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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03873103
Recruitment Status : Recruiting
First Posted : March 13, 2019
Last Update Posted : March 13, 2019
Sponsor:
Information provided by (Responsible Party):
The Belgian Society of Medical Oncology

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").


Condition or disease
Metastatic Cancer

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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
Estimated Study Start Date : March 2019
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 31, 2020



Primary Outcome Measures :
  1. Percentage of patients with "actionable" driven mutations. [ Time Frame: 18 months ]
  2. Percentage of patients enrolled in genomics-driven clinical trials and in the PRECISION 2 clinical trial. [ Time Frame: 18 months ]
  3. 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 ]


Information from the National Library of Medicine

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.


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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
Study Population
1000 patients with metastatic solid tumors that are eligible for systemic therapy will be recruited at 7 Belgian academic centers.
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.

Information from the National Library of Medicine

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


Contacts
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Contact: Gordana Raicevic Toungouz, PhD 003226425490 gordana.raicevictoungouz@sciensano.be

Locations
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Belgium
ZNA Not yet recruiting
Antwerp, Belgium, 2020
Principal Investigator: Dirk Schrijvers, Dr         
GZA Not yet recruiting
Antwerp, Belgium, 2610
Principal Investigator: Luc Dirix, Dr         
AZ Klina Not yet 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 Not yet recruiting
Brussels, Belgium, 1090
Contact: Nadia Cappoen         
Principal Investigator: Lore Decoster, Dr         
Les Cliniques Universitaires St Luc Not yet recruiting
Brussels, Belgium, 1200
Contact: Matthias Papier         
Principal Investigator: François Duhoux, MD         
Universitaire Ziekenhuis Antwerpen Not yet recruiting
Edegem, Belgium, 2650
Principal Investigator: Marika Rasschaert, Dr         
UZ Gent Not yet recruiting
Gent, Belgium, 9000
Contact: Lore Vansteelant         
Principal Investigator: Sylvie Rottey, PhD         
CHU Sart-Tilman Not yet recruiting
Liège, Belgium, 4000
Contact: Hélène Schroeder       hschroeder@chuliege.be   
Principal Investigator: Joelle Collignon, Dr         
AZ Nikolaas Not yet recruiting
Sint-Niklaas, Belgium, 9100
Principal Investigator: Willem Lybaert, Dr         
Sponsors and Collaborators
The Belgian Society of Medical Oncology
Investigators
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Principal Investigator: Philippe Aftimos, Dr Institute Jules Bordet

Additional Information:

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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: March 13, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neoplasm Metastasis
Neoplasms, Second Primary
Neoplasms
Neoplastic Processes
Pathologic Processes