NCT03873103

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 1,000 (estimated)
• Sponsor: The Belgian Society of Medical Oncology · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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").

Conditions

• Metastatic Cancer

Timeline

• Start date: 2019-03-31
• Primary completion: 2023-12-31
• Completion: 2023-12-31
• First posted: 2019-03-13
• Last updated: 2021-06-01

Locations

10 sites across 1 country: Belgium