Assessment and Prediction of Cetuximab-Induced Hypersensitivity Reactions Using Cetuximab Specific IgE Detection

• Conditions: Tumor Disease Including Colorectal Cancer; Head & Neck Squamous Cell Carcinoma

• Registration Number: NCT03485638
• Lead Sponsor: Yonsei University

Brief Summary

1. Background Cetuximab (trade name Erbitux) is a murine-human chimeric monoclonal antibody to human epidermal growth factor receptor (EGFR). This drug has been used as a treatment for colorectal cancer and head and neck cancer. It is known that allergic reactions can occur in more than 5% of the patients, although the side effects are relatively low compared with other chemotherapeutic agents. It is known that cetuximab can induce hypersensitivity even at the first administration, unlike other anticancer drugs. In this study, we aimed to establish a model to predict patients with hypersensitivity reaction before administration of cetuximab and to provide safe chemotherapy.

2. Recruitment method and consent procedure The study is designed for analysis patients scheduled for administration of cetuximab for the first time. Patients matching the selection and exclusion criteria with voluntary agreement to the study will be enrolled. Enrolled patients will be tested for skin prick test and serum sIgE before cetuximab administration.

Detailed Description

* Acquisition of agreement Agreement, explanation, and consent form for study of human derived sample those that approved by the IRB are obtained from patients who prospectively voluntarily participate in the study and provide human derived sample.

* Observation and evaluation values

① Serum Cetuximab-specific IgE measurement (ImmunoCAP, conventional ELISA) before administration of cetuximab

② Cetuximab Skin test using before cetuximab administration

③ Clinical symptoms after cetuximab administration through chart review (vital signs, occurrence of adverse drug reaction)

④ Check patient's underlying disease and allergy history

* Statistical analysis method Chi-square test, Fisher's exact test, Student t-test, Mann-Whitney test, Logistic regression test, Cox's regression test, and ROC curve will be used

Study Timeline

• Study Start: 2016-11-04
• Study First Submitted: 2018-03-26
• Study First Submitted QC: 2018-03-30
• Study First Posted: 2018-04-02
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-31
• Last Update Posted: 2019-04-02
• Primary Completion: 2020-11-03
• Study Completion: 2020-11-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

• Adult men and women over 18 years of age
• Patients scheduled for cetuximab administration according to standard treatment guidelines for the treatment of underlying tumor disease.

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Exclusion Criteria

• Patients who did not consent to the study voluntarily after IRB approval
• Persons who are vulnerable (including persons with disabilities, lack of physician capacity, pregnant status, persons who are accommodated in facilities, etc.)
• Those who can not read and understand the agreement

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Hypersensitivity reaction after cetuximab administration	Within 4 weeks after first administration	Adverse drug reaction after Cetuximab administration includes severe systemic allergic reaction such as anaphylaxis, urticaria, skin rash, dyspnea, shock and mental change.

Secondary Outcome Measures

Name	Time	Method
Cetuximab specific IgE	within 4 weeks after first administration	Cetuximab specific IgE measured by ImmunoCAP assay, ELISA

Trial Locations

Locations (1)

Division of Allergy and Immunology, Department of Internal Medicine, Yonsei University; 🇰🇷 Seoul, Korea, Republic of