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

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ClinicalTrials.gov Identifier: NCT02356497
Recruitment Status : Recruiting
First Posted : February 5, 2015
Last Update Posted : September 25, 2019
Sponsor:
Information provided by (Responsible Party):
Helena M Verkooijen, UMC Utrecht

Tracking Information
First Submitted Date February 1, 2015
First Posted Date February 5, 2015
Last Update Posted Date September 25, 2019
Actual Study Start Date June 2013
Estimated Primary Completion Date December 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 1, 2015)
Pain response [ Time Frame: at 2, 4, 6, 8 weeks, 3 and 6 months, then every 6 months ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: July 13, 2018)
  • Health-related Quality of Life [ Time Frame: 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.
  • Readmission [ Time Frame: up to 3 years ]
    Reintervention (reirradiation, surgery, other); Development of neurological symptoms; Development of pathologic fracture
  • 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).
Original Secondary Outcome Measures
 (submitted: February 1, 2015)
  • Health-related Quality of Life [ Time Frame: at 2, 4, 6, 8 weeks and 3 months ]
  • Toxicity [ 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.
  • Readmission [ Time Frame: up to 3 years ]
    Reintervention (reirradiation, surgery, other); Development of neurological symptoms; Development of pathologic fracture
  • 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).
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Prospective Evaluation of Interventional Studies on Bone Metastases - the PRESENT Cohort
Official Title Prospective Evaluation of Interventional Studies on Bone Metastases - the PRESENT Cohort
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.

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 [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 3 Years
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population All patients with bone metastases undergoing radiotherapy will be asked to participate in this cohort study.
Condition Bone Metastases
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: September 24, 2019)
2500
Original Estimated Enrollment
 (submitted: February 1, 2015)
1470
Estimated Study Completion Date December 2023
Estimated Primary Completion Date December 2022   (Final data collection date for primary outcome measure)
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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Joanne M. van der Velden, MD +31(0)887550803 j.m.vandervelden@umcutrecht.nl
Contact: Helena M. Verkooijen, MD, PhD h.m.verkooijen@umcutrecht.nl
Listed Location Countries Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number NCT02356497
Other Study ID Numbers NL49273.041.14
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Current Responsible Party Helena M Verkooijen, UMC Utrecht
Original Responsible Party M. van Vulpen, UMC Utrecht, Prof. dr.
Current Study Sponsor UMC Utrecht
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators
Principal Investigator: Helena M. Verkooijen, MD, PhD UMC Utrecht
PRS Account UMC Utrecht
Verification Date September 2019