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NCT Number: NCT05701150

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

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)

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Key information

Conditions

Advanced Solid Tumor

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Praxis für interdisziplinäre Onkologie & Hämatologie, Freiburg im Breisgau, Baden-Wurttemberg, Germany

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Minimal documentation

Other

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

Extended documentation

Other

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

Primary outcomes

  1. Molecular tumorboard utilization

    Time frame: 3 years

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

  2. Treatment reality after NGS analysis

    Time frame: 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

  3. NGS

    Time frame: 3 years

    Genomic alterations identified by multi-gene NGS panels

  4. Molecular tumorboard

    Time frame: 3 years

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

  5. Overall response rate

    Time frame: 3 years

    Overall response rate of targeted therapy based on NGS results

  6. Progression-free survival (PFS)

    Time frame: 3 years

    Progression-free survival from start of targeted therapy based on NGS results

  7. Overall survival

    Time frame: 3 years

    Overall survival from start of targeted therapy based on NGS results

  8. PFS ratio

    Time frame: 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)

Study contacts

Contact information is provided by the study sponsor or research team.

Marc Fischer

CONTACT

[email protected]

+49 30-8145344 ext. 44

Sponsors and collaborators

Lead sponsor

AIO-Studien-gGmbH

Other

Collaborators

  • Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company
  • Janssen-Cilag G.m.b.H
  • Merck Sharp & Dohme LLC

Registry information

Acronym: CONNECT

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Jan 27, 2023
Registry last updated
Feb 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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