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

NCT07713550 | Recruiting

• 1 other identifier: BSMO 2024-1
• Study Type: observational
• Target: 550
• Locations: 1 country
• Sites: 14

Brief Summary

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.

Conditions

Advanced Solid Tumor Cancer; Primary CNS Tumors

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Through study completion, an average of 1 year.

Secondary Outcomes (5)

• Number of patients receiving a treatment recommendation

  Through study completion, an average of 1 year.

• % of uptake of the MTB recommendations

  Through study completion, an average of 1 year.

• Treatment recommendations quality.

  Through study completion, an average of 1 year.

• Participants whose treatment differed from the Molecular Tumor Board recommendation

  Through study completion, an average of 1 year.

• Participants with turnaround time within 28 days

  Through study completion, an average of 1 year.

Study Arms (1)

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.

Diagnostic Test: Comprehensive NGS testing

Interventions

Comprehensive NGS testing DIAGNOSTIC_TEST

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)

Agnostic cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study 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.

You may qualify if:

• 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%

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Belgian Society of Medical Oncology: lead

Study Sites (14)

Institute Jules Bordet

Anderlecht, 1070, Belgium

RECRUITING

ZAS

Antwerp, 2030, Belgium

RECRUITING

Imelda

Bonheiden, 2820, Belgium

RECRUITING

AZ Klina

Brasschaat, 2930, Belgium

RECRUITING

Universitaire Ziekenhuis Antwerpen

Edegem, 2650, Belgium

RECRUITING

UZ Gent

Ghent, 9000, Belgium

RECRUITING

GHDC

Gilly, 6060, Belgium

RECRUITING

Jessa Ziekenhuis

Hasselt, 3500, Belgium

RECRUITING

UZ Brussel

Jette, 1090, Belgium

RECRUITING

UZ Leuven

Leuven, 3000, Belgium

RECRUITING

CHU Liège Sart Tilman

Liège, 4000, Belgium

RECRUITING

CHU UCL Namur

Namur, 5000, Belgium

RECRUITING

VITAZ

Sint-Niklaas, 9100, Belgium

RECRUITING

Les Cliniques Universitaires St Luc

Woluwe-Saint-Lambert, 1200, Belgium

RECRUITING

Study Officials

• Philippe Aftimos, Oncologist

  Jules Bordet Institute

  STUDY CHAIR

• Kevin Punie, Oncologist

  ZAS

  STUDY CHAIR

• Jacques de Grève, Oncologist

  Universitair Ziekenhuis Brussel

  STUDY CHAIR

Central Study Contacts

Julie Maetens

CONTACT

+32 2 642 54 90; Julie.Maetens@sciensano.be

Gordana RaicevicToungouz

CONTACT

+32 2 642 54 90; Gordana.RaicevicToungouz@sciensano.be

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2025
• First Posted: July 20, 2026
• Study Start: October 22, 2025
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): April 1, 2029
• Last Updated: July 20, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

BE (14)