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A Study to Examine the Value of Broad Agnostic Next Generation Sequencing (NGS) Panel Testing Versus Reimbursed Organ-directed NGS: a Belgian Precision Study of the BSMO in Collaboration With the Cancer Center

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ClinicalTrials.gov Identifier: NCT04641676
Recruitment Status : Recruiting
First Posted : November 24, 2020
Last Update Posted : May 28, 2021
Sponsor:
Collaborators:
Foundation Medicine
Sciensano
Roche Pharma AG
Information provided by (Responsible Party):
The Belgian Society of Medical Oncology

Brief Summary:

Title of the study A study to examine the value of broad agnostic NGS panel testing versus reimbursed organ-directed NGS: a Belgian Precision study of the BSMO in collaboration with the Cancer Centre Study Number BSMO 2020-1 Study Phase Exploratory Sponsor Belgian Society of medical Oncology (BSMO) Treatment None Background and Rationale Several drugs targeting mutated gene products in cancer cells are available to Belgian patients through reimbursement of the drugs and, soon, by reimbursed organ-specific genomic testing.

This context is unfavorable with regard to the following issues:

  1. Many more additional drugs with sound scientific rationale and preclinical evidence are available through clinical trials. The relevant genes are generally not included in the reimbursed NGS and ad hoc identification of such patients is extremely difficult and thus severely hampering the accrual in such trials. This denies patients a potential access to innovative treatments from which they could benefit and hampers progress.
  2. The same genes can be mutated in other cancer types, other than the reimbursed context, but are not detected due to the organ-specific approach in reimbursed NGS. Examination of these genes with an agnostic approach would give these other patients potential access to the drugs (via various routes, including clinical trials or medical need or otherwise)
  3. The broader panels applied by some Belgian platforms (50-100 genes), sometimes in an agnostic approach, do not cover all potentially actionable genes or not all types of actionable variants in these genes.
  4. Rearrangements which are highly actionable are not systematically covered in NGS testing, but rely on immunohistochemistry (if done at all) of fusion panels testing that requires additional funding.
  5. The various Belgian NGS labs use accredited but heterogeneous methodology and it has been reported that the detection rate of some mutations varies from one site to another.

Therefore, from a patient and oncologist point of view there are current deficiencies that jeopardize optimal access of patients to current or novel genome-driven therapies. Defective identification of sensitive patients limits the implementation of clinical trials and their accrual rates and therefore the attractiveness of Belgium for such trials.

There are more comprehensive commercial platforms that cover a large set of actionable genes (up to hundreds of genes) and the various types of mutations in these genes: sequence mutations, rearrangements, resulting in fusion genes, and gene amplifications.

These commercial vendors have adequate comprehensive methodology but are too expensive (at their current public pricing) for general application. One of these is the platform of Foundation Medicine that builds on a large experience in variant annotation in the US and includes probably all current actionable targets including gene mutations, fusions, MSI, and TMB, all at once in one result. They also report actionability and established or clinical trial treatment options.

To oncologists this is very attractive compared to the fragmented, sequential and very limited current reimbursed conditions.

The investigators estimate that up to 20% of advanced cancer patients could get access to genotype-based treatment that are not covered by the organ-based reimbursement based access to NGS. This can be in the form of off-label application of reimbursed drugs, pharma-sponsored drug development trials that address a specific genotype or pharma sponsored or academic basket trials. Without broad agnostic testing the identification of eligible patients remains extremely difficult. A recent study [A study of genetic characteristics and suitability for targeted cancer treatment (TARGET)] showed that the rate of detection of actionable mutations increased from 28% with local testing to 66% with Foundation Medicine testing.

Objectives

  1. To determine the added value of comprehensive and agnostic NGS versus "real-world" practice ("real-world" practice means local testing, no reimbursement for local testing and/or no accessible metastatic lesion) in providing patients with advanced/metastatic solid tumors access molecular guided therapy and/or immunotherapy based on genomic results.
  2. To describe the landscape of genomic alterations detected by reimbursed NGS
  3. To describe he landscape of genomic alterations detected by comprehensive panel testing
  4. To assess the technical success of comprehensive panel testing
  5. To describe the uptake of treatments recommended by the molecular tumor board guided by the genomic testing.

