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

16 de julio de 2026 actualizado por: 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.

Descripción general del estudio

Estado

Reclutamiento

Condiciones

Intervención / Tratamiento

Descripción detallada

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.

Tipo de estudio

De observación

Inscripción (Estimado)

550

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

Copia de seguridad de contactos de estudio

Ubicaciones de estudio

  • Bélgica
      • Anderlecht, Bélgica, 1070
        • Reclutamiento
        • Institute Jules Bordet
        • Contacto:
        • Investigador principal:
          • Philippe Aftimos, Oncologist
      • Antwerp, Bélgica, 2030
        • Reclutamiento
        • ZAS
        • Contacto:
          • Abdelbari Baitar, Study Coordinator
          • Número de teléfono: +32 3 443 37 59
          • Correo electrónico: Abdelbari.Baitar@zas.be
        • Investigador principal:
          • Kevin Punie, Oncologist
      • Bonheiden, Bélgica, 2820
        • Reclutamiento
        • Imelda
        • Contacto:
          • Ann Pauwels, Study Coordinator
          • Número de teléfono: +32 1 550 46 25
          • Correo electrónico: sec.oncologie@imelda.be
        • Investigador principal:
          • Heidi Van den Bulck, Oncologist
      • Brasschaat, Bélgica, 2930
        • Reclutamiento
        • AZ Klina
        • Contacto:
          • Sofie Herman, Study Coordinator
          • Número de teléfono: +32 3 650 52 77
          • Correo electrónico: Sofie.Herman@klina.be
        • Investigador principal:
          • Wim Demey, Oncologist
      • Edegem, Bélgica, 2650
        • Reclutamiento
        • Universitaire Ziekenhuis Antwerpen
        • Contacto:
          • Greet De Craen, Study Coordinator
          • Número de teléfono: +32 3 821 41 21
          • Correo electrónico: Onco.logi@uza.be
        • Investigador principal:
          • Hans Prenen, Oncologist
      • Ghent, Bélgica, 9000
        • Reclutamiento
        • UZ Gent
        • Contacto:
        • Investigador principal:
          • Eline Naert, Oncologist
      • Gilly, Bélgica, 6060
        • Reclutamiento
        • GHdC
        • Contacto:
          • Matthias Papier, Study Coordinator
          • Número de teléfono: +32 6 011 06 09
          • Correo electrónico: matthias.papier@ghdc.be
        • Investigador principal:
          • David Schröder, Oncologist
      • Hasselt, Bélgica, 3500
        • Reclutamiento
        • Jessa Ziekenhuis
        • Contacto:
        • Contacto:
        • Investigador principal:
          • Jeroen Mebis, Oncologist
      • Jette, Bélgica, 1090
        • Reclutamiento
        • UZ Brussel
        • Contacto:
        • Investigador principal:
          • Sofie Joris, Oncologist
      • Leuven, Bélgica, 3000
        • Reclutamiento
        • UZ Leuven
        • Contacto:
        • Investigador principal:
          • Sabine Tejpar, Oncologist
      • Liège, Bélgica, 4000
        • Reclutamiento
        • CHU Liège Sart Tilman
        • Contacto:
          • Hélène Schroeder, Study Coordinator
          • Número de teléfono: +32 4 323 40 74
          • Correo electrónico: hschroeder@chuliege.be
        • Investigador principal:
          • Christine Gennigens, Oncologist
      • Namur, Bélgica, 5000
        • Reclutamiento
        • CHU UCL Namur
        • Contacto:
        • Investigador principal:
          • Donatienne Taylor, Oncologist
      • Sint-Niklaas, Bélgica, 9100
        • Reclutamiento
        • Vitaz
        • Contacto:
        • Investigador principal:
          • Willem Lybaert, Oncologist
      • Woluwe-Saint-Lambert, Bélgica, 1200
        • Reclutamiento
        • Les Cliniques Universitaires St Luc
        • Contacto:
        • Investigador principal:
          • Cédric Van Marcke, Oncologist

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Método de muestreo

Muestra de probabilidad

Población de estudio

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.

Descripción

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 de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

Cohortes e Intervenciones

Grupo / Cohorte
Intervención / Tratamiento
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.
Prueba de diagnóstico: 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)

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Distribution of ESCAT Actionability Levels Identified by Comprehensive Genomic Profiling
Periodo de tiempo: 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
Periodo de tiempo: 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.

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Number of patients receiving a treatment recommendation
Periodo de tiempo: 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
Periodo de tiempo: 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.
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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.

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

The Belgian Society of Medical Oncology

Investigadores

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

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

22 de octubre de 2025

Finalización primaria (Estimado)

1 de mayo de 2027

Finalización del estudio (Estimado)

1 de abril de 2029

Fechas de registro del estudio

Enviado por primera vez

19 de diciembre de 2025

Primero enviado que cumplió con los criterios de control de calidad

16 de julio de 2026

Publicado por primera vez (Actual)

20 de julio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

20 de julio de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

16 de julio de 2026

Última verificación

1 de enero de 2026

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • BSMO 2024-1

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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