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

Study Overview

• Status: Recruiting
• Conditions: Advanced Solid Tumor
• Intervention / Treatment: Other: Minimal documentation; Other: Extended documentation

Detailed 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.

• Study Type: Observational
• Enrollment (Estimated): 3000

Contacts and Locations

• Study Contact: Name: Marc Fischer; Phone Number: 44 +49 30-8145344; Email: marc.fischer@aio-studien-ggmbh.de

Study Locations

• Germany
  • Baden-Württemberg
    • Freiburg, Baden-Württemberg, Germany, 79110
      • Recruiting
      • Praxis für interdisziplinäre Onkologie & Hämatologie
      • Contact: Matthias Zaiss, Dr. med.
    • Mannheim, Baden-Württemberg, Germany, 68167
      • Not yet recruiting
      • Medizinische Fakultät Mannheim der Universität Heidelberg
      • Contact: Sonja Loges, Prof. Dr. Dr. med.; Phone Number: 1757 +49 621 383; Email: Sonja.Loges@medma.uni-heidelberg.de
  • Bayern
    • München, Bayern, Germany, 81377
      • Not yet recruiting
      • Klinikum der Universität München
      • Contact: Benedikt Westphalen, Dr. med.; Phone Number: 75250 +49 89 4400; Email: christoph_benedikt.westphalen@med.uni-muenchen.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study 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)

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Other

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
MIN Data Set; Patients who did not receive a targeted therapy based on NGS results (outside of a clinical trial)	Other: Minimal documentation; Minimal data documentation only of patients without targeted therapy based on NGS results; Other: Extended documentation; Extended data documentation of patients with targeted therapy based on NGS results
EXT Data Set; Patients who received a targeted therapy based on NGS results (outside of a clinical trial)	Other: Extended documentation; Extended data documentation of patients with targeted therapy based on NGS results

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Molecular tumorboard utilization	Proportion of patients who's case was discussed in a Molecular tumorboard	3 years
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	3 years
NGS	Genomic alterations identified by multi-gene NGS panels	3 years
Molecular tumorboard	Descriptive analysis of MTB-based therapy recommendations, their implementation rate and reasons for non-implementation	3 years
Overall response rate	Overall response rate of targeted therapy based on NGS results	3 years
Progression-free survival (PFS)	Progression-free survival from start of targeted therapy based on NGS results	3 years
Overall survival	Overall survival from start of targeted therapy based on NGS results	3 years
PFS ratio	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)	3 years

Collaborators and Investigators

• Sponsor: AIO-Studien-gGmbH
• Collaborators: Merck Sharp & Dohme LLC; Janssen-Cilag G.m.b.H; Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company

Study record dates

Study Major Dates

• Study Start (Actual): December 8, 2022
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: January 18, 2023
• First Submitted That Met QC Criteria: January 18, 2023
• First Posted (Actual): January 27, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 13, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Adenoma; Neoplasms, Mesothelial; Mesothelioma
• Other Study ID Numbers: AIO-TF-0122

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No