Metastatic CancerNCT03873103
The Belgian Molecular Profiling Program of Metastatic Cancer for Clinical Decision and Treatment Assignment
An observational study of Metastatic Cancer, run by The Belgian Society of Medical Oncology at 10 sites in Belgium.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Metastatic Cancer
- How many people
- 1,000 participants
- Where
- 10 sitesBelgium
- Study dates
- 31 Mar 2019to 31 Dec 2023
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 1000 patients with metastatic solid tumors that are eligible for systemic therapy will be recruited at 7 Belgian academic centers.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
Belgium10 sites, 10 recruiting
- Recruiting
ZNA
Antwerp, 2020
Dirk Schrijvers, Dr
- Recruiting
GZA
Antwerp, 2610
Luc Dirix, Dr
- Recruiting
AZ Klina
Brasschaat, 2930
Charis Loos
Wim Demey, Dr
- Recruiting
Institute Jules Bordet
Brussels, 1000
Anna-Kim Bergström
Philippe Aftimos, Dr
- Recruiting
AZ VUB
Brussels, 1090
Nadia Cappoen
Lore Decoster, Dr
- Recruiting
Les Cliniques Universitaires St Luc
Brussels, 1200
Matthias Papier
François Duhoux, MD
- Recruiting
Universitaire Ziekenhuis Antwerpen
Edegem, 2650
Marika Rasschaert, Dr
- Recruiting
UZ Gent
Ghent, 9000
Lore Vansteelant
Sylvie Rottey, PhD
- Recruiting
CHU Sart-Tilman
Liège, 4000
Hélène Schroeder, hschroeder@chuliege.be
Joelle Collignon, Dr
- Recruiting
AZ Nikolaas
Sint-Niklaas, 9100
Willem Lybaert, Dr
About this study
Official title: The Belgian Molecular Profiling Program of Metastatic Cancer for Clinical Decision and Treatment Assignment - Precision 1
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.
Read more
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
- Medical subject headings
- Neoplasm Metastasis
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients with "actionable" driven mutations.
Measured: 18 months
Percentage of patients enrolled in genomics-driven clinical trials and in the PRECISION 2 clinical trial.
Measured: 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
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2019
- Study start31 Mar 2019
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- The Belgian Society of Medical Oncology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Philippe Aftimos, Dr, Principal investigator, Institute Jules Bordet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03873103
- Sponsor's protocol ID
- BSMO 2014-2
- Status last verified
- Dec 2020
- First submitted
- 11 Mar 2019
- Last updated
- 1 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Belgian Molecular Profiling Program of Metastatic Cancer for Clinical Decision and Treatment Assignment - Precision 1
- ClinicalTrials.gov ID
- NCT03873103
- Acronym / sponsor ID
- BSMO 2014-2
- Conditions
- Metastatic Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- The Belgian Society of Medical OncologyUniversity, hospital or other
- Study start
- 31 Mar 2019 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 13 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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").
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 6 Months
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 1000 patients with metastatic solid tumors that are eligible for systemic therapy will be recruited at 7 Belgian academic centers.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Percentage of patients with "actionable" driven mutations.
Time frame: 18 months
Percentage of patients enrolled in genomics-driven clinical trials and in the PRECISION 2 clinical trial.
Time frame: 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
Time frame: 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Philippe Aftimos, Dr principal investigator
Institute Jules Bordet
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metastatic Cancer, run by The Belgian Society of Medical Oncology at 10 sites in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gordana Raicevic Toungouz, PhD (003226425490, gordana.raicevictoungouz@sciensano.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patients with "actionable" driven mutations. (time frame: 18 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2021; AzTrials last refreshed its copy on 7 Nov 2026.