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NCT03873103

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

Status unknown Last updated 1 June 2021
What this trial tests

trial in Metastatic Cancer in 1,000 participants. Status unknown.

Timeline
31 March 2019
Primary endpoint
31 December 2023
31 December 2023

Quick facts

Lead sponsorThe Belgian Society of Medical Oncology
StatusStatus unknown
Study typeOBSERVATIONAL
Enrollment1,000
Start date31 March 2019
Primary completion31 December 2023
Estimated completion31 December 2023
Sites10 locations across Belgium

Conditions studied

Sponsor

The Belgian Society of Medical Oncology

Who can join

Adults 18 to 80, any sex, with Metastatic Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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").

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. PRECISION: the Belgian molecular profiling program of metastatic cancer for clinical decision and treatment assignment.
    Thouvenin J, Van Marcke C, Decoster L, Raicevic G, et al · · 2022 · cited 10× · PMID 35970014 · DOI 10.1016/j.esmoop.2022.100524

Verify or expand the search:

Other recruiting trials for Metastatic Cancer

Currently open trials in the same condition.

Other The Belgian Society of Medical Oncology trials

Trials by the same sponsor.

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Data sources for this page

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