NCT02356497 Prospective Evaluation of Interventional Studies on Bone Metastases - the PRESENT Cohort
| NCT ID | NCT02356497 |
| Status | Recruiting |
| Phase | — |
| Sponsor | UMC Utrecht |
| Condition | Bone Metastases |
| Study Type | OBSERVATIONAL |
| Enrollment | 2,500 participants |
| Start Date | 2013-06 |
| Primary Completion | 2035-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 2,500 participants in total. It began in 2013-06 with a primary completion date of 2035-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Bone metastases are frequent distant manifestations of cancer, with pain as a common and devastating consequence. The primary treatment for painful bone metastases, external beam radiation therapy, is moderately effective: about 60% of patients who undergo conventional radiotherapy experience (partial) pain relief. Several factors associated with treatment failure have been identified, but no attempts have been made to collapse these factors into a clinically useful prediction tool to predict treatment response. In addition, to aid in therapy selection based on expected survival time, development of survival models is essential. Finally, we need innovative treatments as alternatives or additive to standard treatment options to improve quality of life (QoL). For these reasons, we set up the PRESENT cohort study, recruiting patients at the departments of radiation oncology and orthopedic surgery. We aim to provide detailed information about clinical data, create an infrastructure for efficient, fast and pragmatic evaluation and implementation of innovative interventions, as well as development of accurate new prediction tools.
Eligibility 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.
Contact & Investigator
Roxanne Gal, PhD
✉ r.gal@umcutrecht.nlHelena M. Verkooijen, MD, PhD
PRINCIPAL INVESTIGATOR
UMC Utrecht
Frequently Asked Questions
Who can join the NCT02356497 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Bone Metastases. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT02356497 currently recruiting?
Yes, NCT02356497 is actively recruiting participants. Contact the research team at r.gal@umcutrecht.nl for enrollment information.
Where is the NCT02356497 trial being conducted?
This trial is being conducted at Utrecht, Netherlands.
Who is sponsoring the NCT02356497 clinical trial?
NCT02356497 is sponsored by UMC Utrecht. The principal investigator is Helena M. Verkooijen, MD, PhD at UMC Utrecht. The trial plans to enroll 2,500 participants.