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

NCT04641676 | Unknown

• 1 other identifier: BSMO2020-1
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 12

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. 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. 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. 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. 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. 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.
6. 6.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.
7. 7.To describe the landscape of genomic alterations detected by reimbursed NGS
8. 8.To describe he landscape of genomic alterations detected by comprehensive panel testing
9. 9.To assess the technical success of comprehensive panel testing
10. 10.To describe the uptake of treatments recommended by the molecular tumor board guided by the genomic testing.

Conditions

Metastatic Cancer; Local Tumor Invasion

Outcome Measures

Primary Outcomes (3)

• 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.

  through study completion, an average of 1 year

• Number/prevalence of alterations by type using Foundation Medicine testing. Descriptive results will also be presented by tumor type.

  through study completion, an average of 1 year

• Percentage of patients with successful comprehensive panel testing

  through study completion, an average of 1 year

Secondary Outcomes (2)

• Prevalence of level 1, 2, 3 and 4 alterations as per OncoKB detected using liquid biopsies.

  through study completion, an average of 1 year

• Percentage of patients with a treatment recommandation based on a liquid biopsy

  through study completion, an average of 1 year

Study Arms (3)

Foundation medicine NGS in parallel with local NGS

OTHER

The patient will have in parallel FMI NGS test and Local reimbursed NGS test.

Diagnostic Test: NGS testing

Foundation Medicine NGS

OTHER

The patient will have only FMI NGS test.

Diagnostic Test: NGS testing

LB Foundation Medicine NGS test

EXPERIMENTAL

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

Interventions

NGS testing DIAGNOSTIC_TEST

NGS test will be performed

Foundation Medicine NGS; Foundation medicine NGS in parallel with local NGS; LB Foundation Medicine NGS test

Eligibility Criteria

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

You may qualify if:

• Adult patients (18 years and above)
• 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.
• 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.
• 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.
• Patient showing an Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 2.
• 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).
• Patients able to provide written informed consent prior to enrollment into a potential subsequent clinical trial.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Belgian Society of Medical Oncology: lead
• Foundation Medicine: collaborator
• Sciensano: collaborator
• Roche Pharma AG: collaborator

Study Sites (12)

ZNA

Antwerp, 2020, Belgium

RECRUITING

GZA

Antwerp, 2610, Belgium

NOT YET RECRUITING

AZ Klina

Brasschaat, 2930, Belgium

RECRUITING

Institute Jules Bordet

Brussels, 1000, Belgium

RECRUITING

AZ VUB

Brussels, 1090, Belgium

RECRUITING

Les Cliniques Universitaires St Luc

Brussels, 1200, Belgium

RECRUITING

Grand Hôpital de Charleroi

Charleroi, 6000, Belgium

RECRUITING

Universitaire Ziekenhuis Antwerpen

Edegem, 2650, Belgium

RECRUITING

UZ Gent

Ghent, 9000, Belgium

RECRUITING

Jessa Ziekenhuis

Hasselt, 3500, Belgium

NOT YET RECRUITING

CHU Sart-Tilman

Liège, 4000, Belgium

RECRUITING

AZ Nikolaas

Sint-Niklaas, 9100, Belgium

NOT YET RECRUITING

MeSH Terms

Conditions

Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Maïté de Hemptinne

CONTACT

+32 4 74 56 73 88; maite.dehemptinne@sciensano.be

Gordana Raicevic Toungouz

CONTACT

+32 4 76 97 34 06; Gordana.RaicevicToungouz@sciensano.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 28, 2020
• First Posted: November 24, 2020
• Study Start: October 9, 2020
• Primary Completion: September 15, 2022
• Study Completion: December 31, 2022
• Last Updated: May 28, 2021

Record last verified: 2021-05

Locations

BE (12)