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

16. juli 2026 oppdatert av: 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.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Observasjonsmessig

Registrering (Antatt)

550

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studer Kontakt Backup

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Prøvetakingsmetode

Sannsynlighetsprøve

Studiepopulasjon

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.

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Kohorter og intervensjoner

Gruppe / Kohort
Intervensjon / Behandling
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.
Diagnostisk 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)

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Distribution of ESCAT Actionability Levels Identified by Comprehensive Genomic Profiling
Tidsramme: 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
Tidsramme: 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.

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Number of patients receiving a treatment recommendation
Tidsramme: 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
Tidsramme: 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.
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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.

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

The Belgian Society of Medical Oncology

Etterforskere

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

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

22. oktober 2025

Primær fullføring (Antatt)

1. mai 2027

Studiet fullført (Antatt)

1. april 2029

Datoer for studieregistrering

Først innsendt

19. desember 2025

Først innsendt som oppfylte QC-kriteriene

16. juli 2026

Først lagt ut (Faktiske)

20. juli 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

20. juli 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

16. juli 2026

Sist bekreftet

1. januar 2026

Mer informasjon

Begreper knyttet til denne studien

Andre studie-ID-numre

  • BSMO 2024-1

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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