Analysis of freely circulating DNA in liquid biopsies using the BEAMing method
Analysis of freely circulating DNA in liquid biopsies using the BEAMing method is proposed as a technique that may be useful for analysing the RAS mutation status in different types of cancer. However, first it is necessary to evaluate the concordance between the results obtained in tumour samples and liquid biopsies. Primary objective • To evaluate the RAS mutation status at baseline in liquid biopsies in subjects with RAS wild-type metastatic colorectal cancer. Secondary objectives * To evaluate the appearance of new RAS mutations using liquid biopsies at the moment of disease progression. * To evaluate the appearance of new RAS mutations using liquid biopsies prior to radiological documentation of disease progression.
Study Type
OBSERVATIONAL
Enrollment
238
Research Site
Almería, Andalusia, Spain
Research Site
Granada, Andalusia, Spain
Detection rate of RAS mutations in liquid biopsies in subjects with RAS wild-type mCRC at baseline.
To evaluate the RAS mutation status at baseline in liquid biopsies in two cohorts of subjects with RAS wild-type metastatic colorectal cancer: one analysed with the BEAMing (Sysmex-Inostics) technique (Cohort 1) and the other one analysed with the IdyllaTM (Biocartis) tests (Cohort 2).
Time frame: Baseline
Description of RAS mutations using liquid biopsies at the moment of disease progression
Serial protocol specified radiographic and clinical assessment until disease progression One (plasma DNA) liquid biopsy performed at the time progression is documented. Progression time cannot be determined in advance of it's occurrence.
Time frame: Median time to progression ranges from 12 to 24 months
Description of the RAS mutations using liquid biopsies at 20 +/-2 weeks after starting treatment and prior to the second radiological assessment of the disease.
The percentage of subjects who present RAS mutations in liquid biopsies taken prior to the second disease assessment will be presented.
Time frame: at 20+/- 2 weeks after treatment start
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Research Site
Seville, Andalusia, Spain
Research Site
Palma de Mallorca, Balearic Islands, Spain
Research Site
San Cristóbal de La Laguna, Canary Islands, Spain
Research Site
Burgos, Castille and León, Spain
Research Site
Salamanca, Castille and León, Spain
Research Site
Lleida, Catalonia, Spain
Research Site
Terrassa, Catalonia, Spain
Research Site
Cáceres, Extremadura, Spain
...and 14 more locations