Condition or disease Intervention/treatment Phase
Metastatic Cancer Local Tumor Invasion Diagnostic Test: NGS testing Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1000 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: A Study to Examine the Value of Broad Agnostic NGS Panel Testing Versus Reimbursed Organ-directed NGS: a Belgian Precision Study of the BSMO in Collaboration With the Cancer Center
Actual Study Start Date : October 9, 2020
Estimated Primary Completion Date : September 15, 2022
Estimated Study Completion Date : December 31, 2022

Arm Intervention/treatment
Foundation medicine NGS in parallel with local NGS
The patient will have in parallel FMI NGS test and Local reimbursed NGS test.
Diagnostic Test: NGS testing
NGS test will be performed

Foundation Medicine NGS
The patient will have only FMI NGS test.
Diagnostic Test: NGS testing
NGS test will be performed

Experimental: LB Foundation Medicine NGS test
The patient do not have enough biopsy material or have tumor not accessible for a biopsy will have a liquid biopsy Foundation Medicine test.
Diagnostic Test: NGS testing
NGS test will be performed




Primary Outcome Measures :
  1. Number/prevalence of level 1, 2, 3 and 4 alterations as per OncoKB using comprehensive panel testing versus "real-word" practice in the three cohorts included. [ Time Frame: through study completion, an average of 1 year ]
  2. Number/prevalence of alterations by type using Foundation Medicine testing. Descriptive results will also be presented by tumor type. [ Time Frame: through study completion, an average of 1 year ]
  3. Percentage of patients with successful comprehensive panel testing [ Time Frame: through study completion, an average of 1 year ]

Secondary Outcome Measures :
  1. Prevalence of level 1, 2, 3 and 4 alterations as per OncoKB detected using liquid biopsies. [ Time Frame: through study completion, an average of 1 year ]
  2. Percentage of patients with a treatment recommandation based on a liquid biopsy [ Time Frame: through study completion, an average of 1 year ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 1- Adult patients (18 years and above)
  • 2- Patients with metastatic solid tumors that are candidates for systemic therapy (early lines are preferred). Numbers will be capped for frequent tumor types (breast cancer: 150 patients, NSCLC: 150 patients, colorectal cancer: 150 patients). There will be a cohort of 200 patients with rare tumors or tumors with rare histology (Eur. J. Cancer 2011; 47: 2493-2511). Patients will be recruited as they appear in clinical practice.

    3- Patients will be enrolled following three clinical scenarios: a) patients eligible for local NGS testing (reimbursed or local practice); b) patients that are not eligible for reimbursed or local NGS testing; c) patients with no sufficient archival tissue meeting the pre-requirements will only undergo FMI liquid biopsy testing (exploratory cohort). That last cohort will be capped at 100 patients and will not have more than 50% of patients with the same tumor type.

    4- Patients enrolled in scenario a) and b) must have enough tissue from a metastatic (preferred) or primary lesion biopsy for local testing and FMI testing. The tissue should not be more than 3 years-old and fixed in 10% neutral buffered formalin. Availability of metastatic biopsies performed 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 Gastrointestinal stromal tumor (GIST)…). Bone biopsies that undergo decalcification are not allowed.

    5- Patient showing an Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 2.

    6- Patients can only be enrolled if they are also concomitantly registered in the Precision 1 study and the investigator agrees to subsequent registration of genotype-driven treatments given and the investigator assessed outcome on these treatments (RR and PFS).

    7- Patients able to provide written informed consent prior to enrollment into a potential subsequent clinical trial.

Exclusion Criteria:

  • 1- Life expectancy of less than 12 weeks.
  • 2- Inability to comply with protocol procedures.
  • 3- Known presence of severe hematopoietic, renal, and/or hepatic dysfunction (according to the local PI).

    4- - No informed consent provided.

