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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAIO-Studien-gGmbH

About this trial

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)

Eligibility criteria

Qualifiers

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)

Disqualifiers

Diagnosis of NSCLC/SCLC (C34) or mesothelioma (C45)

NGS results older than two years at the date of patient inclusion

Trial design

Treatments tested in this trial

  • Minimal documentation
  • Extended documentation

Treatment groups

3,000 Participants
are divided into 2 treatment groups

Sponsors and collaborators

AIO-Studien-gGmbH

Lead sponsor

Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company

Collaborator

Merck Sharp & Dohme LLC

Collaborator

Janssen-Cilag G.m.b.H

Collaborator