AIO-BNHO Comprehensive Clinico-genomics Database Network - AIO-BNHO CONNECT

AIO-Studien

Status: Enrolling

Conditions: Advanced Solid Tumor

Treatments: Other: Extended documentation; Other: Minimal documentation

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT05701150

AIO-TF-0122

Details and patient eligibility

About

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)

Full 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.

Enrollment: 3,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

3,000 participants in 2 patient groups

MIN Data Set

Description:

Patients who did not receive a targeted therapy based on NGS results (outside of a clinical trial)

Treatment:

Other: Extended documentation

Other: Minimal documentation

EXT Data Set

Description:

Patients who received a targeted therapy based on NGS results (outside of a clinical trial)

Treatment:

Other: Extended documentation