  • 5- Patient is not enrolled and followed as provided in Precision 1.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04641676


Contacts
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Contact: Maïté de Hemptinne +32 4 74 56 73 88 maite.dehemptinne@sciensano.be
Contact: Gordana Raicevic Toungouz +32 4 76 97 34 06 Gordana.RaicevicToungouz@sciensano.be

Locations
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Belgium
ZNA Recruiting
Antwerp, Belgium, 2020
Contact: Abdelbari Baitar    +32 3 280 31 30    abdelbari.baitar@zna.be   
Contact: Myriam Mertens    +32 3 280 31 30    myriam.mertens@zna.be   
Principal Investigator: Joanna Vermeij, Dr         
GZA Not yet recruiting
Antwerp, Belgium, 2610
Contact: Jo Horemans    +32 3 443 37 59    jo.horemans@gza.be   
Principal Investigator: Luc Dirix, Dr         
AZ Klina Recruiting
Brasschaat, Belgium, 2930
Contact: Charis Loos    +32 3 650 53 99    Charis.Loos@klina.be   
Principal Investigator: Wim Demey, Dr         
Institute Jules Bordet Recruiting
Brussels, Belgium, 1000
Contact: Fanny Bustin    +32 2 541 32 20    fanny.bustin@bordet.be   
Contact: Sylvie Bartholomeus    +32 2 541 32 20    sylvie.bartholomeus@bordet.be   
Principal Investigator: Philippe Aftimos, Dr         
AZ VUB Recruiting
Brussels, Belgium, 1090
Contact: Vanessa Fastenaekels    +32 2 474 94 78    Vanessa.Fastenaekels@uzbrussel.be   
Contact: Malika Tahiri    +32 2 474 94 78    Malika.Tahiri@uzbrussel.be   
Principal Investigator: Lore Decoster, Dr         
Les Cliniques Universitaires St Luc Recruiting
Brussels, Belgium, 1200
Contact: Valérie Decroës    +32 2 764 42 97    valerie.decroes@uclouvain.be   
Principal Investigator: Cédric Van Marcke de Lummen, MD         
Grand Hôpital de Charleroi Recruiting
Charleroi, Belgium, 6000
Contact: Stéphanie Warnon    +32 71 10 47 47    Stephanie.WARNON@ghdc.be   
Contact: Matthias Papier    +32 71 10 47 47    matthias.papier@ghdc.be   
Principal Investigator: Jean-Luc Canon, Dr         
Universitaire Ziekenhuis Antwerpen Recruiting
Edegem, Belgium, 2650
Contact: Greet De Craen    +32 3 821 41 21    Greet.DeCraen@uza.be   
Principal Investigator: Marc Peeters, Dr         
UZ Gent Recruiting
Gent, Belgium, 9000
Contact: Lore Vansteelant    +32 9 332 57 93    Lore.Vansteelant@UZGENT.be   
Principal Investigator: Sylvie Rottey, PhD         
Jessa Ziekenhuis Not yet recruiting
Hasselt, Belgium, 3500
Contact: Ann Tullen    +32 11 33 79 91    ann.tullen@jessazh.be   
Principal Investigator: Jeroen Mebis, Dr         
CHU Sart-Tilman Recruiting
Liège, Belgium, 4000
Contact: Hélène Schroeder    +3243668203    hschroeder@chuliege.be   
Contact: Astrid Collinge    +3243668203    acollinge@chuliege.be   
Principal Investigator: Joelle Collignon, Dr         
AZ Nikolaas Not yet recruiting
Sint-Niklaas, Belgium, 9100
Principal Investigator: Willem Lybaert, Dr         
Sponsors and Collaborators
The Belgian Society of Medical Oncology
Foundation Medicine
Sciensano
Roche Pharma AG
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Responsible Party: The Belgian Society of Medical Oncology
ClinicalTrials.gov Identifier: NCT04641676    
Other Study ID Numbers: BSMO2020-1
First Posted: November 24, 2020    Key Record Dates
Last Update Posted: May 28, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neoplasm Metastasis
Neoplastic Processes
Neoplasms
Pathologic Processes