Determination of RAS Mutation Status in Liquid Biopsies in Subjects With RAS Wild-type.PERSEIDA Study

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.

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.