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| Name | Class |
|---|---|
| Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company | INDUSTRY |
| Merck Sharp & Dohme LLC | INDUSTRY |
| Janssen-Cilag G.m.b.H | INDUSTRY |
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National, retro- and prospective, observational, multicenter clinical research platform to connect clinical and genomic data of patients with advanced (locally advanced, inoperable, or metastatic) solid tumors (excluding NSCLC, SCLC, and mesothelioma) with results from multi-gene next-generation sequencing (NGS) panels (>30 genes)
The AIO-BNHO CONNECT research platform is a clinic-genomic database collecting data on NGS results and corresponding clinical outcomes in patients with advanced solid tumors (excluding NSCLC, SCLC, and mesothelioma). Data of deceased patients will be included. The platform will provide insight into the current state of precision oncology in Germany by compiling real-world data encompassing a broad spectrum of care providers including but not limited to practice-based oncologists, community hospitals, and university hospitals. The platform also comprises a decentral tissue repository with clinically annotated tumor specimens retrieved within routine clinical care that can be used in future collaborative research projects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MIN Data Set | Patients who did not receive a targeted therapy based on NGS results (outside of a clinical trial) |
| |
| EXT Data Set | Patients who received a targeted therapy based on NGS results (outside of a clinical trial) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Minimal documentation | Other | Minimal data documentation only of patients without targeted therapy based on NGS results |
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| Measure | Description | Time Frame |
|---|---|---|
| Molecular tumorboard utilization | Proportion of patients who's case was discussed in a Molecular tumorboard | 3 years |
| Treatment reality after NGS analysis | Proportion of patients who received at least one targeted therapy based on NGS results, who exclusively received therapies other than targeted therapies based on NGS results or who did not receive any therapy | 3 years |
| NGS | Genomic alterations identified by multi-gene NGS panels | 3 years |
| Molecular tumorboard | Descriptive analysis of MTB-based therapy recommendations, their implementation rate and reasons for non-implementation | 3 years |
| Overall response rate | Overall response rate of targeted therapy based on NGS results | 3 years |
| Progression-free survival (PFS) | Progression-free survival from start of targeted therapy based on NGS results | 3 years |
| Overall survival | Overall survival from start of targeted therapy based on NGS results | 3 years |
| PFS ratio | PFS interval associated with targeted therapy(ies) administered after NGS analysis divided by the time to progression (TTP) interval associated with the last prior treatment(s) |
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Inclusion Criteria:
Exclusion Criteria:
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Adult patients with advanced (locally advanced, inoperable, or metastatic) solid tumors (excluding NSCLC, SCLC, and mesothelioma) ineligible for curative treatment and with results available from multi-gene next-generation sequencing (NGS) panels (>30 genes)
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Marc Fischer | Contact | +49 30-8145344 | 44 | marc.fischer@aio-studien-ggmbh.de |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Praxis für interdisziplinäre Onkologie & Hämatologie | Recruiting | Freiburg im Breisgau | Baden-Wurttemberg | 79110 | Germany |
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tissue samples collected in clinical routine
| Extended documentation | Other | Extended data documentation of patients with targeted therapy based on NGS results |
|
| 3 years |
| Medizinische Fakultät Mannheim der Universität Heidelberg | Not yet recruiting | Mannheim | Baden-Wurttemberg | 68167 | Germany |
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| Klinikum der Universität München | Not yet recruiting | München | Bavaria | 81377 | Germany |
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