NCT07713550 The Added Value of Tissue or Liquid Biopsy NGS Profiling in Advanced Solid Tumor Treatment Decisions.
| NCT ID | NCT07713550 |
| Status | Recruiting |
| Phase | — |
| Sponsor | The Belgian Society of Medical Oncology |
| Condition | Advanced Solid Tumor Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 550 participants |
| Start Date | 2025-10-22 |
| Primary Completion | 2027-05 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 550 participants in total. It began in 2025-10-22 with a primary completion date of 2027-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Contact & Investigator
Philippe Aftimos, Oncologist
STUDY CHAIR
Jules Bordet Institute
Frequently Asked Questions
Who can join the NCT07713550 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Advanced Solid Tumor Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07713550 currently recruiting?
Yes, NCT07713550 is actively recruiting participants. Contact the research team at Julie.Maetens@sciensano.be for enrollment information.
Where is the NCT07713550 trial being conducted?
This trial is being conducted at Anderlecht, Belgium, Antwerp, Belgium, Bonheiden, Belgium, Brasschaat, Belgium and 10 additional locations.
Who is sponsoring the NCT07713550 clinical trial?
NCT07713550 is sponsored by The Belgian Society of Medical Oncology. The principal investigator is Philippe Aftimos, Oncologist at Jules Bordet Institute. The trial plans to enroll 550 participants.
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