Clinical trial NCT05701150: AIO-BNHO Comprehensive Clinico-genomics Database Network - AIO-BNHO CONNECT
Official title: AIO-BNHO Comprehensive Clinico-genomics Database Network - AIO-BNHO CONNECT
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Advanced Solid Tumor
Lead sponsor: AIO-Studien-gGmbH
Sponsor class: OTHER
Collaborators: name: Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company
name: Merck Sharp & Dohme LLC
name: Janssen-Cilag G.m.b.H
First posted: 2023-01-27
Enrollment: 3000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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)

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.

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

Primary outcomes:
measure: Molecular tumorboard utilization
timeFrame: 3 years
measure: Treatment reality after NGS analysis
timeFrame: 3 years
measure: NGS
timeFrame: 3 years
measure: Molecular tumorboard
timeFrame: 3 years
measure: Overall response rate
timeFrame: 3 years
measure: Progression-free survival (PFS)
timeFrame: 3 years
measure: Overall survival
timeFrame: 3 years
measure: PFS ratio
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Freiburg
country: Germany
facility: Praxis für interdisziplinäre Onkologie & Hämatologie
state: Baden-Württemberg
city: Mannheim
country: Germany
facility: Medizinische Fakultät Mannheim der Universität Heidelberg
state: Baden-Württemberg
city: München
country: Germany
facility: Klinikum der Universität München
state: Bayern
Study officials:
References: