Clinical trial NCT03873103: The Belgian Molecular Profiling Program of Metastatic Cancer for Clinical Decision and Treatment Assignment
Official title: The Belgian Molecular Profiling Program of Metastatic Cancer for Clinical Decision and Treatment Assignment - Precision 1
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Metastatic Cancer
Lead sponsor: The Belgian Society of Medical Oncology
Sponsor class: OTHER
First posted: 2019-03-13
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
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.

Brief 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").


Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of patients with "actionable" driven mutations.
timeFrame: 18 months
measure: Percentage of patients enrolled in genomics-driven clinical trials and in the PRECISION 2 clinical trial.
timeFrame: 18 months
measure: 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
timeFrame: 18 months
Secondary outcomes:
Other outcomes:
Locations:
city: Antwerp
country: Belgium
facility: ZNA
city: Antwerp
country: Belgium
facility: GZA
city: Brasschaat
country: Belgium
facility: AZ Klina
city: Brussels
country: Belgium
facility: Institute Jules Bordet
city: Brussels
country: Belgium
facility: AZ VUB
city: Brussels
country: Belgium
facility: Les Cliniques Universitaires St Luc
city: Edegem
country: Belgium
facility: Universitaire Ziekenhuis Antwerpen
city: Gent
country: Belgium
facility: UZ Gent
city: Liège
country: Belgium
facility: CHU Sart-Tilman
city: Sint-Niklaas
country: Belgium
facility: AZ Nikolaas
Study officials:
affiliation: Institute Jules Bordet
name: Philippe Aftimos, Dr
role: PRINCIPAL_INVESTIGATOR
References: