Advanced Solid TumorCONNECTNCT05701150
AIO-BNHO Comprehensive Clinico-genomics Database Network - AIO-BNHO CONNECT
An observational study of Advanced Solid Tumor, run by AIO-Studien-gGmbH at 3 sites in Germany.
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)… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumor
- What is being tested?
- Minimal documentation and Extended documentation
- How many people
- 3,000 participants
- Where
- 3 sitesGermany
- Study dates
- 8 Dec 2022to Dec 2025
- How long will I take part?
- 36 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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)
Who may be able to join
- 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)
Who cannot join
- Diagnosis of NSCLC/SCLC (C34) or mesothelioma (C45)
- NGS results older than two years at the date of patient inclusion
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Germany3 sites, 3 recruiting
- Recruiting
Praxis für interdisziplinäre Onkologie & Hämatologie
Freiburg im Breisgau, Baden-Wurttemberg, 79110
Matthias Zaiss, Dr. med.
- Not yet recruiting
Medizinische Fakultät Mannheim der Universität Heidelberg
Mannheim, Baden-Wurttemberg, 68167
Sonja Loges, Prof. Dr. Dr. med., +49 621 383 ext. 1757, Sonja.Loges@medma.uni-heidelberg.de
- Not yet recruiting
Klinikum der Universität München
München, Bavaria, 81377
Benedikt Westphalen, Dr. med., +49 89 4400 ext. 75250, christoph_benedikt.westphalen@med.uni-muenchen.de
About this study
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)
Read the 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.
- Conditions
- Advanced Solid Tumor
- Being tested
- Minimal documentation, Extended documentation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Minimal documentationOther
Minimal data documentation only of patients without targeted therapy based on NGS results
Extended documentationOther
Extended data documentation of patients with targeted therapy based on NGS results
| Study group | Role | What they receive |
|---|---|---|
| MIN Data Set | Patients who did not receive a targeted therapy based on NGS results (outside of a clinical trial) Receives: Other: Minimal documentation; Other: Extended documentation | |
| EXT Data Set | Patients who received a targeted therapy based on NGS results (outside of a clinical trial) Receives: Other: Extended documentation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Molecular tumorboard utilization
Proportion of patients who's case was discussed in a Molecular tumorboard
Measured: 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
Measured: 3 years
NGS
Genomic alterations identified by multi-gene NGS panels
Measured: 3 years
Molecular tumorboard
Descriptive analysis of MTB-based therapy recommendations, their implementation rate and reasons for non-implementation
Measured: 3 years
Overall response rate
Overall response rate of targeted therapy based on NGS results
Measured: 3 years
Progression-free survival (PFS)
Progression-free survival from start of targeted therapy based on NGS results
Measured: 3 years
Overall survival
Overall survival from start of targeted therapy based on NGS results
Measured: 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)
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2023
- Study start8 Dec 2022
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 3,000 participants (estimated)
- Target duration
- 36 Months
Sponsor and investigators
- Lead sponsor
- AIO-Studien-gGmbH
- Sponsor type
- University, hospital or other
- Collaborators
- Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company, Merck Sharp & Dohme LLC, Janssen-Cilag G.m.b.H
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05701150
- Sponsor's protocol ID
- AIO-TF-0122
- Acronym
- CONNECT
- Status last verified
- Feb 2025
- First submitted
- 18 Jan 2023
- Last updated
- 17 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AIO-BNHO Comprehensive Clinico-genomics Database Network - AIO-BNHO CONNECT
- ClinicalTrials.gov ID
- NCT05701150
- Acronym / sponsor ID
- CONNECT / AIO-TF-0122
- Conditions
- Advanced Solid Tumor
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- AIO-Studien-gGmbHUniversity, hospital or other
- Collaborators
- Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company, Merck Sharp & Dohme LLC, Janssen-Cilag G.m.b.H
- Study start
- 8 Dec 2022 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 27 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
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 design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 36 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MIN Data Set | – | Other: Minimal documentation, Other: Extended documentationPatients who did not receive a targeted therapy based on NGS results (outside of a clinical trial) |
| EXT Data Set | – | Other: Extended documentationPatients who received a targeted therapy based on NGS results (outside of a clinical trial) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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)
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (2 listed)
- Diagnosis of NSCLC/SCLC (C34) or mesothelioma (C45)
- NGS results older than two years at the date of patient inclusion
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Minimal documentationMinimal data documentation only of patients without targeted therapy based on NGS results | Other | MIN Data Set |
| Extended documentationExtended data documentation of patients with targeted therapy based on NGS results | Other | EXT Data Set, MIN Data Set |
Primary outcome
Molecular tumorboard utilization
Time frame: 3 years
Proportion of patients who's case was discussed in a Molecular tumorboard
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
NGS
Time frame: 3 years
Genomic alterations identified by multi-gene NGS panels
Molecular tumorboard
Time frame: 3 years
Descriptive analysis of MTB-based therapy recommendations, their implementation rate and reasons for non-implementation
Overall response rate
Time frame: 3 years
Overall response rate of targeted therapy based on NGS results
Progression-free survival (PFS)
Time frame: 3 years
Progression-free survival from start of targeted therapy based on NGS results
Overall survival
Time frame: 3 years
Overall survival from start of targeted therapy based on NGS results
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Advanced Solid Tumor, run by AIO-Studien-gGmbH at 3 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marc Fischer (+49 30-8145344 ext. 44, marc.fischer@aio-studien-ggmbh.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Molecular tumorboard utilization (time frame: 3 years). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2025.