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

Yonsei University

Status: Unknown

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

Study type: Observational

Funder types: Other

Identifiers

NCT03485638

4-2016-0811

Details and patient eligibility

About

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.

Full 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

Enrollment: 400 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

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

Trial design

400 participants in 1 patient group

Cetuximab administration