Added tissue or liquid biopsy profiling to guide advanced solid tumor treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

GeNeo 2.0 is an observational study enrolling up to 550 adults with metastatic solid tumors or primary CNS malignancies to profile tumors using tissue CGP and Foundation Medicine liquid biopsy (cytogenomic profiling). Central sequencing at UZ Leuven and secondary/tertiary analysis across eight labs will characterize ESCAT-level alterations and treatment-relevant genomic landscapes. The study also describes how often molecular tumor boards make treatment recommendations and how often those recommendations are acted upon, including turnaround times and testing success rates. Recruitment is across 14 Belgian centers with tumor cohorts prioritized for breast and lung cancer, and tissue availability is required for most participants.

Why it matters

Who can join: the full rules

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.

Where it's running

• Institute Jules Bordet
  Anderlecht, Belgium Recruiting
• Zas
  Antwerp, Belgium Recruiting
• Imelda
  Bonheiden, Belgium Recruiting
• AZ Klina
  Brasschaat, Belgium Recruiting
• Universitaire Ziekenhuis Antwerpen
  Edegem, Belgium Recruiting
• UZ Gent
  Ghent, Belgium Recruiting

Study contacts

• Study coordinator: Julie Maetens
• Email: Julie.Maetens@sciensano.be
• Phone: +32 2 642 54 90

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.