Solid TumorBALLETTNCT05058937
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
A study testing Comprehensive genomic profiling in people with Solid Tumor and Metastatic Cancer, run by The Belgian Society of Medical Oncology at 12 sites in Belgium.
Trial summary
The project, called "BALLETT" (Belgian Approach of Local Laboratory Extensive Tumor Testing), has a double goal: (1) show the relevance of broad molecular profiling to improve oncological patients care, (2) demonstrate that broad molecular testing can be performed in a decentralized setting by local diagnostics… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor, Metastatic Cancer
- What is being tested?
- Comprehensive genomic profiling
- How many people
- 936 participants
- Where
- 12 sitesBelgium
- Study dates
- 1 Jun 2021to May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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").
Trial locations and contacts
12 sites in 1 country.
Gordana Raicevic Toungouz contact
12 sites in 1 country
Belgium12 sites, 12 recruiting
- Not yet recruiting
ASZ Aalst
Aalst
Max Schreuer, Max.Schreuer@asz.be
Max Schreuer
- Not yet recruiting
ZNA
Antwerp, 2020
Joke van Gaelen, ctuklinischestudies@zna.be
Joanna Vermeij, Dr
- Recruiting
GZA
Antwerp, 2610
Jo Horemans, +32 3 443 37 59, jo.horemans@gza.be
Annemie Rutten, Dr
- Recruiting
AZ Sint-Jan
Bruges
Lies Pottel, ctc@azsintjan.be
Jacques Van Huysse
- Not yet recruiting
AZ VUB
Brussels, 1090
Vanessa Fastenaekels, +32 2 474 94 78, Vanessa.Fastenaekels@uzbrussel.be
Malika Tahiri, +32 2 474 94 78, Malika.Tahiri@uzbrussel.be
- Not yet recruiting
Grand Hôpital de Charleroi
Charleroi, 6000
Stéphanie Warnon, +32 71 10 47 47, Stephanie.WARNON@ghdc.be
Jean-Luc Canon, Dr
- Recruiting
Universitaire Ziekenhuis Antwerpen
Edegem, 2650
Julia Lenaerts, julia.lenaerts@uza.be
Hans Prenen, Dr
- Not yet recruiting
UZ Gent
Ghent, 9000
Lore Vansteelant, Lore.Vansteelant@uzgent.be
Sylvie Rottey, Prof. Dr
- Recruiting
Jessa Ziekenhuis
Hasselt, 3500
Ann Tullen, +32 11 33 79 91, ann.tullen@jessazh.be
Jeroen Mebis, Prof. Dr
- Not yet recruiting
UZ Leuven
Leuven, 3000
Isabelle Vanden Bempt, isabelle.vandenbempt@uzleuven.be
Sabine Tejpar, Prof. Dr
- Recruiting
AZ Delta
Roeselare
Sophie Adriaens, sophie.adriaens@azdelta.be
Francesca Dedeurwaerdere, Dr
- Recruiting
AZ Turnhout
Turnhout
Lynn Decoster
lynn.decoster@azturnhout.be
About this study
Official title: 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)
The project, called "BALLETT" (Belgian Approach of Local Laboratory Extensive Tumor Testing), has a double goal: (1) show the relevance of broad molecular profiling to improve oncological patients care, (2) demonstrate that broad molecular testing can be performed in a decentralized setting by local diagnostics laboratories in a fully standardized and uniform way while complying with the highest quality standards.
This 2-year study involves the consortium of 9 cooperating Belgian NGS laboratories and will enroll 936 metastatic or locally advanced cancer patients coming from 13 different Belgian hospitals and cancer centers. Upon inclusion, all cancer patients will be offered 'comprehensive genomic profiling' (CGP) using Illumina's TSO500 NGS panel. This targeted NGS panel of 523 genes allows for the detection of single nucleotide variants, small indels, copy number variations and fusions, as well as for the determination of the 'tumor mutational burden' (TMB) and the 'microsatellite-instability' status (MSI). Both the wet lab execution of the CGP as well as the biological and clinical classification of the variants will be performed in a fully standardized way among the 9 participating Belgian local NGS laboratories.
Read more
The CGP results will be interpreted and discussed in the weekly meeting of the BALLETT national molecular tumor board (MTB), composed of oncologists, pathologists, molecular biologists, geneticists and bioinformaticians. The MTB will provide recommendations for targeted or immunotherapy based on the CGP results. Clinical Decision Support platforms OncoKDM (OncoDNA) and Clinical Genomics Workspace (PierianDx), both expert software that turns NGS data into actionable clinical information, will be used. The resulting therapy recommendation may consist of an approved therapy, a clinical trial, a medical need program or off-label use of cancer drugs. Treating physicians will receive the MTB recommendations and decide on the actual management of their patients. Reasons for not following the MTB recommendation will be registered.
