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Application value of multiple digital PCR detection of KRAS mutation in ctDNA to predict the efficacy of cetuximab in patients with metastatic colorectal cancer

Application value of multiple digital PCR detection of KRAS mutation in ctDNA to predict the efficacy of cetuximab in patients with metastatic colorectal cancer

Status
Active, not recruiting
Phases
Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2300078035
Enrollment
Unknown
Registered
2023-11-27
Start date
2023-11-30
Completion date
Unknown
Last updated
2023-12-03

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

Conditions

Metastatic colorectal cancer

Interventions

Case series:NO

Sponsors

Qingyuan People's Hospital, the Sixth Affiliated Hospital of Guangzhou Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1) age =18 years old, patients sign informed consent; 2) Patients with metastatic colorectal cancer who are receiving or are planning to receive cetuximab therapy; 3) The presence of at least one RECIST measurable lesion (non-radiotherapy field) confirmed by CT or MRI;

Exclusion criteria

Exclusion criteria: 1) mCRC patients with KRAS, NRAS or BRAF gene mutations were detected by tissue molecular testing; 2) Previous history of organ transplantation, autologous/allogeneic stem cell transplantation; 3) A history of acute or subacute intestinal obstruction, or inflammatory bowel disease; 4) Active severe clinical infection (> Grade 2 NCI-CTCAE version 3.0), including active tuberculosis; 5) Known hypersensitivity or anaphylaxis to any component of the investigational treatment; 6) Pregnancy (confirmed by serum beta-chorionic gonadotropin test) or lactation(YNMT)·

Design outcomes

Primary

MeasureTime frame
Drug resistance ;Detection rate of KRAS mutation;

Secondary

MeasureTime frame
Detection index Sensitivity; specificity;

Countries

China

Contacts

Public ContactJinDuan Lin

Qingyuan People's Hospital, the Sixth Affiliated Hospital of Guangzhou Medical University

linjinduan4@163.com+86 137 2968 0146

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026