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

Completed

• Conditions: RAS Wild Type mCRC

• Registration Number: NCT02792478
• Lead Sponsor: Amgen

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.

Study Timeline

• Study First Submitted: 2016-04-26
• Study Start: 2016-05-06
• Study First Submitted QC: 2016-06-02
• Study First Posted: 2016-06-07
• Primary Completion: 2021-05-31
• Study Completion: 2021-05-31
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-10
• Last Update Posted: 2024-05-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 238

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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.

Trial Locations

Locations (1)

Research Site; 🇪🇸 Murcia, Spain