Connecting clinical and genomic data for patients with advanced solid tumors
AIO-BNHO Comprehensive Clinico-genomics Database Network - AIO-BNHO CONNECT
AIO-Studien-gGmbH · NCT05701150
This study is gathering and analyzing health and genetic information from patients with advanced solid tumors to improve cancer treatment in Germany.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 3000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | AIO-Studien-gGmbH (other) |
| Locations | 3 sites (Freiburg im Breisgau, Baden-Wurttemberg and 2 other locations) |
| Trial ID | NCT05701150 on ClinicalTrials.gov |
What this trial studies
The AIO-BNHO CONNECT platform is a national, observational research initiative that collects and analyzes clinical and genomic data from patients with advanced solid tumors, excluding certain lung cancers and mesothelioma. It aims to compile real-world data from various healthcare providers, including community hospitals and university hospitals, to enhance understanding of precision oncology in Germany. The platform includes a decentralized tissue repository for tumor specimens, which can be utilized in future research projects. Both retrospective and prospective data will be gathered, including information from deceased patients.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older diagnosed with advanced solid tumors that are inoperable or not eligible for curative systemic therapy.
Not a fit: Patients with non-small cell lung cancer, small cell lung cancer, or mesothelioma will not benefit from this study.
Why it matters
Potential benefit: If successful, this initiative could significantly improve the understanding of treatment outcomes and genomic profiles in advanced solid tumors, leading to better personalized treatment strategies.
How similar studies have performed: Other studies utilizing similar approaches of integrating clinical and genomic data have shown promise, indicating potential for success in this novel initiative.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Freiburg im Breisgau, Baden-Wurttemberg and 2 other locations
- Praxis für interdisziplinäre Onkologie & Hämatologie — Freiburg im Breisgau, Baden-Wurttemberg, Germany (RECRUITING)
- Medizinische Fakultät Mannheim der Universität Heidelberg — Mannheim, Baden-Wurttemberg, Germany (NOT_YET_RECRUITING)
- Klinikum der Universität München — München, Bavaria, Germany (NOT_YET_RECRUITING)
Study contacts
- Study coordinator: Marc Fischer
- Email: marc.fischer@aio-studien-ggmbh.de
- Phone: +49 30-8145344
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Advanced Solid Tumor