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

February 13, 2025 updated by: AIO-Studien-gGmbH
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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
3000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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:
    • Bayern

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Other

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Molecular tumorboard utilization
Time Frame: 3 years
Proportion of patients who's case was discussed in a Molecular tumorboard
3 years
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 years
NGS
Time Frame: 3 years
Genomic alterations identified by multi-gene NGS panels
3 years
Molecular tumorboard
Time Frame: 3 years
Descriptive analysis of MTB-based therapy recommendations, their implementation rate and reasons for non-implementation
3 years
Overall response rate
Time Frame: 3 years
Overall response rate of targeted therapy based on NGS results
3 years
Progression-free survival (PFS)
Time Frame: 3 years
Progression-free survival from start of targeted therapy based on NGS results
3 years
Overall survival
Time Frame: 3 years
Overall survival from start of targeted therapy based on NGS results
3 years
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)
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
AIO-Studien-gGmbH

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Merck Sharp & Dohme LLC
Janssen-Cilag G.m.b.H
Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 8, 2022

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 18, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 18, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 27, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 13, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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