Advanced Solid Tumor CancerGeNeo2NCT07713550
The Added Value of Tissue or Liquid Biopsy NGS Profiling in Advanced Solid Tumor Treatment Decisions.
An observational study of Advanced Solid Tumor Cancer and Primary CNS Tumors, run by The Belgian Society of Medical Oncology at 14 sites in Belgium.
Trial summary
A total of 550 patients with metastatic solid tumors or primary CNS malignancy will be recruited on a first come first serve basis at one of the 14 participating centers : UZL, UZG, Imelda, ZAZ, AZ Klina, CHU Liège, GHdC, CHU UCL Namur, IJB, UZB, CUSL, UZA, VITAZ and Jessa Zh.. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumor Cancer, Primary CNS Tumors
- What is being tested?
- Comprehensive NGS testing
- How many people
- 550 participants
- Where
- 14 sitesBelgium
- Study dates
- 22 Oct 2025to Apr 2029
- 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: 550 consecutive patients with metastatic solid tumors that are eligible for a systemic therapy recruited on a first come first serve basis. 500 patients will be tested on a tissue biopsy and 50 patients will be tested on a liquid biopsy when tissue biopsy is not available or feasible for safety reason.
Who may be able to join
- Adult patient (minimum 18 years) able to provide written informed consent for GeNeo 2.0.
- ECOG Performance status ≤2
- Patients with advanced solid tumors or primary CNS tumors that are candidates for systemic anticancer therapy and open for enrollment in a potential downstream therapeutic trial. Enrollment in early treatment lines is strongly encouraged Tumor cohorts of breast cancer and lung cancer will be prioritized, with a minimum cap of 100 for each tumor type. Recruitment for all other tumor type cohorts will be capped at a maximum of 40 patients per tumor type. The MTB can decide on prematurely closing or extending tumor type cohorts based on treatment recommendations, clinical trial landscape or downstream treatment options. Enrollment of patients early in the advanced treatment setting will be strongly encouraged.
- Patients should have archived tissue available from a metastatic (preferred) or primary lesion biopsy for comprehensive profiling. The tissue should not be more than 2 years-old and fixed in 10% neutral buffered formalin. Tumor cell content should be >20%
Who cannot join
- Life expectancy of ≤12 weeks according to the local investigator
- Clinically significant hematopoietic, renal and/or hepatic dysfunction, according to the local investigator, which would make them ineligible for MGTO therapy
- Patients unwilling to comply with GeNeo 2.0 protocol data collection, data sharing and other study procedures
- Patients unwilling to provide informed consent and comply with study procedures.
Trial locations and contacts
14 sites in 1 country. Contact the study team or a site near you to ask about taking part.
14 sites in 1 country
Belgium14 sites, 14 recruiting
- Recruiting
Institute Jules Bordet
Anderlecht, 1070
Sophie Vankerckhove, Study Coordinator, +32 2 541 73 41, sophie.vankerckhove@hubruxelles.be
Philippe Aftimos, Oncologist
- Recruiting
ZAS
Antwerp, 2030
Abdelbari Baitar, Study Coordinator, +32 3 443 37 59, Abdelbari.Baitar@zas.be
Kevin Punie, Oncologist
- Recruiting
Imelda
Bonheiden, 2820
Ann Pauwels, Study Coordinator, +32 1 550 46 25, sec.oncologie@imelda.be
Heidi Van den Bulck, Oncologist
- Recruiting
AZ Klina
Brasschaat, 2930
Sofie Herman, Study Coordinator, +32 3 650 52 77, Sofie.Herman@klina.be
Wim Demey, Oncologist
- Recruiting
Universitaire Ziekenhuis Antwerpen
Edegem, 2650
