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

NCT02356497 | Recruiting DMC

• 1 other identifier: NL49273.041.14
• Study Type: observational
• Target: 2,500
• Locations: 1 country
• Sites: 1

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.

Conditions

Bone Metastases

Keywords

Bone metastases; Metastatic bone disease; Multi-trial facility

Outcome Measures

Primary Outcomes (1)

• Pain response

  at 2, 4, 6, 8 weeks, 3 and 6 months, then every 6 months

Secondary Outcomes (4)

• Health-related Quality of Life

  at 2, 4, 6, 8 weeks and 3 months

• Toxicity according to CTCAE version 4

  up to 3 months

• Readmission

  up to 3 years

• Survival

  up to 3 years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients with bone metastases undergoing radiotherapy will be asked to participate in this cohort study.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• UMC Utrecht: lead

Study Sites (1)

University Medical Center Utrecht

Utrecht, Utrecht, 3508 GA, Netherlands

RECRUITING

Related Links

• Related Info

MeSH Terms

Conditions

Bone Diseases

Condition Hierarchy (Ancestors)

Musculoskeletal Diseases

Study Officials

• Helena M. Verkooijen, MD, PhD

  UMC Utrecht

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Roxanne Gal, PhD

CONTACT

r.gal@umcutrecht.nl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. dr.

Study Record Dates

• First Submitted: February 1, 2015
• First Posted: February 5, 2015
• Study Start: June 1, 2013
• Primary Completion (Estimated): December 1, 2035
• Study Completion (Estimated): December 1, 2035
• Last Updated: March 19, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share

Locations

NL (1)