AIO-BNHO Comprehensive Clinico-genomics Database Network - AIO-BNHO CONNECT
- Conditions
- Advanced Solid Tumor
- Interventions
- Other: Minimal documentationOther: Extended documentation
- Registration Number
- NCT05701150
- Lead Sponsor
- AIO-Studien-gGmbH
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 3000
- 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)
- Diagnosis of NSCLC/SCLC (C34) or mesothelioma (C45)
- NGS results older than two years at the date of patient inclusion
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description MIN Data Set Minimal documentation Patients who did not receive a targeted therapy based on NGS results (outside of a clinical trial) MIN Data Set Extended documentation Patients who did not receive a targeted therapy based on NGS results (outside of a clinical trial) EXT Data Set Extended documentation Patients who received a targeted therapy based on NGS results (outside of a clinical trial)
- Primary Outcome Measures
Name Time Method Molecular tumorboard utilization 3 years Proportion of patients who's case was discussed in a Molecular tumorboard
Treatment reality after NGS analysis 3 years 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
Progression-free survival (PFS) 3 years Progression-free survival from start of targeted therapy based on NGS results
Overall survival 3 years Overall survival from start of targeted therapy based on NGS results
PFS ratio 3 years 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)
NGS 3 years Genomic alterations identified by multi-gene NGS panels
Molecular tumorboard 3 years Descriptive analysis of MTB-based therapy recommendations, their implementation rate and reasons for non-implementation
Overall response rate 3 years Overall response rate of targeted therapy based on NGS results
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (3)
Praxis für interdisziplinäre Onkologie & Hämatologie
🇩🇪Freiburg, Baden-Württemberg, Germany
Medizinische Fakultät Mannheim der Universität Heidelberg
🇩🇪Mannheim, Baden-Württemberg, Germany
Klinikum der Universität München
🇩🇪München, Bayern, Germany