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

16 juillet 2026 mis à jour par: 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.

Aperçu de l'étude

Statut

Recrutement

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Observationnel

Inscription (Estimé)

550

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Sauvegarde des contacts de l'étude

Lieux d'étude

  • Belgique
      • Anderlecht, Belgique, 1070
        • Recrutement
        • Institute Jules Bordet
        • Contact:
        • Chercheur principal:
          • Philippe Aftimos, Oncologist
      • Antwerp, Belgique, 2030
        • Recrutement
        • ZAS
        • Contact:
        • Chercheur principal:
          • Kevin Punie, Oncologist
      • Bonheiden, Belgique, 2820
        • Recrutement
        • Imelda
        • Contact:
        • Chercheur principal:
          • Heidi Van den Bulck, Oncologist
      • Brasschaat, Belgique, 2930
        • Recrutement
        • AZ Klina
        • Contact:
        • Chercheur principal:
          • Wim Demey, Oncologist
      • Edegem, Belgique, 2650
        • Recrutement
        • Universitaire Ziekenhuis Antwerpen
        • Contact:
          • Greet De Craen, Study Coordinator
          • Numéro de téléphone: +32 3 821 41 21
          • E-mail: Onco.logi@uza.be
        • Chercheur principal:
          • Hans Prenen, Oncologist
      • Ghent, Belgique, 9000
        • Recrutement
        • UZ Gent
        • Contact:
        • Chercheur principal:
          • Eline Naert, Oncologist
      • Gilly, Belgique, 6060
        • Recrutement
        • GHdC
        • Contact:
        • Chercheur principal:
          • David Schröder, Oncologist
      • Hasselt, Belgique, 3500
      • Jette, Belgique, 1090
        • Recrutement
        • UZ Brussel
        • Contact:
        • Chercheur principal:
          • Sofie Joris, Oncologist
      • Leuven, Belgique, 3000
        • Recrutement
        • UZ Leuven
        • Contact:
        • Chercheur principal:
          • Sabine Tejpar, Oncologist
      • Liège, Belgique, 4000
        • Recrutement
        • CHU Liège Sart Tilman
        • Contact:
          • Hélène Schroeder, Study Coordinator
          • Numéro de téléphone: +32 4 323 40 74
          • E-mail: hschroeder@chuliege.be
        • Chercheur principal:
          • Christine Gennigens, Oncologist
      • Namur, Belgique, 5000
        • Recrutement
        • CHU UCL Namur
        • Contact:
        • Chercheur principal:
          • Donatienne Taylor, Oncologist
      • Sint-Niklaas, Belgique, 9100
        • Recrutement
        • Vitaz
        • Contact:
        • Chercheur principal:
          • Willem Lybaert, Oncologist
      • Woluwe-Saint-Lambert, Belgique, 1200
        • Recrutement
        • Les Cliniques Universitaires St Luc
        • Contact:
        • Chercheur principal:
          • Cédric Van Marcke, Oncologist

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

Méthode d'échantillonnage

Échantillon de probabilité

Population étudiée

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.

La 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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

Cohortes et interventions

Groupe / Cohorte
Intervention / Traitement
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.
Test diagnostique: 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)

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Distribution of ESCAT Actionability Levels Identified by Comprehensive Genomic Profiling
Délai: 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
Délai: 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.

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Number of patients receiving a treatment recommendation
Délai: 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
Délai: 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.
Délai: 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
Délai: 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
Délai: 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.

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

The Belgian Society of Medical Oncology

Les enquêteurs

  • Chaise d'étude: Philippe Aftimos, Oncologist, Jules Bordet Institute
  • Chaise d'étude: Kevin Punie, Oncologist, ZAS
  • Chaise d'étude: Jacques de Grève, Oncologist, Universitair Ziekenhuis Brussel

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

22 octobre 2025

Achèvement primaire (Estimé)

1 mai 2027

Achèvement de l'étude (Estimé)

1 avril 2029

Dates d'inscription aux études

Première soumission

19 décembre 2025

Première soumission répondant aux critères de contrôle qualité

16 juillet 2026

Première publication (Réel)

20 juillet 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

20 juillet 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

16 juillet 2026

Dernière vérification

1 janvier 2026

Plus d'information

Termes liés à cette étude

Autres numéros d'identification d'étude

  • BSMO 2024-1

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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