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

Metastatic Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03873103
• Other study ID #: BSMO 2014-2
• Status: Recruiting
• Start date: March 31, 2019
• Est. completion date: December 31, 2023

Study information

• Verified date: December 2020
• Source: The Belgian Society of Medical Oncology
• Contact: Gordana Raicevic Toungouz, PhD
• Phone: 003226425490
• Email: gordana.raicevictoungouz[@]sciensano.be
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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").

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Metastatic Cancer
• Neoplasm Metastasis
• Neoplasms
• Neoplasms, Second Primary

Locations

Country	Name	City	State
Belgium	GZA	Antwerp
Belgium	ZNA	Antwerp
Belgium	AZ Klina	Brasschaat
Belgium	AZ VUB	Brussels
Belgium	Institute Jules Bordet	Brussels
Belgium	Les Cliniques Universitaires St Luc	Brussels
Belgium	Universitaire Ziekenhuis Antwerpen	Edegem
Belgium	UZ Gent	Gent
Belgium	CHU Sart-Tilman	Liège
Belgium	AZ Nikolaas	Sint-Niklaas

Sponsors (1)

Lead Sponsor	Collaborator
The Belgian Society of Medical Oncology

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of patients with "actionable" driven mutations.		18 months
Primary	Percentage of patients enrolled in genomics-driven clinical trials and in the PRECISION 2 clinical trial.		18 months
Primary	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