Evaluation of treatments for bone metastases
Prospective Evaluation of Interventional Studies on Bone Metastases - the PRESENT Cohort
UMC Utrecht · NCT02356497
This study is testing how well standard treatments work for people with bone metastases to help improve their care and quality of life.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 2500 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | UMC Utrecht (other) |
| Drugs / interventions | radiation |
| Locations | 1 site (Utrecht, Utrecht) |
| Trial ID | NCT02356497 on ClinicalTrials.gov |
What this trial studies
The PRESENT cohort is designed to evaluate patients with bone metastases receiving standard care while collecting clinical and patient-reported outcomes. Patients provide informed consent to participate in the cohort and may be randomly selected for future randomized controlled trials (RCTs) within the cohort. This approach allows for the identification of factors influencing treatment response and the development of survival models. The study aims to improve treatment selection and quality of life for patients suffering from painful bone metastases.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years with histologically confirmed malignancy and metastatic bone disease undergoing radiotherapy.
Not a fit: Patients with a life expectancy of less than one week or those who are mentally incompetent may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment strategies and better quality of life for patients with bone metastases.
How similar studies have performed: Other studies have shown success with similar cohort designs, indicating potential for meaningful advancements in treatment evaluation.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Histologic proof of malignancy; * Radiographic or histologic proof of metastatic bone disease; * Undergoing radiotherapy; * Age \> 18 years; * Informed consent - at least - for use of routinely collected clinical data. Exclusion Criteria: * Mentally incompetent patients; * Life expectancy \< 1 week indicated by the treating physician.
Where this trial is running
Utrecht, Utrecht
- University Medical Center Utrecht — Utrecht, Utrecht, Netherlands (RECRUITING)
Study contacts
- Principal investigator: Helena M. Verkooijen, MD, PhD — UMC Utrecht
- Study coordinator: Roxanne Gal, PhD
- Email: r.gal@umcutrecht.nl
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Bone Metastases, Bone metastases, Metastatic bone disease, Multi-trial facility