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
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.
|Condition or disease|
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||2500 participants|
|Target Follow-Up Duration:||3 Years|
|Official Title:||Prospective Evaluation of Interventional Studies on Bone Metastases - the PRESENT Cohort|
|Actual Study Start Date :||June 2013|
|Estimated Primary Completion Date :||December 2022|
|Estimated Study Completion Date :||December 2023|
- Pain response [ Time Frame: at 2, 4, 6, 8 weeks, 3 and 6 months, then every 6 months ]
- 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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02356497
|Contact: Joanne M. van der Velden, MD||+31(0)firstname.lastname@example.org|
|Contact: Helena M. Verkooijen, MD, PhDemail@example.com|
|Principal Investigator:||Helena M. Verkooijen, MD, PhD||UMC Utrecht|