The Added Value of Tissue or Liquid Biopsy NGS Profiling in Advanced Solid Tumor Treatment Decisions. (GeNeo2)

July 16, 2026 updated by: The Belgian Society of Medical Oncology

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).

> 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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

  1. To describe the number of patients receiving a treatment recommendation by the MTB.
  2. To describe the uptake of the MTB recommendations.
  3. To evaluate the treatment recommendations proposed by the MTB.
  4. To evaluate the reasons for discordance between the actual treatment and MTB recommendation.
  5. To evaluate the turnaround time of tumor CGP and ctDNA testing.
  6. To evaluate the technical success rate of tumor CGP and ctDNA testing.
  7. 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 Type

Observational

Enrollment (Estimated)

550

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 Backup

Study Locations

  • Belgium
      • Anderlecht, Belgium, 1070
        • Recruiting
        • Institute Jules Bordet
        • Contact:
        • Principal Investigator:
          • Philippe Aftimos, Oncologist
      • Antwerp, Belgium, 2030
        • Recruiting
        • ZAS
        • Contact:
        • Principal Investigator:
          • Kevin Punie, Oncologist
      • Bonheiden, Belgium, 2820
        • Recruiting
        • Imelda
        • Contact:
        • Principal Investigator:
          • Heidi Van den Bulck, Oncologist
      • Brasschaat, Belgium, 2930
        • Recruiting
        • AZ Klina
        • Contact:
        • Principal Investigator:
          • Wim Demey, Oncologist
      • Edegem, Belgium, 2650
        • Recruiting
        • Universitaire Ziekenhuis Antwerpen
        • Contact:
          • Greet De Craen, Study Coordinator
          • Phone Number: +32 3 821 41 21
          • Email: Onco.logi@uza.be
        • Principal Investigator:
          • Hans Prenen, Oncologist
      • Ghent, Belgium, 9000
        • Recruiting
        • UZ Gent
        • Contact:
        • Principal Investigator:
          • Eline Naert, Oncologist
      • Gilly, Belgium, 6060
        • Recruiting
        • GHDC
        • Contact:
        • Principal Investigator:
          • David Schröder, Oncologist
      • Hasselt, Belgium, 3500
      • Jette, Belgium, 1090
        • Recruiting
        • UZ Brussel
        • Contact:
        • Principal Investigator:
          • Sofie Joris, Oncologist
      • Leuven, Belgium, 3000
        • Recruiting
        • UZ Leuven
        • Contact:
        • Principal Investigator:
          • Sabine Tejpar, Oncologist
      • Liège, Belgium, 4000
        • Recruiting
        • CHU Liège Sart Tilman
        • Contact:
        • Principal Investigator:
          • Christine Gennigens, Oncologist
      • Namur, Belgium, 5000
        • Recruiting
        • CHU UCL Namur
        • Contact:
        • Principal Investigator:
          • Donatienne Taylor, Oncologist
      • Sint-Niklaas, Belgium, 9100
        • Recruiting
        • VITAZ
        • Contact:
        • Principal Investigator:
          • Willem Lybaert, Oncologist
      • Woluwe-Saint-Lambert, Belgium, 1200
        • Recruiting
        • Les Cliniques Universitaires St Luc
        • Contact:
        • Principal Investigator:
          • Cédric Van Marcke, Oncologist

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

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

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.

Description

Inclusion Criteria:

  1. Adult patient (minimum 18 years) able to provide written informed consent for GeNeo 2.0.
  2. ECOG Performance status ≤2
  3. 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.
  4. 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%

Exclusion Criteria:

  1. Life expectancy of ≤12 weeks according to the local investigator
  2. Clinically significant hematopoietic, renal and/or hepatic dysfunction, according to the local investigator, which would make them ineligible for MGTO therapy
  3. Patients unwilling to comply with GeNeo 2.0 protocol data collection, data sharing and other study procedures
  4. Patients unwilling to provide informed consent and comply with study procedures.

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Diagnostic test: Comprehensive NGS testing
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Through study completion, an average of 1 year.
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.
Through study completion, an average of 1 year.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of patients receiving a treatment recommendation
Time Frame: Through study completion, an average of 1 year.
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.
Through study completion, an average of 1 year.
% of uptake of the MTB recommendations
Time Frame: Through study completion, an average of 1 year.
The reported results will measure the % of patients, with at least 1 MTB recommendation, who initiated the recommended treatment.
Through study completion, an average of 1 year.
Treatment recommendations quality.
Time Frame: Through study completion, an average of 1 year.
The reported results will show a qualitative and quantitative descriptive analysis of treatment recommendations proposed by the MTB.
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.
The reported results will show a descriptive analysis of reasons for discordance between actual treatment and MTB recommendations.
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.
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).
Through study completion, an average of 1 year.

Collaborators and Investigators

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

Sponsor

The Belgian Society of Medical Oncology

Investigators

  • Study Chair: Philippe Aftimos, Oncologist, Jules Bordet Institute
  • Study Chair: Kevin Punie, Oncologist, ZAS
  • Study Chair: Jacques de Grève, Oncologist, Universitair Ziekenhuis Brussel

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)

October 22, 2025

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

April 1, 2029

Study Registration Dates

First Submitted

December 19, 2025

First Submitted That Met QC Criteria

July 16, 2026

First Posted (Actual)

July 20, 2026

Study Record Updates

Last Update Posted (Actual)

July 20, 2026

Last Update Submitted That Met QC Criteria

July 16, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • BSMO 2024-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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