RecruitingNCT02356497

Prospective Evaluation of Interventional Studies on Bone Metastases - the PRESENT Cohort


Sponsor

UMC Utrecht

Enrollment

2,500 participants

Start Date

Jun 1, 2013

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria5

  • 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 Criteria2

  • Mentally incompetent patients;
  • Life expectancy < 1 week indicated by the treating physician.

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Locations(1)

University Medical Center Utrecht

Utrecht, Utrecht, Netherlands

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NCT02356497


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