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

March 18, 2026 updated by: Helena M Verkooijen, UMC Utrecht

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.

Study Overview

Status

Recruiting

Conditions

Detailed Description

The PRESENT cohort is set up according to the 'cohort multiple Randomised Controlled Trial' design. The basis of this design is a prospective cohort of patients with bone metastases, receiving care as usual, who give informed consent for cohort participation. At the UMC Utrecht, patients are furthermore asked for informed consent to be randomized in future RCTs conducted within the cohort. Patients are informed that they will be offered the experimental intervention if they are randomly selected. They are also informed that they otherwise might serve as controls without being notified and that their data can be used in a trial context. For each patient in the cohort, clinical and patient-reported outcomes are captured at baseline and at regular intervals during follow-up. Within this cohort, multiple RCTs can be conducted. For this purpose, eligible patients who have provided the consent required for them to participate in an RCT within the cohort are identified. From this subcohort, a random selection of patients will be invited to undergo the experimental intervention. Eligible participants who were not randomly selected receive standard care, are not informed about the experimental intervention and serve as controls. Outcomes in this control group are compared with the outcomes of those who were offered the experimental intervention, in order to estimate the effect of the experimental intervention versus usual care. Within the cohort, the same process can be repeated for trials of other interventions.

Study Type

Observational

Enrollment (Estimated)

2500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pain response
Time Frame: at 2, 4, 6, 8 weeks, 3 and 6 months, then every 6 months
at 2, 4, 6, 8 weeks, 3 and 6 months, then every 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Health-related Quality of Life
Time Frame: at 2, 4, 6, 8 weeks and 3 months
at 2, 4, 6, 8 weeks and 3 months
Toxicity according to CTCAE version 4
Time Frame: up to 3 months
Grade 3 and 4 side effects occurring during or up to 3 months after radiotherapy will be registered according to the Common Terminology Criteria for Adverse Events (CTCAE version 4). The following side effects will be registered: Nausea; Vomiting; Diarrhoea; Pain flare.
up to 3 months
Readmission
Time Frame: up to 3 years
Reintervention (reirradiation, surgery, other); Development of neurological symptoms; Development of pathologic fracture
up to 3 years
Survival
Time Frame: up to 3 years
Survival of participating patients will be recorded using the follow up questionnaires (returned by family members) or are derived from the Municipal Personal Records Database (in Dutch: Gemeentelijke Basisadministratie, GBA).
up to 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

UMC Utrecht

Investigators

  • Principal Investigator: Helena M. Verkooijen, MD, PhD, UMC Utrecht

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2013

Primary Completion (Estimated)

December 1, 2035

Study Completion (Estimated)

December 1, 2035

Study Registration Dates

First Submitted

February 1, 2015

First Submitted That Met QC Criteria

February 1, 2015

First Posted (Estimated)

February 5, 2015

Study Record Updates

Last Update Posted (Actual)

March 19, 2026

Last Update Submitted That Met QC Criteria

March 18, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NL49273.041.14

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Current enrolment approaches 2000 patients. Investigators are encouraged to request data after consulting the study team.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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