Blood and tumor samples
GeneticEvaluation of the added value of a large molecular profiling panel versus a limited molecular profiling panel
Other names: Evaluation of the added value of a molecular profiling panel
NCT Number: NCT03163732
The PROFILER 02 program is a multicenter, randomized, prospective cohort study aiming to compare the clinical relevance of a large Next-generation sequencing (NGS) panel (FondationOne or FOne panel) versus a limited NGS panel (CONTROL or CTL panel) in patients with advanced solid tumors.
This study will allow adapting the therapeutic management of these patients, if needed, by giving them recommended therapies (commercialized or in ongoing clinical trials), based on the recommendations of the Molecular Tumor Board (MTB).
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Institut Bergonié, Bordeaux, France
The genetic and immunologic profile of the tumor will be determined from archival or fresh collected tumor sample.
For each patient, the tumor genomics data will be reviewed, at time of documented progressive disease, independently by a dedicated MTB to make a recommendation of therapy for a given patient based on its molecular profile. First, the genomics data issued from the panel defined by the randomization will be reviewed and recommended therapy resulting from randomization will be revealed to the Investigator. If a recommended therapy can be identified, this therapy will be recommended.
If none recommended therapy can be identified, the 2nd panel performed will then be reviewed.
In case of confirmed clinical or radiological progression (at Investigator's discretion) and/or unacceptable toxicity as per Investigator judgment during the line of therapy recommended by the MTB, the results of the second panel will be reviewed by MTB. Based on all genomics data available (i.e. randomized and 2nd panels), the MTB will recommend other treatment options. All results will be disclosed to Investigator in order to offer other treatment options.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Evaluation of the added value of a large molecular profiling panel versus a limited molecular profiling panel
Other names: Evaluation of the added value of a molecular profiling panel
Time frame: 28 months
Time frame: 28 months
Time frame: 28 months
Time frame: 28 months
Time frame: 28 months
Evaluate proportion of patients with at least one actionable alteration and for whom a genomically identified recommended therapy could have been initiated considering only the INCa panel with only 16 cancer-related genes already included in CONTROL panel
Time frame: 24 months
Measured from the date of study drugs start to the date of the first objective radiological disease progression using RECIST 1.1 or death.
Time frame: 24 months
the most clinically favorable response recorded from the start of a recommended therapy until the end of treatment, according to RECIST 1.1
Time frame: 24 months
Calculated from date of first documented objective response (i.e., Complete Response or Partial Response) until date of first documented progression disease (measurements according to RECIST 1.1 criteria).
Time frame: 12 months
Measured by the questionnaire EuroQoL-5Dimension-3L
Time frame: 12 months
A Cost-Effectiveness and a Cost-utility Analyses comparing the two molecular profiling strategies.
Time frame: 12 months
A budget impact analysis to estimate the financial consequences of adoption and diffusion of the large FondationOne panel.
Centre Leon Berard
Other
A Multicentric, Prospective Cohort Study Aiming to Evaluate the Added Value of a Large Molecular Profiling Panel (Panel FoundationOne) Versus a Limited Molecular Profiling Panel (Panel CONTROL) in Advanced Solid Tumors.
Acronym: PROFILER 02
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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