Greet De Craen, Study Coordinator, +32 3 821 41 21, Onco.logi@uza.be
Hans Prenen, Oncologist
- Recruiting
UZ Gent
Ghent, 9000
Ellen De Bruycker, Study Coordinator, +32 9 332 15 92, Ellen.debruycker@uzgent.be
Eline Naert, Oncologist
- Recruiting
GHDC
Gilly, 6060
Matthias Papier, Study Coordinator, +32 6 011 06 09, matthias.papier@ghdc.be
David Schröder, Oncologist
- Recruiting
Jessa Ziekenhuis
Hasselt, 3500
Astrid Winnepenninckx, Study Coordinator, +32 11 33 79 92, astrid.winnepenninckx@jessazh.be
Hanne Oosterbos, Study Coordinator, Hanne.Oosterbos@jessazh.be
- Recruiting
UZ Brussel
Jette, 1090
Vanessa Fastenaekels, Study Coordinator, +32 2 474 9478, Vanessa.Fastenaekels@uzbrussel.be
Sofie Joris, Oncologist
- Recruiting
UZ Leuven
Leuven, 3000
Anne Baggerman, Study Coordinator, +32 16 34 66 78, Anne.Baggerman@uzleuven.be
Sabine Tejpar, Oncologist
- Recruiting
CHU Liège Sart Tilman
Liège, 4000
Hélène Schroeder, Study Coordinator, +32 4 323 40 74, hschroeder@chuliege.be
Christine Gennigens, Oncologist
- Recruiting
CHU UCL Namur
Namur, 5000
Sylvie Ledroit, Study Coordinator, +32 8 170 28 24, Sylvie.Ledroit@chuuclnamur.uclouvain.be
Donatienne Taylor, Oncologist
- Recruiting
VITAZ
Sint-Niklaas, 9100
Jenas Stevenheydens, Study Coordinator, +32 3 760 76 24, Jenas.Stevenheydens@vitaz.be
Willem Lybaert, Oncologist
- Recruiting
Les Cliniques Universitaires St Luc
Woluwe-Saint-Lambert, 1200
Anaïs Thomas, Study Coordinator, + 32 2 764 81 28, anais.thomas@saintluc.uclouvain.be
Cédric Van Marcke, Oncologist
About this study
Official title: The Added Value of Tissue or Liquid Biopsy NGS Profiling in Advanced Solid Tumor Treatment Decisions: The Belgian PRECISION Study of the BSMO in Collaboration With the Cancer Center of Sciensano.
A total of 550 patients with metastatic solid tumors or primary CNS malignancy will be recruited on a first come first serve basis at one of the 14 participating centers : UZL, UZG, Imelda, ZAZ, AZ Klina, CHU Liège, GHdC, CHU UCL Namur, IJB, UZB, CUSL, UZA, VITAZ and Jessa Zh..
> 500 patients with tissue available will undergo CGP centrally at UZ Leuven (Roche AVENIO Tumor Tissue CGP kits, Novaseq platform).
Read more
> 50 patients without tissue available will undergo liquid biopsy testing at Foundation Medicine (FoundationOne Liquid CDx).
The sequencing data generated by UZ Leuven laboratory will then be further analysed (secondary and tertiary analysis) by one of the eight laboratories participating in the study: UZL, UZG, IJB, CUSL, IPG, UZA, Jessa zh. and CHU Liège.
Read the detailed description
GeNeo 2.0 Study PRIMARY OBJECTIVE AND ENDPOINTS
To describe the genomic landscape of advanced solid tumors and primary CNS cancer as evaluated by CGP of tumor or ctDNA (for all included patients and tumor types separate). To do so, following calculations will be performed :
- Prevalence of ESCAT level 1, 2, 3 or 4 alterations based on MTB discussion of Roche AVENIO Tumor Tissue CGP kit results.
- Prevalence of ESCAT level 1, 2, 3 or 4 alterations based on MTB discussion of Foundation One Liquid CDx results.
- Prevalence of genomic alterations according to altered gene, type of variant of tumor type.
GeNeo 2.0 Study SECONDARY OBJECTIVES AND ENDPOINTS
- To describe the number of patients receiving a treatment recommendation by the MTB.
- To describe the uptake of the MTB recommendations.
- To evaluate the treatment recommendations proposed by the MTB.
- To evaluate the reasons for discordance between the actual treatment and MTB recommendation.
- To evaluate the turnaround time of tumor CGP and ctDNA testing.
