AIO-BNHO Comprehensive Clinico-genomics Database Network - AIO-BNHO CONNECT

Study Overview
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Brief Summary
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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)

Detailed Description
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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.

Official Title
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AIO-BNHO Comprehensive Clinico-genomics Database Network - AIO-BNHO CONNECT

Conditions
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Advanced Solid Tumor

Intervention / Treatment
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* Other: Minimal documentation
* Other: Extended documentation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of advanced (i.e., locally advanced, inoperable, or metastatic) solid tumor, ineligible for curative surgery and/or curative systemic therapy Available results of commercial or non-commercial RNA- and/or DNA-based multi-gene NGS panels with >30 genes analyzed; for non-commercial panels a list of all tested genes and multiple gene biomarkers (e.g., tumor mutational burden (TMB), microsatellite status) must be provided Age ≥ 18 years Signed and dated informed consent form (not applicable for inclusion of deceased patients) Exclusion Criteria: Diagnosis of NSCLC/SCLC (C34) or mesothelioma (C45) NGS results older than two years at the date of patient inclusion

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| MIN Data Set<br>Patients who did not receive a targeted therapy based on NGS results (outside of a clinical trial) | Other: Minimal documentation<br>* Minimal data documentation only of patients without targeted therapy based on NGS results<br>Other: Extended documentation<br>* Extended data documentation of patients with targeted therapy based on NGS results<br>|
| EXT Data Set<br>Patients who received a targeted therapy based on NGS results (outside of a clinical trial) | Other: Extended documentation<br>* Extended data documentation of patients with targeted therapy based on NGS results<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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) | 3 years |