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Trial Title:
AIO-BNHO Comprehensive Clinico-genomics Database Network - AIO-BNHO CONNECT
NCT ID:
NCT05701150
Condition:
Advanced Solid Tumor
Study type:
Observational [Patient Registry]
Overall status:
Recruiting
Study design:
Time perspective:
Other
Intervention:
Intervention type:
Other
Intervention name:
Minimal documentation
Description:
Minimal data documentation only of patients without targeted therapy based on NGS results
Arm group label:
MIN Data Set
Intervention type:
Other
Intervention name:
Extended documentation
Description:
Extended data documentation of patients with targeted therapy based on NGS results
Arm group label:
EXT Data Set
Arm group label:
MIN Data Set
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.
Criteria for eligibility:
Study pop:
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)
Sampling method:
Non-Probability Sample
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Praxis für interdisziplinäre Onkologie & Hämatologie
Address:
City:
Freiburg
Zip:
79110
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Matthias Zaiss, Dr. med.
Facility:
Name:
Medizinische Fakultät Mannheim der Universität Heidelberg
Address:
City:
Mannheim
Zip:
68167
Country:
Germany
Status:
Not yet recruiting
Contact:
Last name:
Sonja Loges, Prof. Dr. Dr. med.
Phone:
+49 621 383
Phone ext:
1757
Email:
Sonja.Loges@medma.uni-heidelberg.de
Facility:
Name:
Klinikum der Universität München
Address:
City:
München
Zip:
81377
Country:
Germany
Status:
Not yet recruiting
Contact:
Last name:
Benedikt Westphalen, Dr. med.
Phone:
+49 89 4400
Phone ext:
75250
Email:
christoph_benedikt.westphalen@med.uni-muenchen.de
Start date:
December 8, 2022
Completion date:
December 2025
Lead sponsor:
Agency:
AIO-Studien-gGmbH
Agency class:
Other
Collaborator:
Agency:
Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company
Agency class:
Industry
Collaborator:
Agency:
Merck Sharp & Dohme LLC
Agency class:
Industry
Collaborator:
Agency:
Janssen-Cilag G.m.b.H
Agency class:
Industry
Source:
AIO-Studien-gGmbH
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05701150
