescribing XGEVA in Europe from across but not limited to the 5 largest European countries by population (including France, Germany, Italy, Spain and the U.K.) and 4 Nordic countries (Denmark, Finland, Norway and Sweden). The survey will be conducted in two rounds. The two survey rounds will be conducted 12 to 18 months and 24 to 30 months after XGEVA becomes commercially available in the participating countries. The initial contact and screening of potential participating oncology practitioners will continue until a total of 210 eligible and consenting oncology practitioners complete the survey per round. For the 5 largest European countries by population, it is intended that 30 oncology practitioners will be surveyed per country per survey round. If this sample size cannot be achieved, oncology practitioners from another country in that region will be surveyed to achieve a regional sample size of 150 per survey round. Oncology practitioners from the Nordic countries will be surveyed to achieve a regional sample size of 60 per survey round. For all countires, the number of surveys collected in each country in the second survey round will, where possible, equate to the number of surveys collected in each country in the first survey round.
- Conditions
- Solid Tumours, Bone Metastasis
- Being tested
- Physician Survey
- Keywords
- Solid tumours, Bone Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physician SurveyOther
Also called This is an observational study.
Eligible physicians will be contacted to perform the physician survey. A standardised online questionnaire will be used to collect information about the physician's awareness of the Summary of Product characteristics (SPC) pertaining to osteonecrosis of the jaw (ONJ) in the last 6-18 months.
| Study group | Role | What they receive |
|---|---|---|
| Round 1 | Survey of 210 oncologists 12 - 18 months after commercial availability of XGEVA® in the respective country Receives: Other: Physician Survey | |
| Round 2 | Survey of 210 oncologists 24 - 30 months after commercial availability of XGEVA® in the respective country Receives: Other: Physician Survey |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participating oncology practitioners prescribing XGEVA® who are aware of the SPC statements pertaining to ONJ (each question pertaining to a SPC statement will be assessed seperately at the end of each survey round)
Measured: 12 and 24 months after commercial availability of XGEVA® in the respective country
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2013 (estimated)
- Study start4 Feb 2013
- Primary completion15 May 2015
- Study completion15 May 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumoursStudies of the same condition, open and under way.
- More trials run by AmgenThe 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
- Cross-sectional
- Enrolment
- 420 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01998607
- Sponsor's protocol ID
- 20110102
- Status last verified
- Jan 2018
- First submitted
- 25 Nov 2013
- Last updated
- 9 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Survey of Oncology Practitioners Prescribing XGEVA® in Europe to Evaluate Their Knowledge of XGEVA® Summary of Product Characteristics Pertaining to Osteonecrosis of the Jaw
- ClinicalTrials.gov ID
- NCT01998607
- Acronym / sponsor ID
- 20110102
- Conditions
- Solid Tumours, Bone Metastasis
- Keywords
- Solid tumours, Bone Metastasis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 420 participants (estimated)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- 4 Feb 2013 (actual)
- Primary completion
- 15 May 2015 (actual)
- Study completion
- 15 May 2015 (actual)
- First posted
- 2 Dec 2013 (estimated)
- 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.
Osteonecrosis of the Jaw (ONJ) is an adverse effect of antiresorptive therapy that is well-recognized in patients with advanced cancer. Detailed information regarding this risk is specified in the Summary of Product Characteristics (SPC). The statements in the SPC are the most important mechanism for minimizing the risk for ONJ. The study objective is to measure the knowledge of oncology practitioners prescribing XGEVA® regarding the content pertaining to ONJ in the SPC after commercial availability.
Detailed description
This is a multiple cross-sectional survey study of practicing oncology practitioners prescribing XGEVA in Europe from across but not limited to the 5 largest European countries by population (including France, Germany, Italy, Spain and the U.K.) and 4 Nordic countries (Denmark, Finland, Norway and Sweden). The survey will be conducted in two rounds. The two survey rounds will be conducted 12 to 18 months and 24 to 30 months after XGEVA becomes commercially available in the participating countries. The initial contact and screening of potential participating oncology practitioners will continue until a total of 210 eligible and consenting oncology practitioners complete the survey per round. For the 5 largest European countries by population, it is intended that 30 oncology practitioners will be surveyed per country per survey round. If this sample size cannot be achieved, oncology practitioners from another country in that region will be surveyed to achieve a regional sample size of 150 per survey round. Oncology practitioners from the Nordic countries will be surveyed to achieve a regional sample size of 60 per survey round. For all countires, the number of surveys collected in each country in the second survey round will, where possible, equate to the number of surveys collected in each country in the first survey round.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Round 1 | – | Other: Physician SurveySurvey of 210 oncologists 12 - 18 months after commercial availability of XGEVA® in the respective country |
| Round 2 | – | Other: Physician SurveySurvey of 210 oncologists 24 - 30 months after commercial availability of XGEVA® in the respective country |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Oncology specialists treating adult patients with bone metastases from solid tumours
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 |
|---|---|---|
| Physician SurveyAlso: This is an observational study.Eligible physicians will be contacted to perform the physician survey. A standardised online questionnaire will be used to collect information about the physician's awareness of the Summary of Product characteristics (SPC) pertaining to osteonecrosis of the jaw (ONJ) in the last 6-18 months. | Other | Round 1, Round 2 |
Primary outcome
Proportion of participating oncology practitioners prescribing XGEVA® who are aware of the SPC statements pertaining to ONJ (each question pertaining to a SPC statement will be assessed seperately at the end of each survey round)
Time frame: 12 and 24 months after commercial availability of XGEVA® in the respective country
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 9 Jan 2018.
- AmgenTrials clinical trials websiteLink provided by the sponsor.
Related trials for Solid Tumours
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A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms
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A Safety and Efficacy Extension Study of Pertuzumab in Patients With Solid Tumors Previously Enrolled in a Hoffmann-La Roche-Sponsored Pertuzumab Clinical Trial
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IL-12 Genetically Engineered Myeloid Cells in Participants With Relapsed, Refractory Solid Tumors
Relapsed Solid Tumor Malignancies, Refractory Solid Tumor Malignancies
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Immune Checkpoint Inhibitor Toxicity Risk Prediction in Solid Tumors
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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.
MD study director
Amgen
Questions about this trial
What is this clinical trial studying?
An observational study of Solid Tumours and Bone Metastasis, run by Amgen.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Proportion of participating oncology practitioners prescribing XGEVA® who are aware of the SPC statements pertaining to ONJ (each question pertaining to a SPC statement will be assessed seperately at the end of each survey round) (time frame: 12 and 24 months after commercial availability of XGEVA® in the respective country). 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 9 Jan 2018.