- To evaluate the technical success rate of tumor CGP and ctDNA testing.
- To evaluate the impact of CGP on patient referral and trial inclusion.
All secondary analyses will be performed for all included patients, for tumor/ctDNA CGP testing and for tumor types separate. To do so, following calculations will be performed :
- Proportion of patients receiving at least 1 MTB recommendation
- Proportion of patients with at least 1 MTB recommendation that initiated the recommended treatment.
- Qualitative and quantitative descriptive analysis of treatment recommendations proposed by the MTB.
- Descriptive analysis of reasons for discordance between actual treatment and MTB recommendations.
- Proportion of patients with a time between sample pick-up and MTB report ≤28 days.
- Proportion of patients in which tumor CGP and ctDNA testing failed for technical reasons + descriptive analysis of potential reasons.
- Descriptive analysis of patient referrals between centers for participation in genotype-driven clinical trials.
- Conditions
- Advanced Solid Tumor Cancer, Primary CNS Tumors
- Being tested
- Comprehensive NGS testing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comprehensive NGS testingDiagnostic test
To determine the Added Value of Tissue and Liquid Biopsy NGS profiling in Advanced Solid Tumor Treatment Decisions: The Belgian PRECISION study of the BSMO in collaboration with the Cancer Center of Sciensano (GeNeo 2.0)
| Study group | Role | What they receive |
|---|---|---|
| Agnostic cohort | Tumor cohorts of breast cancer and lung cancer will be prioritized, with a minimum cap of 100 for each tumor type. Recruitment for all other tumor type cohorts will be capped at a maximum of 40 patients per tumor type. The MTB can decide on prematurely closing or extending tumor type cohorts based on treatment recommendations, clinical trial landscape or downstream treatment options. Enrollment of patients early in the advanced treatment setting will be strongly encouraged. Receives: Diagnostic Test: Comprehensive NGS testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Distribution of ESCAT Actionability Levels Identified by Comprehensive Genomic Profiling
Participants with at least one molecular tumor board recommendation were classified according to the highest ESCAT level identified following comprehensive genomic profiling. ESCAT Level I represents alterations with established clinical utility whereas Levels II-IV represent progressively lower levels of clinical evidence. The reported results will count the number of participants for each ESCAT level group.
Measured: Through study completion, an average of 1 year.
Distribution of Genomic Alteration Types Identified by Comprehensive Genomic Profiling
The reported values represent the prevalence of genomic alterations according to altered gene, type of variant of tumor type.
Measured: Through study completion, an average of 1 year.
Secondary outcomes (5)
Number of patients receiving a treatment recommendation
The reported results will count the number and percentage of participants for whom at least one treatment recommendation was issued by the Molecular Tumor Board following comprehensive genomic profiling.
Measured: Through study completion, an average of 1 year.
% of uptake of the MTB recommendations
The reported results will measure the % of patients, with at least 1 MTB recommendation, who initiated the recommended treatment.
Measured: Through study completion, an average of 1 year.
Treatment recommendations quality.
The reported results will show a qualitative and quantitative descriptive analysis of treatment recommendations proposed by the MTB.
Measured: Through study completion, an average of 1 year.
Participants whose treatment differed from the Molecular Tumor Board recommendation
The reported results will show a descriptive analysis of reasons for discordance between actual treatment and MTB recommendations.
Measured: Through study completion, an average of 1 year.
Participants with turnaround time within 28 days
The reported results will count the number and percentage of participants for whom the interval between sample receipt and Molecular Tumor Board recommendation did not exceed 28 days (14 days for testing and 14 days for MTB review).
Measured: Through study completion, an average of 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2026
- Study start22 Oct 2025
- Primary completionMay 2027 (estimated)
- Study completionApr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid Tumor CancerStudies 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
- Prospective
- Enrolment
- 550 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Belgian Society of Medical Oncology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Philippe Aftimos, Oncologist, Study chair, Jules Bordet InstituteKevin Punie, Oncologist, Study chair, ZASJacques de Grève, Oncologist, Study chair, Universitair Ziekenhuis Brussel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07713550
- Sponsor's protocol ID
- BSMO 2024-1
- Acronym
- GeNeo2
- Status last verified
- Jan 2026
- First submitted
- 19 Dec 2025
- Last updated
- 20 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Added Value of Tissue or Liquid Biopsy NGS Profiling in Advanced Solid Tumor Treatment Decisions: The Belgian PRECISION Study of the BSMO in Collaboration With the Cancer Center of Sciensano.
