Clinical trial · Observational
The Emergence of RAS Mutations in Metastatic Colorectal Cancer Patients Receiving Cetuximab Treatment
A Non-interventional Uncontrolled Multicenter Study to Investigate the Emergence of RAS Resistance Mutations in RAS Wild Type mCRC Patients Receiving First Line Cetuximab Treatment
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
To evaluate the emergence of RAS mutation in patients with metastatic colorectal cancer, circulating free DNA will be analyzed using mass spectrometric genotyping in subjects during cetuximab treatment. The hypothesis of this study is that acquired RAS mutation is responsible for the resistance to cetuximab treatment in wild-type colorectal cancer. The usefulness of liquid biopsy to monitor dynamic genetic alterations in colorectal cancer during treatment will also be investigated in this study.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Drug Resistance | — | UNRESOLVED | — |
| Mass Spectrometry | — | UNRESOLVED | — |
| RAS-RAF Pathway Deregulation | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cetuximab | Drug | Cetuximab | ALIAS |
| liquid biopsy | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- RAS wild-type colorectal cancer
- description
- RAS mutation of patients who are pathologically diagnosed as metastatic colorectal cancer with RAS wild type genotyping will be evaluated using liquid biopsy during cetuximab treatment.
- interventionNames
- Drug: Cetuximab
- Diagnostic Test: liquid biopsy
Primary outcomes (1)
- measure
- Percentage of detected circulating DNA RAS mutations during 1st line cetuximab exposure.
- timeFrame
- 9 months
- description
- Percentage of detected RAS mutations during cetuximab treatment.
Secondary outcomes (9)
- measure
- Time to onset of newly detected circulating DNA RAS mutation.
- timeFrame
- 9 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
- Maximum age
- 90 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients with histologically proven metastatic colorectal cancer for whom treatment with cetuximab in 1st line setting, is planned as part of routine clinical practice, as per the locally approved label and the best scientific information; the decision to prescribe cetuximab is at the sole discretion of the investigator. The choice of standard chemotherapy regimen for 1st line treatment of colorectal cancer is also at the sole discretion of the Investigator, based upon routine clinical practice. 2. Patients aged 20 years and above. 3. Patients who are molecularly diagnosed as having RAS wild-type mCRC. 4. Patients who are willing to provide blood samples during the study 5. Patients who are willing, and able and give, signed informed consent. Exclusion Criteria: 1. Patients having a history of prior exposure to any anti-EGFR therapy. 2. Contra-indications to cetuximab as per locally approved label.
References
Publications (2)
- DERIVEDTsai HL, Lin CC, Sung YC, Chen SH, Chen LT, Jiang JK, Wang JY. The emergence of RAS mutations in patients with RAS wild-type mCRC receiving cetuximab as first-line treatment: a noninterventional, uncontrolled multicenter study. Br J Cancer. 2023 Oct;129(6):947-955. doi: 10.1038/s41416-023-02366-z. Epub 2023 Jul 24. PMID 37488448
- DERIVEDChen SH, Tsai HL, Jiang JK, Sung YC, Huang CW, Yeh YM, Chen LT, Wang JY. Emergence of RAS mutations in patients with metastatic colorectal cancer receiving cetuximab-based treatment: a study protocol. BMC Cancer. 2019 Jun 28;19(1):640. doi: 10.1186/s12885-019-5826-7. PMID 31253124