AIO-BNHO Comprehensive Clinico-genomics Database Network - AIO-BNHO CONNECT
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Minimal documentation, Extended documentation.
- Who it may be relevant to
- Registry conditions: Advanced Solid Tumor. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- Other Minimal documentation
Minimal data documentation only of patients without targeted therapy based on NGS results - Other Extended documentation
Extended data documentation of patients with targeted therapy based on NGS results
Primary outcome measures
- Molecular tumorboard utilization [Time frame: 3 years]
- Treatment reality after NGS analysis [Time frame: 3 years]
- NGS [Time frame: 3 years]
- Molecular tumorboard [Time frame: 3 years]
- Overall response rate [Time frame: 3 years]
- Progression-free survival (PFS) [Time frame: 3 years]
- Overall survival [Time frame: 3 years]
- PFS ratio [Time frame: 3 years]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Germany · 3 centers
- Praxis für interdisziplinäre Onkologie & Hämatologie — Freiburg im Breisgau
- Medizinische Fakultät Mannheim der Universität Heidelberg — Mannheim
- Klinikum der Universität München — München
Identifiers
NCT: NCT05701150 · AIO-TF-0122