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

Studien-Informationen Einschlusskriterien Studien-Rationale Studien-Arme Geprüfte Regime

Rekrutierend

NCT-Nummer:
NCT05701150

Studienbeginn:
Dezember 2022

Letztes Update:
09.11.2023

Wirkstoff:
-

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
AIO-Studien-gGmbH

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

Kontakt

Marc Fischer
Kontakt:
Phone: +49 30-8145344
Phone (ext.): 44
E-Mail: marc.fischer@aio-studien-ggmbh.de» Kontaktdaten anzeigen

Studienlocations
(3 von 3)

Praxis für interdisziplinäre Onkologie & Hämatologie
79110 Freiburg
(Baden-Württemberg)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Matthias Zaiss, Dr. med.» Ansprechpartner anzeigen

Medizinische Fakultät Mannheim der Universität Heidelberg
68167 Mannheim
(Baden-Württemberg)
GermanyNoch nicht rekrutierend» Google-Maps
Ansprechpartner:
Sonja Loges, Prof. Dr. Dr. med.
Phone: +49 621 383
Phone (ext.): 1757
E-Mail: Sonja.Loges@medma.uni-heidelberg.de» Ansprechpartner anzeigen

Brustzentrum am Klinikum der Universität München
Marchioninistraße 15
80337 München
DeutschlandNoch nicht rekrutierend» Google-Maps
Ansprechpartner:
Benedikt Westphalen, Dr. med.
Phone: +49 89 4400
Phone (ext.): 75250
E-Mail: christoph_benedikt.westphalen@med.uni-muenchen.de» Ansprechpartner anzeigen

Studien-Informationen

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.

Ein-/Ausschlusskriterien

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

Studien-Rationale

Primary outcome:

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)

Studien-Arme

MIN Data Set
Patients who did not receive a targeted therapy based on NGS results (outside of a clinical trial)
EXT Data Set
Patients who received a targeted therapy based on NGS results (outside of a clinical trial)

Geprüfte Regime

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

Quelle: ClinicalTrials.gov

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