Esta página foi traduzida automaticamente e a precisão da tradução não é garantida. Por favor, consulte o versão em inglês para um texto fonte.

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

16 de julho de 2026 atualizado 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.

Visão geral do estudo

Status

Recrutamento

Condições

Intervenção / Tratamento

Descrição detalhada

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 estudo

Observacional

Inscrição (Estimado)

550

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Estude backup de contato

Locais de estudo

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

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

Não

Método de amostragem

Amostra de Probabilidade

População do estudo

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.

Descrição

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.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

Coortes e Intervenções

Grupo / Coorte
Intervenção / Tratamento
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.
Teste de diagnostico: 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)

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Distribution of ESCAT Actionability Levels Identified by Comprehensive Genomic Profiling
Prazo: 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
Prazo: 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 resultados secundários

Medida de resultado
Descrição da medida
Prazo
Number of patients receiving a treatment recommendation
Prazo: 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
Prazo: 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.
Prazo: 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
Prazo: 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
Prazo: 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

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

The Belgian Society of Medical Oncology

Investigadores

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

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

22 de outubro de 2025

Conclusão Primária (Estimado)

1 de maio de 2027

Conclusão do estudo (Estimado)

1 de abril de 2029

Datas de inscrição no estudo

Enviado pela primeira vez

19 de dezembro de 2025

Enviado pela primeira vez que atendeu aos critérios de CQ

16 de julho de 2026

Primeira postagem (Real)

20 de julho de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

20 de julho de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

16 de julho de 2026

Última verificação

1 de janeiro de 2026

Mais Informações

Termos relacionados a este estudo

Outros números de identificação do estudo

  • BSMO 2024-1

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

Se inscrever