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Study Complete
Sponsor ID
20140381

Determination of RAS mutation status in liquid biopsies in subjects with RAS wild-type.PERSEIDA studyPERSEIDA

Sponsor ID
20140381
Clinicaltrials.gov ID
NCT02792478
EUCTIS ID
N/A
EudraCT ID
N/A
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Study Details

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

Additional Study Details

Phase
Phase 4
Product
Vectibix/AMG706 Comb
Type
Observational
Masking
N/A
Enrollment
238
Additional Study Details

Protocol Summary

Primary Outcome Measures

Detection rate of RAS mutations in liquid biopsies in subjects with RAS wild-type mCRC at baseline.

Timeframe: Baseline

Secondary Outcome Measures

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

Timeframe: 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.

Timeframe: at 20+/- 2 weeks after treatment start

Locations

Location
Status
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Location
Research Site
Sevilla, Andalucía, Spain, 41013
Status
Recruiting
Location
Research Site
Palma de Mallorca, Baleares, Spain, 07198
Status
Recruiting
Location
Research Site
Madrid, Madrid, Spain, 28041
Status
Recruiting
Location
Research Site
Ourense, Galicia, Spain, 32005
Status
Recruiting
Location
Research Site
Almeria, Andalucía, Spain, 04009
Status
Completed
Location
Research Site
Lleida, Cataluña, Spain, 25198
Status
Recruiting
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Study Info
Age
18+ years
Condition
  • Colorectal Cancer
    • Sex
    All
    Trial Dates
    May 2016 - May 2021
    Inclusion and Exclusion 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.