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
Qualifiers
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 design
Treatments tested in this trial
- Comprehensive NGS testing
Treatment groups
550 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov