Examining the clinical value of comprehensive genomic profiling for cancer patients in Belgium
A Study to Examine the Clinical Value of Comprehensive Genomic Profiling Performed by Belgian NGS Laboratories: a Belgian Precision Study of the BSMO in Collaboration With the Cancer Centre - Belgian Approach for Local Laboratory Extensive Tumor Testing (BALLETT)
This study is testing whether detailed genetic testing can improve treatment for cancer patients with advanced tumors in Belgium.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 936 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | The Belgian Society of Medical Oncology Academic / other |
| Drugs / interventions | immunotherapy |
| Locations | 12 sites (Aalst and 11 other locations) |
| Trial ID | NCT05058937 on ClinicalTrials.gov |
What this trial studies
This project, known as BALLETT, aims to demonstrate the importance of broad molecular profiling in enhancing the care of oncology patients. It involves a collaboration of nine Belgian NGS laboratories and will enroll 936 patients with metastatic or locally advanced solid tumors from 13 hospitals. Participants will undergo comprehensive genomic profiling using a targeted NGS panel to identify various genetic alterations and assess tumor mutational burden. The study seeks to establish that such testing can be performed effectively in a decentralized manner while adhering to high-quality standards.
Who should consider this trial
Good fit: Ideal candidates include adult patients with metastatic solid tumors who are candidates for systemic therapy and have a life expectancy of more than 12 weeks.
Not a fit: Patients with non-metastatic tumors or those who do not meet the eligibility criteria for systemic therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved personalized treatment options for cancer patients based on their unique genomic profiles.
How similar studies have performed: Other studies have shown success with similar comprehensive genomic profiling approaches, indicating a promising avenue for personalized cancer treatment.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adult patients (18 years and above) * Patients with metastatic solid tumours that are candidates for systemic therapy (early lines are preferred). Numbers will be capped for frequent tumour types (breast cancer: 120 patients, NSCLC: 120 patients, colorectal cancer: 120 patients). There will be a cohort of 150 patients with rare tumours or tumours with rare histology (Eur. J. Cancer 2011; 47: 2493-2511). Patients will be recruited as they appear in clinical practice. * Life expectancy of \> 12 weeks. * Patient showing an Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 2. * Patients eligible for reimbursed NGS (cfr. indications NGS convention) will also be tested by the local NGS panel although this is not required if the CGP is ISO 15189 accredited. In that situation, the CGP is considered the local NGS. Patients that are not eligible for reimbursed NGS testing may only be tested by CGP. * Patients must have enough tissue from a metastatic (preferred) or primary lesion biopsy for local testing and CGP testing, sufficient to extract a minimum of 80 ng DNA diluted in TE 1x and 40-80 ng (80 ng recommended) RNA diluted in RNA-grade water for TSO500 library prep. The nucleic acid extract must meet the quality requirements specified in the protocol (See "TruSight Oncology 500 (TSO500) workflow - Workflow instructions for participant laboratories"). The tissue should not be more than 2 years-old and fixed in 10% neutral buffered formalin. Availability of metastatic biopsies retrieved after a previous therapy line are mandatory for patients treated with therapies that are known to induce acquired mechanisms of resistance (EGFR TKIs in NSCLC, aromatase inhibitors in breast cancer, TKIs in GIST…). Bone biopsies that undergo decalcification are not allowed. * Patients can only be enrolled if they are also concomitantly registered in the Precision-1 study and the investigator agrees to subsequent registration of CGP-driven treatment given and the investigator assessed outcome on this and prior treatment (PFS based on RECIST 1.1 evaluation). * Patients able to provide written informed consent prior to enrolment into a potential subsequent clinical trial. Exclusion Criteria: * Life expectancy of less than 12 weeks. * Inability to comply with protocol procedures. * Known presence of severe hematopoietic, renal, and/or hepatic dysfunction (according to the local PI). * No informed consent provided. * Patient is not enrolled and followed as provided in Precision-1. * Insufficient DNA/RNA quantity (\<80 ng DNA, \<40-80 ng RNA) and quality (dCq value \>5 for DNA, DV200 value \<20% for RNA), (See "TruSight Oncology 500 (TSO500) workflow - Workflow instructions for participant laboratories").
Where this trial is running
Aalst and 11 other locations
- ASZ Aalst — Aalst, Belgium (Not_yet_recruiting)
- Zna — Antwerp, Belgium (Not_yet_recruiting)
- Gza — Antwerp, Belgium (Recruiting)
- AZ Sint-Jan — Bruges, Belgium (Recruiting)
- Az Vub — Brussels, Belgium (Not_yet_recruiting)
- Grand Hôpital de Charleroi — Charleroi, Belgium (Not_yet_recruiting)
- Universitaire Ziekenhuis Antwerpen — Edegem, Belgium (Recruiting)
- UZ Gent — Ghent, Belgium (Not_yet_recruiting)
- Jessa Ziekenhuis — Hasselt, Belgium (Recruiting)
- UZ Leuven — Leuven, Belgium (Not_yet_recruiting)
- AZ Delta — Roeselare, Belgium (Recruiting)
- AZ Turnhout — Turnhout, Belgium (Recruiting)
Study contacts
- Study coordinator: Brigitte Maes, Dr
- Email: Brigitte.Maes@jessazh.be
- Phone: +32 11 33 83 41
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.