Clinical trial NCT02792478: Determination of RAS Mutation Status in Liquid Biopsies in Subjects With RAS Wild-type.PERSEIDA Study
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: RAS Wild Type mCRC
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2016-06-07
Enrollment: 238
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Subjects with metastatic colorectal cancer, measurable by RECIST, who start first-line treatment

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Detection rate of RAS mutations in liquid biopsies in subjects with RAS wild-type mCRC at baseline.
timeFrame: Baseline
Secondary outcomes:
measure: Description of RAS mutations using liquid biopsies at the moment of disease progression
timeFrame: Median time to progression ranges from 12 to 24 months
measure: 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.
timeFrame: at 20+/- 2 weeks after treatment start
Other outcomes:
Locations:
city: Almeria
country: Spain
facility: Research Site
state: Andalucía
city: Granada
country: Spain
facility: Research Site
state: Andalucía
city: Sevilla
country: Spain
facility: Research Site
state: Andalucía
city: Aviles
country: Spain
facility: Research Site
state: Asturias
city: Oviedo
country: Spain
facility: Research Site
state: Asturias
city: Palma de Mallorca
country: Spain
facility: Research Site
state: Baleares
city: La Laguna
country: Spain
facility: Research Site
state: Canarias
city: Burgos
country: Spain
facility: Research Site
state: Castilla León
city: Salamanca
country: Spain
facility: Research Site
state: Castilla León
city: Lleida
country: Spain
facility: Research Site
state: Cataluña
city: Terrassa
country: Spain
facility: Research Site
state: Cataluña
city: Alicante
country: Spain
facility: Research Site
state: Comunidad Valenciana
city: Castellon
country: Spain
facility: Research Site
state: Comunidad Valenciana
city: Valencia
country: Spain
facility: Research Site
state: Comunidad Valenciana
city: Valencia
country: Spain
facility: Research Site
state: Comunidad Valenciana
city: Valencia
country: Spain
facility: Research Site
state: Comunidad Valenciana
city: Caceres
country: Spain
facility: Research Site
state: Extremadura
city: Ourense
country: Spain
facility: Research Site
state: Galicia
city: Cartagena
country: Spain
facility: Research Site
state: Murcia
city: Madrid
country: Spain
facility: Research Site
city: Madrid
country: Spain
facility: Research Site
city: Madrid
country: Spain
facility: Research Site
city: Madrid
country: Spain
facility: Research Site
city: Murcia
country: Spain
facility: Research Site
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References:
citation: 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.