The Added Value of Tissue or Liquid Biopsy NGS Profiling in Advanced Solid Tumor Treatment Decisions.
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorThe Belgian Society of Medical Oncology
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adult patient (minimum 18 years) able to provide written informed consent for GeNeo 2.0.
ECOG Performance status ≤2
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.
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%
Disqualifiers
Life expectancy of ≤12 weeks according to the local investigator
Clinically significant hematopoietic, renal and/or hepatic dysfunction, according to the local investigator, which would make them ineligible for MGTO therapy
Patients unwilling to comply with GeNeo 2.0 protocol data collection, data sharing and other study procedures
Patients unwilling to provide informed consent and comply with study procedures.
Trial population
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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Comprehensive NGS testing
Diagnostic testTo 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)
Treatment groups
550 Participants
are divided into 1 treatment groupGroup A: Agnostic cohort1 intervention
Trial outcomes
Primary outcomes
1
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.2
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.Secondary outcomes
1
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.2
% 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.3
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.4
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.Sponsors and contacts
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Source ClinicalTrials.gov