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Observational Study of RAS monitoring for RAS/BRAF wild advanced Colorectal Cancer Patients treated with anti EGFR antibody

Observational Study of RAS monitoring for RAS/BRAF wild advanced Colorectal Cancer Patients treated with anti EGFR antibody - RAS-trace

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-jRCT1050210160
Enrollment
40
Registered
2022-01-22
Start date
2022-01-08
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

colorectal cancer RAS BRAF PSSkit sysmex

Interventions

None listed

Sponsors

Kataoka Kozo
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1)Histologically proven for colorectal cancer 2)Clinical Stage III/IV colorectal cancer for which more than 12 cycles of chemotherapy including anti-EGFR therapy is planned. 3)measurable lesions according to RECIST ver1.1 4)No previous history of chemotherapy and radiotherapy 5)Aged 20 years old and over 6)ECOG PS0-1 7)Consent for blood exam for ctDNA analy 8)Written informed consent

Exclusion criteria

Exclusion criteria: 1)Active other malignancies 2)Pregnancy, possible pregnancy or breastfeeding 3)Severe pulmonary fibrosis or emphysema 4)Psychiatric disease 5)Patients requiring systemic steroid medication 6) Grade 2 or greater diarrhea or sensory neuropathy 7)Poorly controlled hypertension 8)History of severe heart disease, heart failure, unstable angina within 6 months or angina attack with 6 months 9) active COVID-19 infection

Design outcomes

Primary

MeasureTime frame
Time to RAS mutations acquired

Secondary

MeasureTime frame
Correlation between time to RAS mutations acquired and disease progression, frequencies of BRAF/PIK3CA mutations in ctDNA, disease free survival and overall survival

Contacts

Public ContactMai Fujimori

The Hospital of Hyogo College of Medicine

ma-fuzimori@hyo-med.ac.jp+81-798-45-6372

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026