- ClinicalTrials.gov ID
- NCT07713550
- Acronym / sponsor ID
- GeNeo2 / BSMO 2024-1
- Conditions
- Advanced Solid Tumor Cancer, Primary CNS Tumors
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 550 participants (estimated)
- Lead sponsor
- The Belgian Society of Medical OncologyUniversity, hospital or other
- Study start
- 22 Oct 2025 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- Apr 2029 (estimated)
- First posted
- 20 Jul 2026 (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.
A total of 550 patients with metastatic solid tumors or primary CNS malignancy will be recruited on a first come first serve basis at one of the 14 participating centers : UZL, UZG, Imelda, ZAZ, AZ Klina, CHU Liège, GHdC, CHU UCL Namur, IJB, UZB, CUSL, UZA, VITAZ and Jessa Zh..
> 500 patients with tissue available will undergo CGP centrally at UZ Leuven (Roche AVENIO Tumor Tissue CGP kits, Novaseq platform).
> 50 patients without tissue available will undergo liquid biopsy testing at Foundation Medicine (FoundationOne Liquid CDx).
The sequencing data generated by UZ Leuven laboratory will then be further analysed (secondary and tertiary analysis) by one of the eight laboratories participating in the study: UZL, UZG, IJB, CUSL, IPG, UZA, Jessa zh. and CHU Liège.
Detailed description
GeNeo 2.0 Study PRIMARY OBJECTIVE AND ENDPOINTS
To describe the genomic landscape of advanced solid tumors and primary CNS cancer as evaluated by CGP of tumor or ctDNA (for all included patients and tumor types separate). To do so, following calculations will be performed :
- Prevalence of ESCAT level 1, 2, 3 or 4 alterations based on MTB discussion of Roche AVENIO Tumor Tissue CGP kit results.
- Prevalence of ESCAT level 1, 2, 3 or 4 alterations based on MTB discussion of Foundation One Liquid CDx results.
- Prevalence of genomic alterations according to altered gene, type of variant of tumor type.
GeNeo 2.0 Study SECONDARY OBJECTIVES AND ENDPOINTS
- To describe the number of patients receiving a treatment recommendation by the MTB.
- To describe the uptake of the MTB recommendations.
- To evaluate the treatment recommendations proposed by the MTB.
- To evaluate the reasons for discordance between the actual treatment and MTB recommendation.
- To evaluate the turnaround time of tumor CGP and ctDNA testing.
- To evaluate the technical success rate of tumor CGP and ctDNA testing.
- To evaluate the impact of CGP on patient referral and trial inclusion.
All secondary analyses will be performed for all included patients, for tumor/ctDNA CGP testing and for tumor types separate. To do so, following calculations will be performed :
- Proportion of patients receiving at least 1 MTB recommendation
- Proportion of patients with at least 1 MTB recommendation that initiated the recommended treatment.
- Qualitative and quantitative descriptive analysis of treatment recommendations proposed by the MTB.
- Descriptive analysis of reasons for discordance between actual treatment and MTB recommendations.
- Proportion of patients with a time between sample pick-up and MTB report ≤28 days.
- Proportion of patients in which tumor CGP and ctDNA testing failed for technical reasons + descriptive analysis of potential reasons.
- Descriptive analysis of patient referrals between centers for participation in genotype-driven clinical trials.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Agnostic cohort | – | Diagnostic Test: Comprehensive NGS testingTumor cohorts of breast cancer and lung cancer will be prioritized, with a minimum cap of 100 for each tumor type. Recruitment for all other tumor type cohorts will be capped at a maximum of 40 patients per tumor type. The MTB can decide on prematurely closing or extending tumor type cohorts based on treatment recommendations, clinical trial landscape or downstream treatment options. Enrollment of patients early in the advanced treatment setting will be strongly encouraged. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 550 consecutive patients with metastatic solid tumors that are eligible for a systemic therapy recruited on a first come first serve basis. 500 patients will be tested on a tissue biopsy and 50 patients will be tested on a liquid biopsy when tissue biopsy is not available or feasible for safety reason.
