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

NCT02792478 | Completed

• 1 other identifier: 20140381
• Study Type: observational
• Target: 238
• Locations: 1 country
• Sites: 24

Brief Summary

Analysis of freely circulating DNA in liquid biopsies using the BEAMing method

Conditions

RAS Wild Type mCRC

Outcome Measures

Primary Outcomes (1)

• 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).

  Baseline

Secondary Outcomes (2)

• Description of RAS mutations using liquid biopsies at the moment of disease progression

  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.

  at 20+/- 2 weeks after treatment start

Study Arms (2)

RAS wild-type subjects

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.

Patient RAS WT

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Subjects with metastatic colorectal cancer, measurable by RECIST, who start first-line treatment

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Amgen: lead

Study Sites (24)

Research Site

Almería, Andalusia, 04009, Spain

Location

Research Site

Granada, Andalusia, 18014, Spain

Location

Research Site

Seville, Andalusia, 41013, Spain

Location

Research Site

Palma de Mallorca, Balearic Islands, 07198, Spain

Location

Research Site

San Cristóbal de La Laguna, Canary Islands, 38320, Spain

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Research Site

Burgos, Castille and León, 09006, Spain

Location

Research Site

Salamanca, Castille and León, 37007, Spain

Location

Research Site

Lleida, Catalonia, 25198, Spain

Location

Research Site

Terrassa, Catalonia, 08221, Spain

Location

Research Site

Cáceres, Extremadura, 10003, Spain

Location

Research Site

Ourense, Galicia, 32005, Spain

Location

Research Site

Cartagena, Murcia, 30202, Spain

Location

Research Site

Avilés, Principality of Asturias, 33400, Spain

Location

Research Site

Oviedo, Principality of Asturias, 33011, Spain

Location

Research Site

Alicante, Valencia, 03010, Spain

Location

Research Site

Castellon, Valencia, 12002, Spain

Location

Research Site

Valencia, Valencia, 46014, Spain

Location

Research Site

Valencia, Valencia, 46015, Spain

Location

Research Site

Valencia, Valencia, 46026, Spain

Location

Research Site

Madrid, 28009, Spain

Location

Research Site

Madrid, 28034, Spain

Location

Research Site

Madrid, 28041, Spain

Location

Research Site

Madrid, 28046, Spain

Location

Research Site

Murcia, 30008, Spain

Location

Related Publications (1)

• Valladares-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 BACKGROUND

Related Links

• AmgenTrials clinical trials website

Biospecimen

Retention: SAMPLES WITH DNA

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.

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2016
• First Posted: June 7, 2016
• Study Start: May 6, 2016
• Primary Completion: May 31, 2021
• Study Completion: May 31, 2021
• Last Updated: May 13, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication (or other new use) have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
• Access Criteria: Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors, and if not approved, may be further arbitrated by a Data Sharing Independent Review Panel. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the link below.

Locations

ES (24)