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

Advanced Solid Tumor Clinical Trial

— CONNECT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05701150
• Other study ID #: AIO-TF-0122
• Status: Recruiting
• Start date: December 8, 2022
• Est. completion date: December 2025

Study information

• Verified date: November 2023
• Source: AIO-Studien-gGmbH
• Contact: Marc Fischer
• Phone: +49 30-8145344
• Email: marc.fischer[@]aio-studien-ggmbh.de
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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)

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3000
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Advanced Solid Tumor

Intervention

Other:
• 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

Locations

Country	Name	City	State
Germany	Praxis für interdisziplinäre Onkologie & Hämatologie	Freiburg	Baden-Württemberg
Germany	Medizinische Fakultät Mannheim der Universität Heidelberg	Mannheim	Baden-Württemberg
Germany	Klinikum der Universität München	München	Bayern

Sponsors (4)

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

Country where clinical trial is conducted

Germany, 

Outcome

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