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

Condition(s) studied

Investigational drug(s) / intervention(s)

Minimal documentation: Minimal data documentation only of patients without targeted therapy based on NGS results

Extended documentation: Extended data documentation of patients with targeted therapy based on NGS results

Study 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)

Eligibility

Primary outcome measure(s)

• Molecular tumorboard utilization — 3 years
  Proportion of patients who's case was discussed in a Molecular tumorboard
• Treatment reality after NGS analysis — 3 years
  Proportion of patients who received at least one targeted therapy based on NGS results, who exclusively received therapies other than targeted therapies based on NGS results or who did not receive any therapy
• NGS — 3 years
  Genomic alterations identified by multi-gene NGS panels
• Molecular tumorboard — 3 years
  Descriptive analysis of MTB-based therapy recommendations, their implementation rate and reasons for non-implementation
• Overall response rate — 3 years
  Overall response rate of targeted therapy based on NGS results
• Progression-free survival (PFS) — 3 years
  Progression-free survival from start of targeted therapy based on NGS results
• Overall survival — 3 years
  Overall survival from start of targeted therapy based on NGS results
• PFS ratio — 3 years
  PFS interval associated with targeted therapy(ies) administered after NGS analysis divided by the time to progression (TTP) interval associated with the last prior treatment(s)

Trial sites (3)

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