Clinical trial · Observational
Determination of RAS Mutation Status in Liquid Biopsies in Subjects With RAS Wild-type.PERSEIDA Study
Determination of RAS Mutation Status in Liquid Biopsies in Subjects With RAS Wild-type Colorectal Cancer in First-line Treatment: a Prospective, Observational Multi-centre Study in Spain. PERSEIDA Study
NCT02792478CI-TRIAL-00077061PERSEIDAcompletedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Analysis of freely circulating DNA in liquid biopsies using the BEAMing method
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| RAS Wild Type mCRC | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (2)
- label
- RAS wild-type subjects
- description
- The blood samples will be collected according to the site's routine clinical practice usually prior to each treatment cycle and at the follow-up visits. Analysis of the RAS mutation status will be carried out on blood samples taken at baseline, on those carried out at 20 +/-2 weeks after the start of treatment (in any case, prior to the second tumour assessment) and on the sample obtained upon progression, coinciding with routine clinical practices for collecting blood. Blood Samples will be collected to all subjects participating (119 subjects.)Objective to evaluate the RAS mutation status at baseline in liquid biopsies in subjects with RAS wild type metastatic colorectal cancer.
- label
- Patient RAS WT
- description
- As in cohort 1 blood samples will be collected for all subjects participating (119) 10 ml will be used for analysis of the RAS mutation status. The mutation status of BRAF and EGFR will be also analysed with the IdyllaTM (Biocartis) tests in this Cohort 2. In 20 patients included in Cohort 2, 10 ml additional taken at baseline will be used in order to determine the RAS mutation status by the BEAMing technique and 10 ml additional taken at disease progression will be used to determine the mutational profile in genes other than RAS by a NGS technique.
Primary outcomes (1)
- measure
- Detection rate of RAS mutations in liquid biopsies in subjects with RAS wild-type mCRC at baseline.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (1)
- BACKGROUNDValladares-Ayerbes M, Safont MJ, Gonzalez Flores E, Garcia-Alfonso P, Aranda E, Munoz AL, Falco Ferrer E, Cirera Nogueras L, Rodriguez-Salas N, Aparicio J, Llanos Munoz M, Pimentel Caceres PP, Castillo Trujillo OA, Vidal Tocino R, Salgado Fernandez M, Salud-Salvia A, Massuti Sureda B, Garcia-Carbonero R, Vicente Conesa MA, Lloansi Vila A; PERSEIDA investigators. Sequential RAS mutations evaluation in cell-free DNA of patients with tissue RAS wild-type metastatic colorectal cancer: the PERSEIDA (Cohort 2) study. Clin Transl Oncol. 2024 Oct;26(10):2640-2651. doi: 10.1007/s12094-024-03487-4. Epub 2024 Apr 20. PMID 38642257