Autor: |
Crippa, Alessio, Laere, Bram De, Discacciati, Andrea, Larsson, Berit, Connor, Jason T., Gabriel, Erin E., Thellenberg, Camilla, Jänes, Elin, Enblad, Gunilla, Ullen, Anders, Hjälm-Eriksson, Marie, Oldenburg, Jan, Ost, Piet, Lindberg, Johan, Eklund, Martin, Grönberg, Henrik |
Rok vydání: |
2020 |
DOI: |
10.6084/m9.figshare.12569321.v1 |
Popis: |
Additional file 1: Supplementary Figure 1. Patients pathway. Patients in ProBio may end up in an observational arm where standard-of-care (SOC) is administered. This may have been the result of low or undetectable ctDNA (Pathway 1, 10 & 14), technical failure during liquid biopsy profiling (Pathway 2, 11 & 15) or identification of the MSI or hypermutator (Pathway 3). When biomarker signature can be inferred, the trajectory of the new patient depends whether particular biomarker signature-treatments combinations have graduated. If none are available, the patient will be randomized either to the control group (SOC) or one of the active treatments (Pathway 4 & 5). Upon first randomisation and progressive disease, the allocated patients remain in their respective arm for re-randomisation (Pathway 8 & 12). However, as patients might be unfit or unwilling to continue the trial after their first randomisation, both patient and treating physician might chose to discontinue the patient and exit the trial (Pathway 9 & 13). If a newly entered patient has a biomarker signature for which a graduated biomarker signature-therapy combination is available, the patient will enter a confirmatory trial pathway, which uses fixed randomisation between control and graduating treatment (Pathway 6-7). Finally, upon progressive disease after the second randomisation (Pathway 16 & 17), or after randomisation within the confirmatory trial testing the graduated biomarker signature-therapy combination (Pathway 18), all patients will discontinue and exit the ProBio trial. |
Databáze: |
OpenAIRE |
Externí odkaz: |
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