The Belgian Molecular Profiling Program of Metastatic Cancer for Clinical Decision and Treatment Assignment

The Belgian Molecular Profiling Program of Metastatic Cancer for Clinical Decision and Treatment Assignment - Precision 1

PRECISION 1 will enroll patients with metastatic solid tumors. The local PI will verify if the candidate patient fits the inclusion/ exclusion criteria.

The participant will sign the PRECISION 1 informed consent. NGS data will be collected from local panel testing on DNA extracted from tissue samples or plasma.

Data will be collected from further molecular testing performed at the different laboratories: select rearrangements (fusion genes and translocations) by RT PCR, FISH or NGS; copy number variations of selected genes via the NGS platform (if possible) or using FISH or other technologies such as SNP arrays in case the NGS technology is incapable of giving this information.

Results will be stored in the Precision Belgium section of the Healthdata database.

Data on germline variants will also be collected in the Healthdata database whenever this information is available.

The cooperating clinical investigator will decide with the patient the treatment strategy, -guided by the best interest of the patient and the availability of respective options :

• " Empirical " available approved treatment (for example chemotherapy, immunotherapy)
• Genotype-driven standard of care
• Inclusion in a genotype-matched clinical trial (includes signing of trial-specific IC)
• Inclusion in PRECISION 2 if options 2/3 not available. Irrespective of treatment choice, the patient will be followed by the collaborating clinician and will have follow-up data collected every 6 months for determination of disease status and survival endpoints.

Clinical data will be collected and stored in the Healthdata database. Genomic data (somatic and germline whenever available) and clinical data (tumor type and stage, number of previous lines, treatment choice, response rate, PFS on chosen and previous treatments, …) will be uploaded on the Healthdata platform and can be consulted via password-protected web access by the local PI at each participating center. European regulation protecting patient privacy will apply ("GDPR").

Study Overview

• Status: Recruiting
• Conditions: Metastatic Cancer

• Study Type: Observational
• Enrollment (Anticipated): 1000

Contacts and Locations

• Study Contact: Name: Gordana Raicevic Toungouz, PhD; Phone Number: 003226425490; Email: gordana.raicevictoungouz@sciensano.be

Study Locations

• Belgium
  • Antwerp, Belgium, 2020
    • Recruiting
    • ZNA
    • Principal Investigator: Dirk Schrijvers, Dr
  • Antwerp, Belgium, 2610
    • Recruiting
    • GZA
    • Principal Investigator: Luc Dirix, Dr
  • Brasschaat, Belgium, 2930
    • Recruiting
    • AZ Klina
    • Principal Investigator: Wim Demey, Dr
    • Contact: Charis Loos
  • Brussels, Belgium, 1000
    • Recruiting
    • Institute Jules Bordet
    • Contact: Anna-Kim Bergström
    • Principal Investigator: Philippe Aftimos, Dr
  • Brussels, Belgium, 1090
    • Recruiting
    • AZ VUB
    • Contact: Nadia Cappoen
    • Principal Investigator: Lore Decoster, Dr
  • Brussels, Belgium, 1200
    • Recruiting
    • Les Cliniques Universitaires St Luc
    • Principal Investigator: Francois Duhoux, MD
    • Contact: Matthias Papier
  • Edegem, Belgium, 2650
    • Recruiting
    • Universitaire Ziekenhuis Antwerpen
    • Principal Investigator: Marika Rasschaert, Dr
  • Gent, Belgium, 9000
    • Recruiting
    • UZ Gent
    • Contact: Lore Vansteelant
    • Principal Investigator: Sylvie Rottey, PhD
  • Liège, Belgium, 4000
    • Recruiting
    • CHU Sart-Tilman
    • Contact: Hélène Schroeder; Email: hschroeder@chuliege.be
    • Principal Investigator: Joelle Collignon, Dr
  • Sint-Niklaas, Belgium, 9100
    • Recruiting
    • AZ Nikolaas
    • Principal Investigator: Willem Lybaert, Dr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

1000 patients with metastatic solid tumors that are eligible for systemic therapy will be recruited at 7 Belgian academic centers.

Description

Inclusion Criteria:

• Patients with metastatic solid tumors that are candidates for systemic therapy (early lines are preferred).
• Patient showing an Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 2.
• Patients able to provide written informed consent prior to enrollment into a subsequent clinical trial.
• Patients agrees to provide NGS data (somatic and/or germline) as well as clinical data baseline and during follow-up.

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).
• Targeted gene sequencing on DNA extracted from decalcified bone biopsies is not accepted.

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percentage of patients with "actionable" driven mutations.	18 months
Percentage of patients enrolled in genomics-driven clinical trials and in the PRECISION 2 clinical trial.	18 months
Clinical benefit rate as defined by survival and/or objective response rate and rate of stable disease lasting more than 6 months with genomics-driven therapy in non-approved indications	18 months

Collaborators and Investigators

• Sponsor: The Belgian Society of Medical Oncology
• Investigators: Principal Investigator: Philippe Aftimos, Dr, Institute Jules Bordet

Study record dates

Study Major Dates

• Study Start (Actual): March 31, 2019
• Primary Completion (Anticipated): December 31, 2023
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: March 11, 2019
• First Submitted That Met QC Criteria: March 12, 2019
• First Posted (Actual): March 13, 2019

Study Record Updates

• Last Update Posted (Actual): June 1, 2021
• Last Update Submitted That Met QC Criteria: May 28, 2021
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplastic Processes; Neoplasms; Neoplasm Metastasis; Neoplasms, Second Primary
• Other Study ID Numbers: BSMO 2014-2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No