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.
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
550
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)
Institute Jules Bordet
Anderlecht, Belgium
RECRUITINGZAS
Antwerp, Belgium
RECRUITINGImelda
Bonheiden, Belgium
RECRUITINGAZ Klina
Brasschaat, Belgium
RECRUITINGUniversitaire Ziekenhuis Antwerpen
Edegem, Belgium
RECRUITINGUZ Gent
Ghent, Belgium
RECRUITINGGHDC
Gilly, Belgium
RECRUITINGJessa Ziekenhuis
Hasselt, Belgium
RECRUITINGUZ Brussel
Jette, Belgium
RECRUITINGUZ Leuven
Leuven, Belgium
RECRUITING...and 4 more locations
Distribution of ESCAT Actionability Levels Identified by Comprehensive Genomic Profiling
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.
Time frame: Through study completion, an average of 1 year.
Distribution of Genomic Alteration Types Identified by Comprehensive Genomic Profiling
The reported values represent the prevalence of genomic alterations according to altered gene, type of variant of tumor type.
Time frame: Through study completion, an average of 1 year.
Number of patients receiving a treatment recommendation
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.
Time frame: Through study completion, an average of 1 year.
% of uptake of the MTB recommendations
The reported results will measure the % of patients, with at least 1 MTB recommendation, who initiated the recommended treatment.
Time frame: Through study completion, an average of 1 year.
Treatment recommendations quality.
The reported results will show a qualitative and quantitative descriptive analysis of treatment recommendations proposed by the MTB.
Time frame: Through study completion, an average of 1 year.
Participants whose treatment differed from the Molecular Tumor Board recommendation
The reported results will show a descriptive analysis of reasons for discordance between actual treatment and MTB recommendations.
Time frame: Through study completion, an average of 1 year.
Participants with turnaround time within 28 days
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).
Time frame: Through study completion, an average of 1 year.
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