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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 :
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").
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| Measure | Description | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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1000 patients with metastatic solid tumors that are eligible for systemic therapy will be recruited at 7 Belgian academic centers.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Gordana Raicevic Toungouz, PhD | Contact | 003226425490 | gordana.raicevictoungouz@sciensano.be |
| Name | Affiliation | Role |
|---|---|---|
| Philippe Aftimos, Dr | Institute Jules Bordet | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ZNA | Recruiting | Antwerp | 2020 | Belgium |
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| ID | Term |
|---|---|
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D009385 | Neoplastic Processes |
| D009369 | Neoplasms |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| GZA | Recruiting | Antwerp | 2610 | Belgium |
|
| AZ Klina | Recruiting | Brasschaat | 2930 | Belgium |
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| Institute Jules Bordet | Recruiting | Brussels | 1000 | Belgium |
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| AZ VUB | Recruiting | Brussels | 1090 | Belgium |
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| Les Cliniques Universitaires St Luc | Recruiting | Brussels | 1200 | Belgium |
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| Universitaire Ziekenhuis Antwerpen | Recruiting | Edegem | 2650 | Belgium |
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| UZ Gent | Recruiting | Ghent | 9000 | Belgium |
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| CHU Sart-Tilman | Recruiting | Liège | 4000 | Belgium |
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| AZ Nikolaas | Recruiting | Sint-Niklaas | 9100 | Belgium |
|