Key inclusion criteria (4 listed)
- Adult patient (minimum 18 years) able to provide written informed consent for GeNeo 2.0.
- ECOG Performance status ≤2
- Patients with advanced solid tumors or primary CNS tumors that are candidates for systemic anticancer therapy and open for enrollment in a potential downstream therapeutic trial. Enrollment in early treatment lines is strongly encouraged Tumor cohorts of breast cancer and lung cancer will be prioritized, with a minimum cap of 100 for each tumor type. Recruitment for all other tumor type cohorts will be capped at a maximum of 40 patients per tumor type. The MTB can decide on prematurely closing or extending tumor type cohorts based on treatment recommendations, clinical trial landscape or downstream treatment options. Enrollment of patients early in the advanced treatment setting will be strongly encouraged.
- Patients should have archived tissue available from a metastatic (preferred) or primary lesion biopsy for comprehensive profiling. The tissue should not be more than 2 years-old and fixed in 10% neutral buffered formalin. Tumor cell content should be >20%
Key exclusion criteria (4 listed)
- Life expectancy of ≤12 weeks according to the local investigator
- Clinically significant hematopoietic, renal and/or hepatic dysfunction, according to the local investigator, which would make them ineligible for MGTO therapy
- Patients unwilling to comply with GeNeo 2.0 protocol data collection, data sharing and other study procedures
- Patients unwilling to provide informed consent and comply with study procedures.
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 |
|---|---|---|
| Comprehensive NGS testingTo determine the Added Value of Tissue and Liquid Biopsy NGS profiling in Advanced Solid Tumor Treatment Decisions: The Belgian PRECISION study of the BSMO in collaboration with the Cancer Center of Sciensano (GeNeo 2.0) | Diagnostic test | Agnostic cohort |
Primary outcome
Distribution of ESCAT Actionability Levels Identified by Comprehensive Genomic Profiling
Time frame: Through study completion, an average of 1 year.
Participants with at least one molecular tumor board recommendation were classified according to the highest ESCAT level identified following comprehensive genomic profiling. ESCAT Level I represents alterations with established clinical utility whereas Levels II-IV represent progressively lower levels of clinical evidence. The reported results will count the number of participants for each ESCAT level group.
Distribution of Genomic Alteration Types Identified by Comprehensive Genomic Profiling
Time frame: Through study completion, an average of 1 year.
The reported values represent the prevalence of genomic alterations according to altered gene, type of variant of tumor type.
5 secondary outcomes
Number of patients receiving a treatment recommendation
Time frame: Through study completion, an average of 1 year.
% of uptake of the MTB recommendations
Time frame: Through study completion, an average of 1 year.
Treatment recommendations quality.
Time frame: Through study completion, an average of 1 year.
Participants whose treatment differed from the Molecular Tumor Board recommendation
Time frame: Through study completion, an average of 1 year.
Participants with turnaround time within 28 days
Time frame: Through study completion, an average of 1 year.
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 20 Jul 2026.
- Individual participant dataSharing planned: No
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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.
Philippe Aftimos, Oncologist study chair
Jules Bordet Institute
Kevin Punie, Oncologist study chair
ZAS
Jacques de Grève, Oncologist study chair
Universitair Ziekenhuis Brussel
14 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 Cancer and Primary CNS Tumors, run by The Belgian Society of Medical Oncology at 14 sites in Belgium.
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 4 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 20 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in Belgium. 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 Julie Maetens (+32 2 642 54 90, Julie.Maetens@sciensano.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Distribution of ESCAT Actionability Levels Identified by Comprehensive Genomic Profiling (time frame: Through study completion, an average of 1 year.). The study lists 2 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 20 Jul 2026.