RAS Wild Type mCRC
Conditions
Brief summary
Analysis of freely circulating DNA in liquid biopsies using the BEAMing method
Detailed description
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.
Interventions
None listed
Sponsors
Amgen
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subjects who give their informed consent in writing * Subjects with metastatic colorectal cancer, measurable by RECIST, who start first-line treatment * Male and female subjects, at least 18 years of age and of any ethnicity * Subjects with a histologically-confirmed diagnosis of colorectal carcinoma with metastatic disease and wild-type RAS.
Exclusion criteria
* Pregnant or breastfeeding women * Subjects who have previously received monoclonal antibodies against EGFR (cetuximab or panitumumab), small-molecule EGFR inhibitors (such as erlotinib) or other biological cancer treatments * History of another solid or haematological tumour in the previous 5 years, except a history of basal cell carcinoma of the skin or pre-invasive cervical cancer * Subjects who are participating or have participated in a clinical trial in the 30 days prior to inclusion.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Detection rate of RAS mutations in liquid biopsies in subjects with RAS wild-type mCRC at baseline. | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Description of RAS mutations using liquid biopsies at the moment of disease progression | Median time to progression ranges from 12 to 24 months | 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. |
| 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. | at 20+/- 2 weeks after treatment start | The percentage of subjects who present RAS mutations in liquid biopsies taken prior to the second disease assessment will be presented. |
Countries
Spain
Outcome results
None listed