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

ConditionAdvanced Solid Tumor
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

This trial does not accept healthy volunteers

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 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)

Trial design

Design model

Cohort

Time perspective

Other

Treatments tested in this trial

  • Minimal documentation

    Other intervention

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

  • Extended documentation

    Other intervention

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

Treatment groups

3,000 Participants
are divided into 2 treatment groups
Group A: MIN Data Set2 interventions
Group B: EXT Data Set1 intervention

Trial outcomes

Primary outcomes

1

Molecular tumorboard utilization

Proportion of patients who's case was discussed in a Molecular tumorboard

Time frame
3 years
2

Treatment reality after NGS analysis

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

Time frame
3 years
3

NGS

Genomic alterations identified by multi-gene NGS panels

Time frame
3 years
4

Molecular tumorboard

Descriptive analysis of MTB-based therapy recommendations, their implementation rate and reasons for non-implementation

Time frame
3 years

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

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

Source ClinicalTrials.gov
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