The objectives of the project are:
- To evaluate the clinical value of CGP in "real-world" practice in giving patients with advanced/metastatic solid tumours broader access to precision medicine
- To describe the landscape of genomic alterations and quantify the actionable variants detected by comprehensive panel testing
- To evaluate the number of actionable variants that would have been missed if the NGS analysis was limited to the reimbursed NGS panel (ComPerMed panel).
- To assess the technical success of CGP
- To standardize CGP data analysis, clinical interpretation, therapy recommendation and reporting among participating laboratories to the highest extent possible
- To describe and to quantify the uptake of treatments and the inclusion in clinical trials recommended by the molecular tumour board guided by the CGP
- To assess clinical benefit by calculating PFS ratio for individual patients (PFS on CGP-selected therapy/PFS on prior therapy) (null hypothesis: ≤ 15% of patient population has PFS ratio of ≥ 1.3)
- To work in a multi-stakeholder approach to attract more innovative treatments and clinical trials in Belgium
- To establish a Belgian genomic tumor database under the authority of the governmental 'Sciensano' thereby increasing public health knowledge in Belgium
- Conditions
- Solid Tumor, Metastatic Cancer
- Being tested
- Comprehensive genomic profiling
- Keywords
- Comprehensive genomic profiling, Next generation sequencing, Tumor mutational burden, Mircosatellite instability, Molecular tumor board, Targeted therapy, Immunotherapy, Actionable variants
- Medical subject headings
- Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comprehensive genomic profilingDiagnostic test
TSO500 (523 genes + MTB + MSI)
What is being measured
The primary outcome is the main question the study is designed to answer.
Number/prevalence of variants with clinical significance
Number/prevalence of variants with a classification of clinical significance Tier 1A or 1B (strong clinical significance) and Tier 2C and 2D (potential clinical significance) using CGP versus local NGS testing (if available) and/or versus minimally required ComPerMed panel.
Tiering according to Li et al. AMP/ASCO/CAP. J Mol Diagn 19:4-23, 2017.
Measured: through study completion, an average of 1 year
Number/prevalence of alterations by type (SNVs, CNVs, fusions)
Measured: through study completion, an average of 1 year
Description of patient journey
Percentage of patients with MTB recommendation categorized according to variant-therapy match scoring system, percentage of patients accessing genotype-informed treatment, turnaround time from CGP request to MTB recommendation, proportion of patients accessing molecular guided therapy or immune checkpoint inhibitors or combinations based on the result of CGP, timing of treatment initiation following MTB recommendation, proportion of deviations from treatment recommendations and reasons (rapid clinical deterioration, other protocol, patient ineligible, off-label treatment unavailable, clinical trial not feasible (e.g. physical distance), clinical trial not recruiting, physician's decision, patient's choice, …)
Measured: through study completion, an average of 1 year
Secondary outcomes (3)
Percentage of patients with successful CGP
Measured: through study completion, an average of 1 year
PFS ratio
PFS based on RECIST 1.1 evaluation of patients on the CGP recommended therapy and PFS ratio (PFS on CGP-selected therapy/PFS on prior therapy) (null hypothesis: ≤ 15% of patient population has PFS ratio of ≥ 1.3)
Measured: through study completion, an average of 1 year
Number of participating NGS laboratories continuing CGP after the study
Including cost calculation and reimbursement data to support economic analysis (microcosting from the lab perspective and budget impact from the payer's perspective).
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2021
- Study start1 Jun 2021
- Primary completionMay 2023 (estimated)
- Study completionMay 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 936 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Belgian Society of Medical Oncology
- Sponsor type
- University, hospital or other
- Collaborators
- Illumina, Inc., OncoDNA, PierianDx
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05058937
- Sponsor's protocol ID
- BSMO2020-2
- Acronym
- BALLETT
- Status last verified
- Sep 2021
- First submitted
- 6 Sep 2021
- Last updated
- 28 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT05058937
- Acronym / sponsor ID
- BALLETT / BSMO2020-2
- Conditions
- Solid Tumor, Metastatic Cancer
- Keywords
- Comprehensive genomic profiling, Next generation sequencing, Tumor mutational burden, Mircosatellite instability, Molecular tumor board, Targeted therapy, Immunotherapy, Actionable variants
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 936 participants (estimated)
- Lead sponsor
- The Belgian Society of Medical OncologyUniversity, hospital or other
- Collaborators
- Illumina, Inc., OncoDNA, PierianDx
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- May 2023 (estimated)
- Study completion
- May 2026 (estimated)
- First posted
- 28 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The project, called "BALLETT" (Belgian Approach of Local Laboratory Extensive Tumor Testing), has a double goal: (1) show the relevance of broad molecular profiling to improve oncological patients care, (2) demonstrate that broad molecular testing can be performed in a decentralized setting by local diagnostics laboratories in a fully standardized and uniform way while complying with the highest quality standards.
