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

NCT03873103 | Unknown

• 1 other identifier: BSMO 2014-2
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 10

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").

Conditions

Metastatic Cancer

Outcome Measures

Primary Outcomes (3)

• 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

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Belgian Society of Medical Oncology: lead

Study Sites (10)

ZNA

Antwerp, 2020, Belgium

RECRUITING

GZA

Antwerp, 2610, Belgium

RECRUITING

AZ Klina

Brasschaat, 2930, Belgium

RECRUITING

Institute Jules Bordet

Brussels, 1000, Belgium

RECRUITING

AZ VUB

Brussels, 1090, Belgium

RECRUITING

Les Cliniques Universitaires St Luc

Brussels, 1200, Belgium

RECRUITING

Universitaire Ziekenhuis Antwerpen

Edegem, 2650, Belgium

RECRUITING

UZ Gent

Ghent, 9000, Belgium

RECRUITING

CHU Sart-Tilman

Liège, 4000, Belgium

RECRUITING

AZ Nikolaas

Sint-Niklaas, 9100, Belgium

RECRUITING

MeSH Terms

Conditions

Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Philippe Aftimos, Dr

  Institute Jules Bordet

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gordana Raicevic Toungouz, PhD

CONTACT

003226425490; gordana.raicevictoungouz@sciensano.be

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2019
• First Posted: March 13, 2019
• Study Start: March 31, 2019
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: June 1, 2021

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

BE (10)