Pediatric Cancer
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: ? Diagnosis or suspicion of a relapsed/refractory cancer or ? Diagnosis of a non-cancer / hematological diagnosis if the patient is discussed in the WPSZ tumor board ? Treatment in a hospital of the West German Pediatric Trial Center (WPSZ). ? Written informed consent from parents or legal guardians and/or from the patient if appropriate according to age and status of psycho-intellectual development. ? Enrollment in the PRO/QoL study warrants specific consent at the designated part of the informed consent form for the registry.
Exclusion criteria
Exclusion criteria: None
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Prospective collection of key characteristics of all patients with relapsed/refractory cancer which are treated in a hospital of the West German Pediatric Trial Center (WPSZ) with the aims: ? To establish a comprehensive collection of clinical data of all patients with relapsed/refractory cancer from the WPSZ. ? To allow analysis of the clinical data, performed molecular tumor diagnostics and incidence of relapse/refractory diseases by entities and by molecular changes. ? To provide a data base to estimate the number of available patients in preparation of biomarker driven trials and/or phase I/II trials. ? To provide a data base for allocation of patients into clinical trials with a focus on biomarker driven trials and/or phase I/II trial. ? To use collected data for discussion of current patients in the WPSZ tumor board. ? To facilitate assessment of molecular targets identified in molecular tumor diagnostics. ? To support identification of suitable targeted therapies if no clinical trial is available. ? To facilitate exchange of experience with novel therapies in- and outside clinical trials. ? To contribute / assemble data with the other GPOH phase I/II networks and ongoing and future national and international cooperations, e.g. with the German Children’s Cancer Registry, the LESS consortium for evaluation of late effects, the ITCC consortium, the SIOP group, the Dutch DCOG, the American COG, the PCDC consortium, and other partners. ? To assess patients’ and families’ quality of life (QoL) and psychosocial burden by patient and parent reported outcome measures (PROM) as well as patient-reported experience measures (PREMs) (PRO/QoL study). ? To integrate a virtual platform for remote visits or/and joint visits with trial site and home clinic (video tool) and assess its usefulness (PRO/QoL study). ? To facilitate combined analysis of clinical data and information about diagnostics, treatment, and QoL. | — |
Secondary
| Measure | Time frame |
|---|---|
| see above | — |
Countries
Germany
Contacts
Universitätsklinikum Köln