The Belgian Molecular Profiling Program of Metastatic Cancer for Clinical Decision and Treatment Assignment
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| ClinicalTrials.gov Identifier: NCT03873103 |
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Recruitment Status : Unknown
Verified December 2020 by The Belgian Society of Medical Oncology.
Recruitment status was: Recruiting
First Posted : March 13, 2019
Last Update Posted : June 1, 2021
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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 :
- " 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").
| Condition or disease |
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| Metastatic Cancer |
| Study Type : | Observational [Patient Registry] |
| Estimated Enrollment : | 1000 participants |
| Observational Model: | Other |
| Time Perspective: | Prospective |
| Target Follow-Up Duration: | 6 Months |
| Official Title: | The Belgian Molecular Profiling Program of Metastatic Cancer for Clinical Decision and Treatment Assignment - Precision 1 |
| Actual Study Start Date : | March 31, 2019 |
| Estimated Primary Completion Date : | December 31, 2023 |
| Estimated Study Completion Date : | December 31, 2023 |
- 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 ]
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03873103
| Contact: Gordana Raicevic Toungouz, PhD | 003226425490 | gordana.raicevictoungouz@sciensano.be |
| Belgium | |
| ZNA | Recruiting |
| Antwerp, Belgium, 2020 | |
| Principal Investigator: Dirk Schrijvers, Dr | |
| GZA | Recruiting |
| Antwerp, Belgium, 2610 | |
| Principal Investigator: Luc Dirix, Dr | |
| AZ Klina | Recruiting |
| Brasschaat, Belgium, 2930 | |
| Contact: Charis Loos | |
| Principal Investigator: Wim Demey, Dr | |
| Institute Jules Bordet | Recruiting |
| Brussels, Belgium, 1000 | |
| Contact: Anna-Kim Bergström | |
| Principal Investigator: Philippe Aftimos, Dr | |
| AZ VUB | Recruiting |
| Brussels, Belgium, 1090 | |
| Contact: Nadia Cappoen | |
| Principal Investigator: Lore Decoster, Dr | |
| Les Cliniques Universitaires St Luc | Recruiting |
| Brussels, Belgium, 1200 | |
| Contact: Matthias Papier | |
| Principal Investigator: François Duhoux, MD | |
| Universitaire Ziekenhuis Antwerpen | Recruiting |
| Edegem, Belgium, 2650 | |
| Principal Investigator: Marika Rasschaert, Dr | |
| UZ Gent | Recruiting |
| Gent, Belgium, 9000 | |
| Contact: Lore Vansteelant | |
| Principal Investigator: Sylvie Rottey, PhD | |
| CHU Sart-Tilman | Recruiting |
| Liège, Belgium, 4000 | |
| Contact: Hélène Schroeder hschroeder@chuliege.be | |
| Principal Investigator: Joelle Collignon, Dr | |
| AZ Nikolaas | Recruiting |
| Sint-Niklaas, Belgium, 9100 | |
| Principal Investigator: Willem Lybaert, Dr | |
| Principal Investigator: | Philippe Aftimos, Dr | Institute Jules Bordet |
| Responsible Party: | The Belgian Society of Medical Oncology |
| ClinicalTrials.gov Identifier: | NCT03873103 |
| Other Study ID Numbers: |
BSMO 2014-2 |
| First Posted: | March 13, 2019 Key Record Dates |
| Last Update Posted: | June 1, 2021 |
| Last Verified: | December 2020 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Neoplasm Metastasis Neoplasms Neoplasms, Second Primary Neoplastic Processes Pathologic Processes |