This 2-year study involves the consortium of 9 cooperating Belgian NGS laboratories and will enroll 936 metastatic or locally advanced cancer patients coming from 13 different Belgian hospitals and cancer centers. Upon inclusion, all cancer patients will be offered 'comprehensive genomic profiling' (CGP) using Illumina's TSO500 NGS panel. This targeted NGS panel of 523 genes allows for the detection of single nucleotide variants, small indels, copy number variations and fusions, as well as for the determination of the 'tumor mutational burden' (TMB) and the 'microsatellite-instability' status (MSI). Both the wet lab execution of the CGP as well as the biological and clinical classification of the variants will be performed in a fully standardized way among the 9 participating Belgian local NGS laboratories.
The CGP results will be interpreted and discussed in the weekly meeting of the BALLETT national molecular tumor board (MTB), composed of oncologists, pathologists, molecular biologists, geneticists and bioinformaticians. The MTB will provide recommendations for targeted or immunotherapy based on the CGP results. Clinical Decision Support platforms OncoKDM (OncoDNA) and Clinical Genomics Workspace (PierianDx), both expert software that turns NGS data into actionable clinical information, will be used. The resulting therapy recommendation may consist of an approved therapy, a clinical trial, a medical need program or off-label use of cancer drugs. Treating physicians will receive the MTB recommendations and decide on the actual management of their patients. Reasons for not following the MTB recommendation will be registered.
The objectives of the project are:
- To evaluate the clinical value of CGP in "real-world" practice in giving patients with advanced/metastatic solid tumours broader access to precision medicine
- To describe the landscape of genomic alterations and quantify the actionable variants detected by comprehensive panel testing
- To evaluate the number of actionable variants that would have been missed if the NGS analysis was limited to the reimbursed NGS panel (ComPerMed panel).
- To assess the technical success of CGP
- To standardize CGP data analysis, clinical interpretation, therapy recommendation and reporting among participating laboratories to the highest extent possible
- To describe and to quantify the uptake of treatments and the inclusion in clinical trials recommended by the molecular tumour board guided by the CGP
- To assess clinical benefit by calculating PFS ratio for individual patients (PFS on CGP-selected therapy/PFS on prior therapy) (null hypothesis: ≤ 15% of patient population has PFS ratio of ≥ 1.3)
- To work in a multi-stakeholder approach to attract more innovative treatments and clinical trials in Belgium
- To establish a Belgian genomic tumor database under the authority of the governmental 'Sciensano' thereby increasing public health knowledge in Belgium
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Comprehensive genomic profilingTSO500 (523 genes + MTB + MSI) | Diagnostic test | – |
Primary outcome
Number/prevalence of variants with clinical significance
Time frame: through study completion, an average of 1 year
Number/prevalence of variants with a classification of clinical significance Tier 1A or 1B (strong clinical significance) and Tier 2C and 2D (potential clinical significance) using CGP versus local NGS testing (if available) and/or versus minimally required ComPerMed panel. Tiering according to Li et al. AMP/ASCO/CAP. J Mol Diagn 19:4-23, 2017.
Number/prevalence of alterations by type (SNVs, CNVs, fusions)
Time frame: through study completion, an average of 1 year
Description of patient journey
Time frame: through study completion, an average of 1 year
Percentage of patients with MTB recommendation categorized according to variant-therapy match scoring system, percentage of patients accessing genotype-informed treatment, turnaround time from CGP request to MTB recommendation, proportion of patients accessing molecular guided therapy or immune checkpoint inhibitors or combinations based on the result of CGP, timing of treatment initiation following MTB recommendation, proportion of deviations from treatment recommendations and reasons (rapid clinical deterioration, other protocol, patient ineligible, off-label treatment unavailable, clinical trial not feasible (e.g. physical distance), clinical trial not recruiting, physician's decision, patient's choice, …)
3 secondary outcomes
Percentage of patients with successful CGP
Time frame: through study completion, an average of 1 year
PFS ratio
Time frame: through study completion, an average of 1 year
Number of participating NGS laboratories continuing CGP after the study
Time frame: through study completion, an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gordana Raicevic Toungouz contact
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Comprehensive genomic profiling in people with Solid Tumor and Metastatic Cancer, run by The Belgian Society of Medical Oncology at 12 sites in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Brigitte Maes, Dr (+32 11 33 83 41, Brigitte.Maes@jessazh.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number/prevalence of variants with clinical significance (time frame: through study completion, an average of 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2021.